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Completed

NCT Number: NCT05589389

Meat And Dietary Pattern Study

The objective of this study is to investigate how different types of meat consumed with two different dietary patterns affect risk for disease.

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Key information

Conditions

Healthy Volunteers

Age range

25 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

USDA-ARS, Beltsville Human Nutrition Research Center

Beltsville, Maryland, 20705, United States

About this study

Association studies have suggested that dietary meat intake may have negative impacts on health. However, these association studies have done a poor job separating meat intake from overall dietary pattern, as well as isolating effects of processed meat from minimally processed meat. Meat is a good source of several essential nutrients, including high quality protein, iron, and vitamin B12. This dietary intervention is designed to investigate the effects of minimally processed meat and further proceeded meat, as part of two different dietary patterns (the typical American dietary pattern and Dietary Guidelines dietary pattern) on outcomes related to chronic diseases.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male or female

Exclusion criteria

  • Younger than 25 years old and older than 80 years old at the beginning of the intervention.
  • Body mass index less than 18 or greater than 40 kg/m2.
  • Blood pressure greater than 160/100 mm Hg or use of medication to treat hypertension for less than 6 months.
  • Use of medications that will affect the study outcomes, including cholesterol lowering medications.
  • Pregnant women, lactating women, women who plan to become pregnant during the study, or women who have given birth during the previous 12 months.
  • Fasting blood glucose over 125 mg/dL or type 2 diabetes requiring medication.
  • Body weight change of 10% in the past 3 months.
  • History of bariatric or other gastrointestinal surgery that would affect digestion.
  • History or presence of diabetes, kidney disease, liver disease, certain cancers, gout, hyperthyroidism, untreated or unstable hypothyroidism, gastrointestinal disease, pancreatic disease, other metabolic diseases, or malabsorption syndromes.
  • Smokers, vapers, or other tobacco users (within 6 months prior to the start of the study).
  • Use of an antibiotic within 1 month of the start of the study or during the study.
  • Plans to have a colonoscopy during the study.
  • Allergy to any food included in the study menus.
  • Unable or unwilling to give informed consent or communicate with study staff.
  • Self-report of alcohol or substance abuse within the past 12 months and/or current acute treatment or rehabilitation program for these problems (long-term participation in Alcoholics Anonymous is not an exclusion).
  • Other medical, psychiatric, or behavioral factors that in the judgment of the Principal Investigator may interfere with study participation or the ability to follow the intervention protocol.

Treatment and study plan

High Healthy Eating Index Diet with Minimally Processed Meat

Other

Participants will consume a diet with a high Healthy Eating Index along with meat that is minimally processed.

High Healthy Eating Index Diet with Further Processed Meat

Other

Participants will consume a diet with a high Healthy Eating Index along with meat that is further processed.

Typical Healthy Eating Index Diet with Minimally Processed Meat

Other

Participants will consume a diet with a typical Healthy Eating Index along with meat that is minimally processed.

Typical Healthy Eating Index Diet with Further Processed Meat

Other

Participants will consume a diet with a typical Healthy Eating Index along with meat that is further processed.

Primary outcomes

  1. Carnitine Concentration

    Time frame: Day 1

    Carnitine, which plays a role to reduce oxidative stress, will be analyzed in blood in units of micromol/L to assess the effect of the intervention on cardiovascular health.

  2. Carnitine Concentration

    Time frame: Day 2

    Carnitine, which plays a role to reduce oxidative stress, will be analyzed in blood in units of micromol/L to assess the effect of the intervention on cardiovascular health.

  3. Carnitine Concentration

    Time frame: Day 35

    Carnitine, which plays a role to reduce oxidative stress, will be analyzed in blood in units of micromol/L to assess the effect of the intervention on cardiovascular health.

  4. Carnitine Concentration

    Time frame: Day 36

    Carnitine, which plays a role to reduce oxidative stress, will be analyzed in blood in units of micromol/L to assess the effect of the intervention on cardiovascular health.

  5. Carnitine Concentration

    Time frame: Day 70

    Carnitine, which plays a role to reduce oxidative stress, will be analyzed in blood in units of micromol/L to assess the effect of the intervention on cardiovascular health.

  6. Carnitine Concentration

    Time frame: Day 71

    Carnitine, which plays a role to reduce oxidative stress, will be analyzed in blood in units of micromol/L to assess the effect of the intervention on cardiovascular health.

  7. Carnitine Concentration

    Time frame: Day 105

    Carnitine, which plays a role to reduce oxidative stress, will be analyzed in blood in units of micromol/L to assess the effect of the intervention on cardiovascular health.

  8. Carnitine Concentration

    Time frame: Day 106

    Carnitine, which plays a role to reduce oxidative stress, will be analyzed in blood in units of micromol/L to assess the effect of the intervention on cardiovascular health.

  9. Carnitine Concentration

    Time frame: Day 140

    Carnitine, which plays a role to reduce oxidative stress, will be analyzed in blood in units of micromol/L to assess the effect of the intervention on cardiovascular health.

  10. Carnitine Concentration

    Time frame: Day 141

    Carnitine, which plays a role to reduce oxidative stress, will be analyzed in blood in units of micromol/L to assess the effect of the intervention on cardiovascular health.

  11. Choline Concentration

    Time frame: Day 1

    Choline, a molecule involved in methyl transfer and lipid formation and support of healthy blood vessels, will be analyzed in blood in units of micromol/L to assess the effect of the intervention on cardiovascular health.

  12. Choline Concentration

    Time frame: Day 2

    Choline, a molecule involved in methyl transfer and lipid formation and support of healthy blood vessels, will be analyzed in blood in units of micromol/L to assess the effect of the intervention on cardiovascular health.

  13. Choline Concentration

    Time frame: Day 35

    Choline, a molecule involved in methyl transfer and lipid formation and support of healthy blood vessels, will be analyzed in blood in units of micromol/L to assess the effect of the intervention on cardiovascular health.

  14. Choline Concentration

    Time frame: Day 36

    Choline, a molecule involved in methyl transfer and lipid formation and support of healthy blood vessels, will be analyzed in blood in units of micromol/L to assess the effect of the intervention on cardiovascular health.

  15. Choline Concentration

    Time frame: Day 70

    Choline, a molecule involved in methyl transfer and lipid formation and support of healthy blood vessels, will be analyzed in blood in units of micromol/L to assess the effect of the intervention on cardiovascular health.

  16. Choline Concentration

    Time frame: Day 71

    Choline, a molecule involved in methyl transfer and lipid formation and support of healthy blood vessels, will be analyzed in blood in units of micromol/L to assess the effect of the intervention on cardiovascular health.

  17. Choline Concentration

    Time frame: Day 105

    Choline, a molecule involved in methyl transfer and lipid formation and support of healthy blood vessels, will be analyzed in blood in units of micromol/L to assess the effect of the intervention on cardiovascular health.

  18. Choline Concentration

    Time frame: Day 106

    Choline, a molecule involved in methyl transfer and lipid formation and support of healthy blood vessels, will be analyzed in blood in units of micromol/L to assess the effect of the intervention on cardiovascular health.

  19. Choline Concentration

    Time frame: Day 140

    Choline, a molecule involved in methyl transfer and lipid formation and support of healthy blood vessels, will be analyzed in blood in units of micromol/L to assess the effect of the intervention on cardiovascular health.

  20. Choline Concentration

    Time frame: Day 141

    Choline, a molecule involved in methyl transfer and lipid formation and support of healthy blood vessels, will be analyzed in blood in units of micromol/L to assess the effect of the intervention on cardiovascular health.

  21. Betaine Concentration

    Time frame: Day 1

    Betaine, which helps make carnitine and supports heart health, will be analyzed in blood in units of micromol/L to assess the effect of the intervention on cardiovascular health.

  22. Betaine Concentration

    Time frame: Day 2

    Betaine, which helps make carnitine and supports heart health, will be analyzed in blood in units of micromol/L to assess the effect of the intervention on cardiovascular health.

  23. Betaine Concentration

    Time frame: Day 35

    Betaine, which helps make carnitine and supports heart health, will be analyzed in blood in units of micromol/L to assess the effect of the intervention on cardiovascular health.

  24. Betaine Concentration

    Time frame: Day 36

    Betaine, which helps make carnitine and supports heart health, will be analyzed in blood in units of micromol/L to assess the effect of the intervention on cardiovascular health.

  25. Betaine Concentration

    Time frame: Day 70

    Betaine, which helps make carnitine and supports heart health, will be analyzed in blood in units of micromol/L to assess the effect of the intervention on cardiovascular health.

  26. Betaine Concentration

    Time frame: Day 71

    Betaine, which helps make carnitine and supports heart health, will be analyzed in blood in units of micromol/L to assess the effect of the intervention on cardiovascular health.

  27. Betaine Concentration

    Time frame: Day 105

    Betaine, which helps make carnitine and supports heart health, will be analyzed in blood in units of micromol/L to assess the effect of the intervention on cardiovascular health.

  28. Betaine Concentration

    Time frame: Day 106

    Betaine, which helps make carnitine and supports heart health, will be analyzed in blood in units of micromol/L to assess the effect of the intervention on cardiovascular health.

  29. Betaine Concentration

    Time frame: Day 140

    Betaine, which helps make carnitine and supports heart health, will be analyzed in blood in units of micromol/L to assess the effect of the intervention on cardiovascular health.

  30. Betaine Concentration

    Time frame: Day 141

    Betaine, which help make carnitine and supports heart health, will be analyzed in blood in units of micromol/L to assess the effect of the intervention on cardiovascular health.

  31. TMA (trimethylamine) Concentration

    Time frame: Day 1

    TMA (trimethylamine), a metabolite of gastrointestinal bacteria, will be analyzed in blood in units of micromol/L to assess the effect of the intervention on cardiovascular health.

  32. TMA (trimethylamine) Concentration

    Time frame: Day 2

    TMA (trimethylamine), a metabolite of gastrointestinal bacteria, will be analyzed in blood in units of micromol/L to assess the effect of the intervention on cardiovascular health.

  33. TMA (trimethylamine) Concentration

    Time frame: Day 35

    TMA (trimethylamine), a metabolite of gastrointestinal bacteria, will be analyzed in blood in units of micromol/L to assess the effect of the intervention on cardiovascular health.

  34. TMA (trimethylamine) Concentration

    Time frame: Day 36

    TMA (trimethylamine), a metabolite of gastrointestinal bacteria, will be analyzed in blood in units of micromol/L to assess the effect of the intervention on cardiovascular health.

  35. TMA (trimethylamine) Concentration

    Time frame: Day 70

    TMA (trimethylamine), a metabolite of gastrointestinal bacteria, will be analyzed in blood in units of micromol/L to assess the effect of the intervention on cardiovascular health.

  36. TMA (trimethylamine) Concentration

    Time frame: Day 71

    TMA (trimethylamine), a metabolite of gastrointestinal bacteria, will be analyzed in blood in units of micromol/L to assess the effect of the intervention on cardiovascular health.

  37. TMA (trimethylamine) Concentration

    Time frame: Day 105

    TMA (trimethylamine), a metabolite of gastrointestinal bacteria, will be analyzed in blood in units of micromol/L to assess the effect of the intervention on cardiovascular health.

  38. TMA (trimethylamine) Concentration

    Time frame: Day 106

    TMA (trimethylamine), a metabolite of gastrointestinal bacteria, will be analyzed in blood in units of micromol/L to assess the effect of the intervention on cardiovascular health.

  39. TMA (trimethylamine) Concentration

    Time frame: Day 140

    TMA (trimethylamine), a metabolite of gastrointestinal bacteria, will be analyzed in blood in units of micromol/L to assess the effect of the intervention on cardiovascular health.

  40. TMA (trimethylamine) Concentration

    Time frame: Day 141

    TMA (trimethylamine), a metabolite of gastrointestinal bacteria, will be analyzed in blood in units of micromol/L to assess the effect of the intervention on cardiovascular health.

  41. TMAO (trimethylamine N-oxide) Concentration

    Time frame: Day 1

    TMAO (trimethylamine N-oxide), a metabolite of gastrointestinal bacteria, will be analyzed in blood in units of micromol/L to assess the effect of the intervention on cardiovascular health.

  42. TMAO (trimethylamine N-oxide) Concentration

    Time frame: Day 2

    TMAO (trimethylamine N-oxide), a metabolite of gastrointestinal bacteria, will be analyzed in blood in units of micromol/L to assess the effect of the intervention on cardiovascular health.

  43. TMAO (trimethylamine N-oxide) Concentration

    Time frame: Day 35

    TMAO (trimethylamine N-oxide), a metabolite of gastrointestinal bacteria, will be analyzed in blood in units of micromol/L to assess the effect of the intervention on cardiovascular health.

  44. TMAO (trimethylamine N-oxide) Concentration

    Time frame: Day 36

    TMAO (trimethylamine N-oxide), a metabolite of gastrointestinal bacteria, will be analyzed in blood in units of micromol/L to assess the effect of the intervention on cardiovascular health.

  45. TMAO (trimethylamine N-oxide) Concentration

    Time frame: Day 70

    TMAO (trimethylamine N-oxide), a metabolite of gastrointestinal bacteria, will be analyzed in blood in units of micromol/L to assess the effect of the intervention on cardiovascular health.

  46. TMAO (trimethylamine N-oxide) Concentration

    Time frame: Day 71

    TMAO (trimethylamine N-oxide), a metabolite of gastrointestinal bacteria, will be analyzed in blood in units of micromol/L to assess the effect of the intervention on cardiovascular health.

  47. TMAO (trimethylamine N-oxide) Concentration

    Time frame: Day 105

    TMAO (trimethylamine N-oxide), a metabolite of gastrointestinal bacteria, will be analyzed in blood in units of micromol/L to assess the effect of the intervention on cardiovascular health.

  48. TMAO (trimethylamine N-oxide) Concentration

    Time frame: Day 106

    TMAO (trimethylamine N-oxide), a metabolite of gastrointestinal bacteria, will be analyzed in blood in units of micromol/L to assess the effect of the intervention on cardiovascular health.

  49. TMAO (trimethylamine N-oxide) Concentration

    Time frame: Day 140

    TMAO (trimethylamine N-oxide), a metabolite of gastrointestinal bacteria, will be analyzed in blood in units of micromol/L to assess the effect of the intervention on cardiovascular health.

  50. TMAO (trimethylamine N-oxide) Concentration

    Time frame: Day 141

    TMAO (trimethylamine N-oxide), a metabolite of gastrointestinal bacteria, will be analyzed in blood in units of micromol/L to assess the effect of the intervention on cardiovascular health.

  51. Total Cholesterol Concentration

    Time frame: Day 1

    Total cholesterol will be analyzed in blood in units of mg/dl to assess the effect of the intervention on cardiovascular health.

  52. Total Cholesterol Concentration

    Time frame: Day 2

    Total cholesterol will be analyzed in blood in units of mg/dl to assess the effect of the intervention on cardiovascular health.

  53. Total Cholesterol Concentration

    Time frame: Day 35

    Total cholesterol will be analyzed in blood in units of mg/dl to assess the effect of the intervention on cardiovascular health.

  54. Total Cholesterol Concentration

    Time frame: Day 36

    Total cholesterol will be analyzed in blood in units of mg/dl to assess the effect of the intervention on cardiovascular health.

  55. Total Cholesterol Concentration

    Time frame: Day 70

    Total cholesterol will be analyzed in blood in units of mg/dl to assess the effect of the intervention on cardiovascular health.

  56. Total Cholesterol Concentration

    Time frame: Day 71

    Total cholesterol will be analyzed in blood in units of mg/dl to assess the effect of the intervention on cardiovascular health.

  57. Total Cholesterol Concentration

    Time frame: Day 105

    Total cholesterol will be analyzed in blood in units of mg/dl to assess the effect of the intervention on cardiovascular health.

  58. Total Cholesterol Concentration

    Time frame: Day 106

    Total cholesterol will be analyzed in blood in units of mg/dl to assess the effect of the intervention on cardiovascular health.

  59. Total Cholesterol Concentration

    Time frame: Day 140

    Total cholesterol will be analyzed in blood in units of mg/dl to assess the effect of the intervention on cardiovascular health.

  60. Total Cholesterol Concentration

    Time frame: Day 141

    Total cholesterol will be analyzed in blood in units of mg/dl to assess the effect of the intervention on cardiovascular health.

  61. LDL Cholesterol Concentration

    Time frame: Day 1

    LDL cholesterol, including its subfractions LDL1, LDL2, LDL3, and LDL4, will be analyzed in blood in units of mg/dl to assess the effect of the intervention on cardiovascular health.

  62. LDL Cholesterol Concentration

    Time frame: Day 2

    LDL cholesterol, including its subfractions LDL1, LDL2, LDL3, and LDL4, will be analyzed in blood in units of mg/dl to assess the effect of the intervention on cardiovascular health.

  63. LDL Cholesterol Concentration

    Time frame: Day 35

    LDL cholesterol, including its subfractions LDL1, LDL2, LDL3, and LDL4, will be analyzed in blood in units of mg/dl to assess the effect of the intervention on cardiovascular health.

  64. LDL Cholesterol Concentration

    Time frame: Day 36

    LDL cholesterol, including its subfractions LDL1, LDL2, LDL3, and LDL4, will be analyzed in blood in units of mg/dl to assess the effect of the intervention on cardiovascular health.

  65. LDL Cholesterol Concentration

    Time frame: Day 70

    LDL cholesterol, including its subfractions LDL1, LDL2, LDL3, and LDL4, will be analyzed in blood in units of mg/dl to assess the effect of the intervention on cardiovascular health.

  66. LDL Cholesterol Concentration

    Time frame: Day 71

    LDL cholesterol, including its subfractions LDL1, LDL2, LDL3, and LDL4, will be analyzed in blood in units of mg/dl to assess the effect of the intervention on cardiovascular health.

  67. LDL Cholesterol Concentration

    Time frame: Day 105

    LDL cholesterol, including its subfractions LDL1, LDL2, LDL3, and LDL4, will be analyzed in blood in units of mg/dl to assess the effect of the intervention on cardiovascular health.

  68. LDL Cholesterol Concentration

    Time frame: Day 106

    LDL cholesterol, including its subfractions LDL1, LDL2, LDL3, and LDL4, will be analyzed in blood in units of mg/dl to assess the effect of the intervention on cardiovascular health.

  69. LDL Cholesterol Concentration

    Time frame: Day 140

    LDL cholesterol, including its subfractions LDL1, LDL2, LDL3, and LDL4, will be analyzed in blood in units of mg/dl to assess the effect of the intervention on cardiovascular health.

  70. LDL Cholesterol Concentration

    Time frame: Day 141

    LDL cholesterol, including its subfractions LDL1, LDL2, LDL3, and LDL4, will be analyzed in blood in units of mg/dl to assess the effect of the intervention on cardiovascular health.

  71. HDL Cholesterol Concentration

    Time frame: Day 1

    HDL cholesterol, including its subfractions HDL2 and HDL3, will be analyzed in blood in units of mg/dl to assess the effect of the intervention on cardiovascular health.

  72. HDL Cholesterol Concentration

    Time frame: Day 2

    HDL cholesterol, including its subfractions HDL2 and HDL3, will be analyzed in blood in units of mg/dl to assess the effect of the intervention on cardiovascular health.

  73. HDL Cholesterol Concentration

    Time frame: Day 35

    HDL cholesterol, including its subfractions HDL2 and HDL3, will be analyzed in blood in units of mg/dl to assess the effect of the intervention on cardiovascular health.

  74. HDL Cholesterol Concentration

    Time frame: Day 36

    HDL cholesterol, including its subfractions HDL2 and HDL3, will be analyzed in blood in units of mg/dl to assess the effect of the intervention on cardiovascular health.

  75. HDL Cholesterol Concentration

    Time frame: Day 70

    HDL cholesterol, including its subfractions HDL2 and HDL3, will be analyzed in blood in units of mg/dl to assess the effect of the intervention on cardiovascular health.

  76. HDL Cholesterol Concentration

    Time frame: Day 71

    HDL cholesterol, including its subfractions HDL2 and HDL3, will be analyzed in blood in units of mg/dl to assess the effect of the intervention on cardiovascular health.

  77. HDL Cholesterol Concentration

    Time frame: Day 105

    HDL cholesterol, including its subfractions HDL2 and HDL3, will be analyzed in blood in units of mg/dl to assess the effect of the intervention on cardiovascular health.

  78. HDL Cholesterol Concentration

    Time frame: Day 106

    HDL cholesterol, including its subfractions HDL2 and HDL3, will be analyzed in blood in units of mg/dl to assess the effect of the intervention on cardiovascular health.

  79. HDL Cholesterol Concentration

    Time frame: Day 140

    HDL cholesterol, including its subfractions HDL2 and HDL3, will be analyzed in blood in units of mg/dl to assess the effect of the intervention on cardiovascular health.

  80. HDL Cholesterol Concentration

    Time frame: Day 141

    HDL cholesterol, including its subfractions HDL2 and HDL3, will be analyzed in blood in units of mg/dl to assess the effect of the intervention on cardiovascular health.

  81. Triglyceride Concentration

    Time frame: Day 1

    Triglycerides will be analyzed in blood in units of mg/dl to assess the effect of the intervention on cardiovascular health.

  82. Triglyceride Concentration

    Time frame: Day 2

    Triglycerides will be analyzed in blood in units of mg/dl to assess the effect of the intervention on cardiovascular health.

  83. Triglyceride Concentration

    Time frame: Day 35

    Triglycerides will be analyzed in blood in units of mg/dl to assess the effect of the intervention on cardiovascular health.

  84. Triglyceride Concentration

    Time frame: Day 36

    Triglycerides will be analyzed in blood in units of mg/dl to assess the effect of the intervention on cardiovascular health.

  85. Triglyceride Concentration

    Time frame: Day 70

    Triglycerides will be analyzed in blood in units of mg/dl to assess the effect of the intervention on cardiovascular health.

  86. Triglyceride Concentration

    Time frame: Day 71

    Triglycerides will be analyzed in blood in units of mg/dl to assess the effect of the intervention on cardiovascular health.

  87. Triglyceride Concentration

    Time frame: Day 105

    Triglycerides will be analyzed in blood in units of mg/dl to assess the effect of the intervention on cardiovascular health.

  88. Triglyceride Concentration

    Time frame: Day 106

    Triglycerides will be analyzed in blood in units of mg/dl to assess the effect of the intervention on cardiovascular health.

  89. Triglyceride Concentration

    Time frame: Day 140

    Triglycerides will be analyzed in blood in units of mg/dl to assess the effect of the intervention on cardiovascular health.

  90. Triglyceride Concentration

    Time frame: Day 141

    Triglycerides will be analyzed in blood in units of mg/dl to assess the effect of the intervention on cardiovascular health.

  91. Apolipoprotein Concentration

    Time frame: Day 1

    Apolipoproteins AI, AII, and B will be analyzed in blood in units of mg/dl to assess the effect of the intervention on cardiovascular health.

  92. Apolipoprotein Concentration

    Time frame: Day 2

    Apolipoproteins AI, AII, and B will be analyzed in blood in units of mg/dl to assess the effect of the intervention on cardiovascular health.

  93. Apolipoprotein Concentration

    Time frame: Day 35

    Apolipoproteins AI, AII, and B will be analyzed in blood in units of mg/dl to assess the effect of the intervention on cardiovascular health.

  94. Apolipoprotein Concentration

    Time frame: Day 36

    Apolipoproteins AI, AII, and B will be analyzed in blood in units of mg/dl to assess the effect of the intervention on cardiovascular health.

  95. Apolipoprotein Concentration

    Time frame: Day 70

    Apolipoproteins AI, AII, and B will be analyzed in blood in units of mg/dl to assess the effect of the intervention on cardiovascular health.

  96. Apolipoprotein Concentration

    Time frame: Day 71

    Apolipoproteins AI, AII, and B will be analyzed in blood in units of mg/dl to assess the effect of the intervention on cardiovascular health.

  97. Apolipoprotein Concentration

    Time frame: Day 105

    Apolipoproteins AI, AII, and B will be analyzed in blood in units of mg/dl to assess the effect of the intervention on cardiovascular health.

  98. Apolipoprotein Concentration

    Time frame: Day 106

    Apolipoproteins AI, AII, and B will be analyzed in blood in units of mg/dl to assess the effect of the intervention on cardiovascular health.

  99. Apolipoprotein Concentration

    Time frame: Day 140

    Apolipoproteins AI, AII, and B will be analyzed in blood in units of mg/dl to assess the effect of the intervention on cardiovascular health.

  100. Apolipoprotein Concentration

    Time frame: Day 141

    Apolipoproteins AI, AII, and B will be analyzed in blood in units of mg/dl to assess the effect of the intervention on cardiovascular health.

  101. Lipoprotein(a) (Lp(a)) Concentration

    Time frame: Day 1

    Lipoprotein(a) will be analyzed in blood in units of mg/dl to assess the effect of the intervention on cardiovascular health.

  102. Lipoprotein(a) (Lp(a)) Concentration

    Time frame: Day 2

    Lipoprotein(a) will be analyzed in blood in units of mg/dl to assess the effect of the intervention on cardiovascular health.

  103. Lipoprotein(a) (Lp(a)) Concentration

    Time frame: Day 35

    Lipoprotein(a) will be analyzed in blood in units of mg/dl to assess the effect of the intervention on cardiovascular health.

  104. Lipoprotein(a) (Lp(a)) Concentration

    Time frame: Day 36

    Lipoprotein(a) will be analyzed in blood in units of mg/dl to assess the effect of the intervention on cardiovascular health.

  105. Lipoprotein(a) (Lp(a)) Concentration

    Time frame: Day 70

    Lipoprotein(a) will be analyzed in blood in units of mg/dl to assess the effect of the intervention on cardiovascular health.

  106. Lipoprotein(a) (Lp(a)) Concentration

    Time frame: Day 71

    Lipoprotein(a) will be analyzed in blood in units of mg/dl to assess the effect of the intervention on cardiovascular health.

  107. Lipoprotein(a) (Lp(a)) Concentration

    Time frame: Day 105

    Lipoprotein(a) will be analyzed in blood in units of mg/dl to assess the effect of the intervention on cardiovascular health.

  108. Lipoprotein(a) (Lp(a)) Concentration

    Time frame: Day 106

    Lipoprotein(a) will be analyzed in blood in units of mg/dl to assess the effect of the intervention on cardiovascular health.

  109. Lipoprotein(a) (Lp(a)) Concentration

    Time frame: Day 140

    Lipoprotein(a) will be analyzed in blood in units of mg/dl to assess the effect of the intervention on cardiovascular health.

  110. Lipoprotein(a) (Lp(a)) Concentration

    Time frame: Day 141

    Lipoprotein(a) will be analyzed in blood in units of mg/dl to assess the effect of the intervention on cardiovascular health.

  111. Low Density Lipoprotein particle size

    Time frame: Day 1

    Low Density Lipoprotein particle size will be analyzed in blood in units of nm to assess the effect of the intervention on cardiovascular health.

  112. Low Density Lipoprotein particle size

    Time frame: Day 2

    Low Density Lipoprotein particle size will be analyzed in blood in units of nm to assess the effect of the intervention on cardiovascular health.

  113. Low Density Lipoprotein particle size

    Time frame: Day 35

    Low Density Lipoprotein particle size will be analyzed in blood in units of nm to assess the effect of the intervention on cardiovascular health.

  114. Low Density Lipoprotein particle size

    Time frame: Day 36

    Low Density Lipoprotein particle size will be analyzed in blood in units of nm to assess the effect of the intervention on cardiovascular health.

  115. Low Density Lipoprotein particle size

    Time frame: Day 70

    Low Density Lipoprotein particle size will be analyzed in blood in units of nm to assess the effect of the intervention on cardiovascular health.

  116. Low Density Lipoprotein particle size

    Time frame: Day 71

    Low Density Lipoprotein particle size will be analyzed in blood in units of nm to assess the effect of the intervention on cardiovascular health.

  117. Low Density Lipoprotein particle size

    Time frame: Day 105

    Low Density Lipoprotein particle size will be analyzed in blood in units of nm to assess the effect of the intervention on cardiovascular health.

  118. Low Density Lipoprotein particle size

    Time frame: Day 106

    Low Density Lipoprotein particle size will be analyzed in blood in units of nm to assess the effect of the intervention on cardiovascular health.

  119. Low Density Lipoprotein particle size

    Time frame: Day 140

    Low Density Lipoprotein particle size will be analyzed in blood in units of nm to assess the effect of the intervention on cardiovascular health.

  120. Low Density Lipoprotein particle size

    Time frame: Day 141

    Low Density Lipoprotein particle size will be analyzed in blood in units of nm to assess the effect of the intervention on cardiovascular health.

  121. Blood Pressure

    Time frame: Day 1

    Blood pressure (systolic and diastolic) will be measured as mm Hg, as a reflection of cardiovascular health.

  122. Blood Pressure

    Time frame: Day 2

    Blood pressure (systolic and diastolic) will be measured as mm Hg, as a reflection of cardiovascular health.

  123. Blood Pressure

    Time frame: Day 35

    Blood pressure (systolic and diastolic) will be measured as mm Hg, as a reflection of cardiovascular health.

  124. Blood Pressure

    Time frame: Day 36

    Blood pressure (systolic and diastolic) will be measured as mm Hg, as a reflection of cardiovascular health.

  125. Blood Pressure

    Time frame: Day 70

    Blood pressure (systolic and diastolic) will be measured as mm Hg, as a reflection of cardiovascular health.

  126. Blood Pressure

    Time frame: Day 71

    Blood pressure (systolic and diastolic) will be measured as mm Hg, as a reflection of cardiovascular health.

  127. Blood Pressure

    Time frame: Day 105

    Blood pressure (systolic and diastolic) will be measured as mm Hg, as a reflection of cardiovascular health.

  128. Blood Pressure

    Time frame: Day 106

    Blood pressure (systolic and diastolic) will be measured as mm Hg, as a reflection of cardiovascular health.

  129. Blood Pressure

    Time frame: Day 140

    Blood pressure (systolic and diastolic) will be measured as mm Hg, as a reflection of cardiovascular health.

  130. Blood Pressure

    Time frame: Day 141

    Blood pressure (systolic and diastolic) will be measured as mm Hg, as a reflection of cardiovascular health.

Secondary outcomes

  1. Gut microbiota

    Time frame: Day 1

    Fecal samples will be analyzed for bacterial RNA sequences. Bacterial RNA sequences will reflect those bacteria (gut microbiota) who are actively expressing genes (and data will be expressed as operational taxonomic units) and will also reflect which genes are actively being expressed (and data will be expressed as RNA sequences).

  2. Gut microbiota

    Time frame: Day 2

    Fecal samples will be analyzed for bacterial RNA sequences. Bacterial RNA sequences will reflect those bacteria (gut microbiota) who are actively expressing genes (and data will be expressed as operational taxonomic units) and will also reflect which genes are actively being expressed (and data will be expressed as RNA sequences).

  3. Gut microbiota

    Time frame: Day 35

    Fecal samples will be analyzed for bacterial RNA sequences. Bacterial RNA sequences will reflect those bacteria (gut microbiota) who are actively expressing genes (and data will be expressed as operational taxonomic units) and will also reflect which genes are actively being expressed (and data will be expressed as RNA sequences).

  4. Gut microbiota

    Time frame: Day 36

    Fecal samples will be analyzed for bacterial RNA sequences. Bacterial RNA sequences will reflect those bacteria (gut microbiota) who are actively expressing genes (and data will be expressed as operational taxonomic units) and will also reflect which genes are actively being expressed (and data will be expressed as RNA sequences).

  5. Gut microbiota

    Time frame: Day 70

    Fecal samples will be analyzed for bacterial RNA sequences. Bacterial RNA sequences will reflect those bacteria (gut microbiota) who are actively expressing genes (and data will be expressed as operational taxonomic units) and will also reflect which genes are actively being expressed (and data will be expressed as RNA sequences).

  6. Gut microbiota

    Time frame: Day 71

    Fecal samples will be analyzed for bacterial RNA sequences. Bacterial RNA sequences will reflect those bacteria (gut microbiota) who are actively expressing genes (and data will be expressed as operational taxonomic units) and will also reflect which genes are actively being expressed (and data will be expressed as RNA sequences).

  7. Gut microbiota

    Time frame: Day 105

    Fecal samples will be analyzed for bacterial RNA sequences. Bacterial RNA sequences will reflect those bacteria (gut microbiota) who are actively expressing genes (and data will be expressed as operational taxonomic units) and will also reflect which genes are actively being expressed (and data will be expressed as RNA sequences).

  8. Gut microbiota

    Time frame: Day 106

    Fecal samples will be analyzed for bacterial RNA sequences. Bacterial RNA sequences will reflect those bacteria (gut microbiota) who are actively expressing genes (and data will be expressed as operational taxonomic units) and will also reflect which genes are actively being expressed (and data will be expressed as RNA sequences).

  9. Gut microbiota

    Time frame: Day 140

    Fecal samples will be analyzed for bacterial RNA sequences. Bacterial RNA sequences will reflect those bacteria (gut microbiota) who are actively expressing genes (and data will be expressed as operational taxonomic units) and will also reflect which genes are actively being expressed (and data will be expressed as RNA sequences).

  10. Gut microbiota

    Time frame: Day 141

    Fecal samples will be analyzed for bacterial RNA sequences. Bacterial RNA sequences will reflect those bacteria (gut microbiota) who are actively expressing genes (and data will be expressed as operational taxonomic units) and will also reflect which genes are actively being expressed (and data will be expressed as RNA sequences).

  11. Bile acid Concentration

    Time frame: Day 1

    Fecal samples will be analyzed for bile acids (cholic acid, chenodeoxycholic acids, lithocholic acid, and deoxycholic acids) and will be expressed in micromoles. Bile acids reflect gut bacterial activity and impact cancer and other health conditions.

  12. Bile acid Concentration

    Time frame: Day 2

    Fecal samples will be analyzed for bile acids (cholic acid, chenodeoxycholic acids, lithocholic acid, and deoxycholic acids) and will be expressed in micromoles. Bile acids reflect gut bacterial activity and impact cancer and other health conditions.

  13. Bile acid Concentration

    Time frame: Day 35

    Fecal samples will be analyzed for bile acids (cholic acid, chenodeoxycholic acids, lithocholic acid, and deoxycholic acids) and will be expressed in micromoles. Bile acids reflect gut bacterial activity and impact cancer and other health conditions.

  14. Bile acid Concentration

    Time frame: Day 36

    Fecal samples will be analyzed for bile acids (cholic acid, chenodeoxycholic acids, lithocholic acid, and deoxycholic acids) and will be expressed in micromoles. Bile acids reflect gut bacterial activity and impact cancer and other health conditions.

  15. Bile acid Concentration

    Time frame: Day 70

    Fecal samples will be analyzed for bile acids (cholic acid, chenodeoxycholic acids, lithocholic acid, and deoxycholic acids) and will be expressed in micromoles. Bile acids reflect gut bacterial activity and impact cancer and other health conditions.

  16. Bile acid Concentration

    Time frame: Day 71

    Fecal samples will be analyzed for bile acids (cholic acid, chenodeoxycholic acids, lithocholic acid, and deoxycholic acids) and will be expressed in micromoles. Bile acids reflect gut bacterial activity and impact cancer and other health conditions.

  17. Bile acid Concentration

    Time frame: Day 105

    Fecal samples will be analyzed for bile acids (cholic acid, chenodeoxycholic acids, lithocholic acid, and deoxycholic acids) and will be expressed in micromoles. Bile acids reflect gut bacterial activity and impact cancer and other health conditions.

  18. Bile acid Concentration

    Time frame: Day 106

    Fecal samples will be analyzed for bile acids (cholic acid, chenodeoxycholic acids, lithocholic acid, and deoxycholic acids) and will be expressed in micromoles. Bile acids reflect gut bacterial activity and impact cancer and other health conditions.

  19. Bile acid Concentration

    Time frame: Day 140

    Fecal samples will be analyzed for bile acids (cholic acid, chenodeoxycholic acids, lithocholic acid, and deoxycholic acids) and will be expressed in micromoles. Bile acids reflect gut bacterial activity and impact cancer and other health conditions.

  20. Bile acid Concentration

    Time frame: Day 141

    Fecal samples will be analyzed for bile acids (cholic acid, chenodeoxycholic acids, lithocholic acid, and deoxycholic acids) and will be expressed in micromoles. Bile acids reflect gut bacterial activity and impact cancer and other health conditions.

  21. Glucose Concentration

    Time frame: Day 1

    Glucose in blood will be measured in mg/dL as a reflection of glucose regulation.

  22. Glucose Concentration

    Time frame: Day 2

    Glucose in blood will be measured in mg/dL as a reflection of glucose regulation.

  23. Glucose Concentration

    Time frame: Day 35

    Glucose in blood will be measured in mg/dL as a reflection of glucose regulation.

  24. Glucose Concentration

    Time frame: Day 36

    Glucose in blood will be measured in mg/dL as a reflection of glucose regulation.

  25. Glucose Concentration

    Time frame: Day 70

    Glucose in blood will be measured in mg/dL as a reflection of glucose regulation.

  26. Glucose Concentration

    Time frame: Day 71

    Glucose in blood will be measured in mg/dL as a reflection of glucose regulation.

  27. Glucose Concentration

    Time frame: Day 105

    Glucose in blood will be measured in mg/dL as a reflection of glucose regulation.

  28. Glucose Concentration

    Time frame: Day 106

    Glucose in blood will be measured in mg/dL as a reflection of glucose regulation.

  29. Glucose Concentration

    Time frame: Day 140

    Glucose in blood will be measured in mg/dL as a reflection of glucose regulation.

  30. Glucose Concentration

    Time frame: Day 141

    Glucose in blood will be measured in mg/dL as a reflection of glucose regulation.

  31. Insulin Concentration

    Time frame: Day 1

    Insulin will be measured in blood in units of microIU/ml as a reflection of glucose regulation.

  32. Insulin Concentration

    Time frame: Day 2

    Insulin will be measured in blood in units of microIU/ml as a reflection of glucose regulation.

  33. Insulin Concentration

    Time frame: Day 35

    Insulin will be measured in blood in units of microIU/ml as a reflection of glucose regulation.

  34. Insulin Concentration

    Time frame: Day 36

    Insulin will be measured in blood in units of microIU/ml as a reflection of glucose regulation.

  35. Insulin Concentration

    Time frame: Day 70

    Insulin will be measured in blood in units of microIU/ml as a reflection of glucose regulation.

  36. Insulin Concentration

    Time frame: Day 71

    Insulin will be measured in blood in units of microIU/ml as a reflection of glucose regulation.

  37. Insulin Concentration

    Time frame: Day 105

    Insulin will be measured in blood in units of microIU/ml as a reflection of glucose regulation.

  38. Insulin Concentration

    Time frame: Day 106

    Insulin will be measured in blood in units of microIU/ml as a reflection of glucose regulation.

  39. Insulin Concentration

    Time frame: Day 140

    Insulin will be measured in blood in units of microIU/ml as a reflection of glucose regulation.

  40. Insulin Concentration

    Time frame: Day 141

    Insulin will be measured in blood in units of microIU/ml as a reflection of glucose regulation.

  41. Diet Satisfaction

    Time frame: Week 1

    Diet satisfaction will be measured by questionnaire using a visual analogue scale, with responses measured in millimeters, with higher values representing higher satisfaction.

  42. Diet Satisfaction

    Time frame: Week 4

    Diet satisfaction will be measured by questionnaire using a visual analogue scale, with responses measured in millimeters, with higher values representing higher satisfaction.

  43. Diet Satisfaction

    Time frame: Week 5

    Diet satisfaction will be measured by questionnaire using a visual analogue scale, with responses measured in millimeters, with higher values representing higher satisfaction.

  44. Diet Satisfaction

    Time frame: Week 9

    Diet satisfaction will be measured by questionnaire using a visual analogue scale, with responses measured in millimeters, with higher values representing higher satisfaction.

  45. Diet Satisfaction

    Time frame: Week 10

    Diet satisfaction will be measured by questionnaire using a visual analogue scale, with responses measured in millimeters, with higher values representing higher satisfaction.

  46. Diet Satisfaction

    Time frame: Week 14

    Diet satisfaction will be measured by questionnaire using a visual analogue scale, with responses measured in millimeters, with higher values representing higher satisfaction.

  47. Diet Satisfaction

    Time frame: Week 15

    Diet satisfaction will be measured by questionnaire using a visual analogue scale, with responses measured in millimeters, with higher values representing higher satisfaction.

  48. Diet Satisfaction

    Time frame: Week 19

    Diet satisfaction will be measured by questionnaire using a visual analogue scale, with responses measured in millimeters, with higher values representing higher satisfaction.

  49. Hunger and Satiety

    Time frame: Week 1

    Hunger and satiety will be measured by questionnaire using a visual analogue scale, with responses measured in millimeters. Higher mm values for hunger indicate greater hunger; higher mm values for satiety indicate greater satiety.

  50. Hunger and Satiety

    Time frame: Week 4

    Hunger and satiety will be measured by questionnaire using a visual analogue scale, with responses measured in millimeters. Higher mm values for hunger indicate greater hunger; higher mm values for satiety indicate greater satiety.

  51. Hunger and Satiety

    Time frame: Week 5

    Hunger and satiety will be measured by questionnaire using a visual analogue scale, with responses measured in millimeters. Higher mm values for hunger indicate greater hunger; higher mm values for satiety indicate greater satiety.

  52. Hunger and Satiety

    Time frame: Week 9

    Hunger and satiety will be measured by questionnaire using a visual analogue scale, with responses measured in millimeters. Higher mm values for hunger indicate greater hunger; higher mm values for satiety indicate greater satiety.

  53. Hunger and Satiety

    Time frame: Week 10

    Hunger and satiety will be measured by questionnaire using a visual analogue scale, with responses measured in millimeters. Higher mm values for hunger indicate greater hunger; higher mm values for satiety indicate greater satiety.

  54. Hunger and Satiety

    Time frame: Week 14

    Hunger and satiety will be measured by questionnaire using a visual analogue scale, with responses measured in millimeters. Higher mm values for hunger indicate greater hunger; higher mm values for satiety indicate greater satiety.

  55. Hunger and Satiety

    Time frame: Week 15

    Hunger and satiety will be measured by questionnaire using a visual analogue scale, with responses measured in millimeters. Higher mm values for hunger indicate greater hunger; higher mm values for satiety indicate greater satiety.

  56. Hunger and Satiety

    Time frame: Week 19

    Hunger and satiety will be measured by questionnaire using a visual analogue scale, with responses measured in millimeters. Higher mm values for hunger indicate greater hunger; higher mm values for satiety indicate greater satiety.

  57. 24-Hour Dietary Recall

    Time frame: 5 to 7 days before Day 1

    Prior to the start of the intervention, a 24-hour dietary recall interview will be conducted to assess food intake during the previous day. Data will be expressed as specific foods and how much of each food (grams) was consumed. The assessment will occur prior to the start of the dietary intervention, during baseline measurements, at approximately 5 to 7 days, and at approximately 3 to 5 days, and at approximately 1 to 3 days before the start of the dietary intervention (week 1).

  58. 24-Hour Dietary Recall

    Time frame: 3 to 5 days before Day 1

    Prior to the start of the intervention, a 24-hour dietary recall interview will be conducted to assess food intake during the previous day. Data will be expressed as specific foods and how much of each food (grams) was consumed. The assessment will occur prior to the start of the dietary intervention, during baseline measurements, at approximately 5 to 7 days, and at approximately 3 to 5 days, and at approximately 1 to 3 days before the start of the dietary intervention (week 1).

  59. 24-Hour Dietary Recall

    Time frame: 1 to 3 days before Day 1

    Prior to the start of the intervention, a 24-hour dietary recall interview will be conducted to assess food intake during the previous day. Data will be expressed as specific foods and how much of each food (grams) was consumed. The assessment will occur prior to the start of the dietary intervention, during baseline measurements, at approximately 5 to 7 days, and at approximately 3 to 5 days, and at approximately 1 to 3 days before the start of the dietary intervention (week 1).

  60. IL6 Concentration

    Time frame: Day 1

    IL6, which is a measure of inflammation, will be measured in blood in units of pg/ml.

  61. IL6 Concentration

    Time frame: Day 2

    IL6, which is a measure of inflammation, will be measured in blood in units of pg/ml.

  62. IL6 Concentration

    Time frame: Day 35

    IL6, which is a measure of inflammation, will be measured in blood in units of pg/ml.

  63. IL6 Concentration

    Time frame: Day 36

    IL6, which is a measure of inflammation, will be measured in blood in units of pg/ml.

  64. IL6 Concentration

    Time frame: Day 70

    IL6, which is a measure of inflammation, will be measured in blood in units of pg/ml.

  65. IL6 Concentration

    Time frame: Day 71

    IL6, which is a measure of inflammation, will be measured in blood in units of pg/ml.

  66. IL6 Concentration

    Time frame: Day 105

    IL6, which is a measure of inflammation, will be measured in blood in units of pg/ml.

  67. IL6 Concentration

    Time frame: Day 106

    IL6, which is a measure of inflammation, will be measured in blood in units of pg/ml.

  68. IL6 Concentration

    Time frame: Day 140

    IL6, which is a measure of inflammation, will be measured in blood in units of pg/ml.

  69. IL6 Concentration

    Time frame: Day 141

    IL6, which is a measure of inflammation, will be measured in blood in units of pg/ml.

  70. C-Reactive Protein (CRP) Concentration

    Time frame: Day 1

    C-Reactive Protein, which is a measure of inflammation, will be measured in blood in units of ng/ml.

  71. C-Reactive Protein (CRP) Concentration

    Time frame: Day 2

    C-Reactive Protein, which is a measure of inflammation, will be measured in blood in units of ng/ml.

  72. C-Reactive Protein (CRP) Concentration

    Time frame: Day 35

    C-Reactive Protein, which is a measure of inflammation, will be measured in blood in units of ng/ml.

  73. C-Reactive Protein (CRP) Concentration

    Time frame: Day 36

    C-Reactive Protein, which is a measure of inflammation, will be measured in blood in units of ng/ml.

  74. C-Reactive Protein (CRP) Concentration

    Time frame: Day 70

    C-Reactive Protein, which is a measure of inflammation, will be measured in blood in units of ng/ml.

  75. C-Reactive Protein (CRP) Concentration

    Time frame: Day 71

    C-Reactive Protein, which is a measure of inflammation, will be measured in blood in units of ng/ml.

  76. C-Reactive Protein (CRP) Concentration

    Time frame: Day 105

    C-Reactive Protein, which is a measure of inflammation, will be measured in blood in units of ng/ml.

  77. C-Reactive Protein (CRP) Concentration

    Time frame: Day 106

    C-Reactive Protein, which is a measure of inflammation, will be measured in blood in units of ng/ml.

  78. C-Reactive Protein (CRP) Concentration

    Time frame: Day 140

    C-Reactive Protein, which is a measure of inflammation, will be measured in blood in units of ng/ml.

  79. C-Reactive Protein (CRP) Concentration

    Time frame: Day 141

    C-Reactive Protein, which is a measure of inflammation, will be measured in blood in units of ng/ml.

  80. Serum Amyloid A Concentration

    Time frame: Day 1

    Serum Amyloid A, which is a measure of inflammation, will be measured in blood in units of ng/ml.

  81. Serum Amyloid A Concentration

    Time frame: Day 2

    Serum Amyloid A, which is a measure of inflammation, will be measured in blood in units of ng/ml.

  82. Serum Amyloid A Concentration

    Time frame: Day 35

    Serum Amyloid A, which is a measure of inflammation, will be measured in blood in units of ng/ml.

  83. Serum Amyloid A Concentration

    Time frame: Day 36

    Serum Amyloid A, which is a measure of inflammation, will be measured in blood in units of ng/ml.

  84. Serum Amyloid A Concentration

    Time frame: Day 70

    Serum Amyloid A, which is a measure of inflammation, will be measured in blood in units of ng/ml.

  85. Serum Amyloid A Concentration

    Time frame: Day 71

    Serum Amyloid A, which is a measure of inflammation, will be measured in blood in units of ng/ml.

  86. Serum Amyloid A Concentration

    Time frame: Day 105

    Serum Amyloid A, which is a measure of inflammation, will be measured in blood in units of ng/ml.

  87. Serum Amyloid A Concentration

    Time frame: Day 106

    Serum Amyloid A, which is a measure of inflammation, will be measured in blood in units of ng/ml.

  88. Serum Amyloid A Concentration

    Time frame: Day 140

    Serum Amyloid A, which is a measure of inflammation, will be measured in blood in units of ng/ml.

  89. Serum Amyloid A Concentration

    Time frame: Day 141

    Serum Amyloid A, which is a measure of inflammation, will be measured in blood in units of ng/ml.

Sponsors and collaborators

Lead sponsor

USDA Beltsville Human Nutrition Research Center

Fed

Collaborators

  • National Cattlemen's Beef Association, a contractor to the Beef Checkoff

Registry information

Official study title

HS68-Meat And Pattern Study

Important dates

Study start
2022
Primary completion
2023
Study completion
2026
First posted
Oct 21, 2022
Registry last updated
Jun 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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