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Completed

NCT Number: NCT05295719

Combining HIIT and n-3 PUFA to Reduce Inflammation and Improve Metabolic Health

The goal of this project is to understand the combined effects of fish oil and exercise in obesity-associated inflammation. The investigators hypothesize that fish oil will improve gut bacteria profiles, which will in turn potentiate the benefits of an exercise program and improve energy utilization and reduce inflammation and metabolic risk.

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Key information

Conditions

Obesity Body Weight Dyslipidemias Glucose Metabolism Disorders Human Microbiome Hyperinsulinism Inflammation Insulin Resistance Lipid Metabolism Disorders Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Texas Tech Kinesiology Building

Lubbock, Texas, 79406, United States

About this study

Incidence of obesity continues to increase in the United States and worldwide, making its prevention or reduction a public health priority. Nutrition research that can lead to effective prevention strategies is greatly needed. Inflammation is a major underlying cause for obesity, and it is imperative to understand how anti-inflammatory food sources, such as fish oil, could aid in reducing obesity. Moreover, exercise is effective at reducing systemic inflammation and improving insulin resistance. Both exercise and diet can influence health through changes in the gut microbiome; however, no studies have investigated how together these affect gut microbiome and overall metabolic health. The goal is to understand the combined effects of fish oil and exercise in obesity-associated inflammation. The investigators hypothesize that fish oil will improve gut bacteria profiles, which will in turn potentiate the benefits of an exercise program and improve energy utilization and reduce inflammation and metabolic risk. These studies will provide the foundation for development of novel strategies for obesity, inflammation, dyslipidemia and dysglycemia.

The first aim of this study will focus on determining the combined effects of n-3 PUFA and HIIT on improving metabolic risks such as obesity-related markers of inflammation, dyslipidemia, and insulin resistance.

The investigators will test the hypothesis that n-3 PUFA, in addition to HIIT, will have beneficial effects on energy utilization, as well as obesity-related markers of inflammation, dyslipidemia and insulin resistance.

Aim 2.1: Investigate the influence of n-3 PUFA and HIIT on body weight and composition Aim 2.2: Investigate the influence of n-3 PUFA and HIIT on serum markers associated with obesity Aim 2.3: Investigate influence of n-3 PUFA and HIIT on energy utilization/ markers of insulin resistance

The second aim is to determine the combined effects of n-3 polyunsaturated fatty acids (n-3 PUFA) and high-intensity interval training (HIIT) on improving gut dysbiosis.

The investigators will test the hypothesis that n-3 PUFA supplementation will improve gut microbiota composition and related metabolites, which will result in reduced inflammation and ameliorate the metabolic response to a HIIT exercise intervention in an overweight population.

Aim 1.1: Investigate the influence of n-3 PUFA and exercise on gut microbiota composition

Aim 1.2: Investigate the influence of n-3 PUFA and exercise on microbiota produced metabolites

Participants will be randomly allocated to 1 of 4 treatment groups (n = 120), each balanced for sex, BMI, lipid profile, and dietary intake. The goal is to conduct the study in smaller cohorts, such as 10-15 participants/group (n = 40-60).

Participants will first be allocated to two groups: One group will take 4 grams n-3 PUFA (AlaskOmega®) per day (3000 mg EPA and 1000 mg DHA) and one group will take placebo (safflower oil, AlaskOmega®, from Organic Technologies Inc.) for 4 weeks of initial supplementation.

Following this, one group from the treatment and one from the placebo group (creating 4 groups: (1) placebo + low-intensity training (LIT); (2) n-3 PUFA + LIT; (3) placebo + HIIT; (4) n-3 PUFA + HIIT) will also participate in a 4 x 4 HIIT exercise (4 intervals for 4 min at 85-95% HRmax with 3min active recovery at 50-70% HRmax) program utilizing cycle ergometers on 3 days/week conducted in the research lab and under investigator supervision for 4 weeks while continuing supplementation.

If not asked to exercise, participants will be instructed to maintain their normal level of physical activity but will participate in a time-matched session of low-intensity training (50% HRmax) on 3 days/week conducted in the research lab and under investigator supervision.

All participants will wear a heart rate monitor (Polar H10) provided by TTU throughout the training (HIIT and LIT) to monitor exertion level.

Capsules will be administered in a double-blind fashion and will be identical in appearance. Participants will visit the clinic to pick up capsules. To ensure compliance, subjects will be reminded via phone (text message or phone call based on participant preference) to take their capsules and counts will be conducted when they come in for study visits.

As with any acute metabolic or physiological improvements, beneficial effects of exercise on bacterial taxa and resultant metabolite production are quickly reversed with detraining. Thus, it is of interest to determine if fish consumption can ameliorate the negative metabolic and gut effects of detraining.

At the end of the 4-week intervention (week 8), participants will cease engaging in HIIT or LIT for a 2-week detraining period. Participants will continue taking their assigned supplements.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 18-65 years old
  • Overweight/ Obese (BMI ≥ 25 to ≤ 40 kg/m2)
  • Elevated Triglycerides (>150 mg/dL)
  • Prediabetes (fasting blood glucose 100 to 125 mg/dl)

Exclusion criteria

  • Diagnosed with Diabetes or liver disease.
  • Taking BP or diabetes medications.
  • Received antibiotics medications in the last 6 months.
  • Pregnant/ lactating/ Irregular menstrual cycle/ menopausal.
  • Currently following a formal/ structured weight loss program.
  • Currently taking fish oil.
  • Do not have access to smart phone/ computer with internet access.
  • Exercise ≥ 1 time/week or a moderate-high score on the International Physical Activity Questionnaire.
  • Feeling uncomfortable riding bike for 30 minutes.
  • Claustrophobic or unable to stay under the hood for metabolic testing.

Treatment and study plan

Omega-3 Polyunsaturated Fatty Acid

Dietary Supplement

4 grams n-3 PUFA (AlaskOmega®) per day (3000 mg EPA and 1000 mg DHA)

Other names: AlaskOmega

High-intensity interval training

Behavioral

A 4 x 4 high-intensity interval training (HIIT) exercise program 3 days/week for 4 weeks. This will include a 3 min warm up at 15% watt max followed by 4 intervals for 4 min at 65% watt max with 3 min active recovery at 15% watt max.

Other names: HIIT

Safflower oil

Dietary Supplement

4 grams safflower oil (AlaskOmega®) per day

Other names: Placebo

Low-intensity training

Behavioral

A low-intensity training exercise program 3 days/week for 4 weeks. This will include consistently cycling at 50% HRmax for 30 min.

Primary outcomes

  1. Mean Change from Baseline in Serum high-sensitivity C-reactive protein at 4 weeks

    Time frame: Post-Supplementation at week 4

    Serum high-sensitivity C-reactive protein (hs-CRP; mg/L)

  2. Mean Change from Baseline in Interleukin (IL)-6 at 4 weeks

    Time frame: Post-Supplementation at week 4

    Interleukin (IL)-6 (pg/mL)

  3. Mean Change from Baseline in Interleukin (IL)-10 at 4 weeks

    Time frame: Post-Supplementation at week 4

    Interleukin (IL)-10 (pg/mL)

  4. Mean Change from Baseline in Monocyte chemoattractant protein-1 at 4 weeks

    Time frame: Post-Supplementation at week 4

    Monocyte chemoattractant protein-1 (MCP-1; pg/mL)

  5. Mean Change from Baseline in Tumor necrosis factor at 4 weeks

    Time frame: Post-Supplementation at week 4

    Tumor necrosis factor (TNF)-alpha (pg/mL)

  6. Mean Change from Baseline in Total Cholesterol at 4 weeks

    Time frame: Post-Supplementation at week 4

    Total cholesterol (mg/dL)

  7. Mean Change from Baseline in High-density lipoprotein (HDL)at 4 weeks

    Time frame: Post-Supplementation at week 4

    High-density lipoprotein (HDL) (mg/dL)

  8. Mean Change from Baseline in Non-high-density lipoprotein (Non-HDL) at 4 weeks

    Time frame: Post-Supplementation at week 4

    Non-high-density lipoprotein (Non-HDL) (mg/dL)

  9. Mean Change from Baseline in Low-density lipoprotein (LDL) at 4 weeks

    Time frame: Post-Supplementation at week 4

    Low-density lipoprotein (LDL) (mg/dL)

  10. Mean Change from Baseline in Very-low-density lipoprotein (VLDL) at 4 weeks

    Time frame: Post-Supplementation at week 4

    Very-low-density lipoprotein (VLDL) (mg/dL)

  11. Mean Change from Baseline in Triglycerides at 4 weeks

    Time frame: Post-Supplementation at week 4

    Triglycerides (mg/dL).

  12. Mean Change from Baseline in Total/HDL cholesterol at 4 weeks

    Time frame: Post-Supplementation at week 4

    Total/HDL cholesterol (mg/dL)

  13. Mean Change from Baseline in Fasting blood glucose at 4 weeks

    Time frame: Post-supplementation at week 4

    Fasting blood glucose (mg/dL)

  14. Mean Change from Baseline in Insulin at 4 weeks

    Time frame: Post-supplementation at week 4

    Insulin (μU/mL)

  15. Mean Change from Baseline in Total Body Fat Percentage at 4 weeks

    Time frame: Post-Supplementation at week 4

    Total Body Fat Percentage (%BF): The percent of the body that is composed of fat. This will change based on the amount of fat there is as well as the amount of lean mass there is.

  16. Mean Change from Baseline in Body Weight at 4 weeks

    Time frame: Post-Supplementation at week 4

    Body weight (kilograms)

  17. Mean Change from Baseline in Skeletal Muscle Mass Percentage at 4 weeks

    Time frame: Post-Supplementation at week 4

    Skeletal Muscle Mass Percentage (%SMM): The percent of the body that is composed of skeletal muscle. Like %BF, this number is relative to total mass.

  18. Mean Change from Baseline in Serum high-sensitivity C-reactive protein at 8 weeks

    Time frame: Post-Intervention at week 8

    Serum high-sensitivity C-reactive protein (hs-CRP; mg/L)

  19. Mean Change from Baseline in Monocyte chemoattractant protein-1 at 8 weeks

    Time frame: Post-Intervention at week 8

    Monocyte chemoattractant protein-1 (MCP-1; pg/mL)

  20. Mean Change from Baseline in Interleukin (IL)-6 at 8 weeks

    Time frame: Post-Intervention at week 8

    Interleukin (IL)-6 (pg/mL)

  21. Mean Change from Baseline in Interleukin (IL)-10 at 8 weeks

    Time frame: Post-Intervention at week 8

    Interleukin (IL)-10 (pg/mL)

  22. Mean Change from Baseline in Tumor necrosis factor (TNF) at 8 weeks

    Time frame: Post-Intervention at week 8

    Tumor necrosis factor (TNF)-alpha (pg/mL)

  23. Mean Change from Baseline in Total Cholesterol at 8 weeks

    Time frame: Post-Intervention at week 8

    Total Cholesterol (mg/dL)

  24. Mean Change from Baseline in High-density lipoprotein (HDL) at 8 weeks

    Time frame: Post-Intervention at week 8

    High-density lipoprotein (HDL) (mg/dL)

  25. Mean Change from Baseline in Non-high-density lipoprotein (Non-HDL) at 8 weeks

    Time frame: Post-intervention at week 8

    Non-high-density lipoprotein (Non-HDL) (mg/dL)

  26. Mean Change from Baseline in Low-density lipoprotein (LDL) at 8 weeks

    Time frame: Post-Intervention at week 8

    Low-density lipoprotein (LDL) (mg/dL)

  27. Mean Change from Baseline in Very-low-density lipoprotein (VLDL) at 8 weeks

    Time frame: Post-Intervention at week 8

    Very-low-density lipoprotein (VLDL) (mg/dL)

  28. Mean Change from Baseline in Triglycerides at 8 weeks

    Time frame: Post-Intervention at week 8

    Triglycerides (mg/dL).

  29. Mean Change from Baseline in total/HDL cholesterol at 8 weeks

    Time frame: Post-Intervention at week 8

    Total/HDL cholesterol (mg/dL)

  30. Mean Change from Baseline in Fasting blood glucose at 8 weeks

    Time frame: Post-Intervention at week 8

    Fasting blood glucose (mg/dL)

  31. Mean Change from Baseline in Oral glucose tolerance test (OGTT) at 8 weeks

    Time frame: Post-Intervention at week 8

    Oral glucose tolerance test (OGTT). Following ingestion of 75 g oral glucose, blood samples will be drawn every 5-10 minutes for the first 30 minutes then every 30 minutes for the next 90 minutes.

  32. Mean Change from Baseline in Insulin at 8 weeks

    Time frame: Post-Intervention at week 8

    Insulin (μU/mL)

  33. Mean Change from Baseline in Body Weight at 8 weeks

    Time frame: Post-Intervention at week 8

    Body weight (kilograms)

  34. Mean Change from Baseline in Total Body Fat Percentage at 8 weeks

    Time frame: Post-Intervention at week 8

    Total Body Fat Percentage (%BF): The percent of the body that is composed of fat. This will change based on the amount of fat there is as well as the amount of lean mass there is.

  35. Mean Change from Baseline in Skeletal Muscle Mass Percentage at 8 weeks

    Time frame: Post-Intervention at week 8

    Skeletal Muscle Mass Percentage (%SMM): The percent of the body that is composed of skeletal muscle. Like %BF, this number is relative to total mass.

  36. Mean Change from Baseline in Serum high-sensitivity C-reactive protein at 10 weeks

    Time frame: Post-Detraining at week 10

    Serum high-sensitivity C-reactive protein (hs-CRP; mg/L)

  37. Mean Change from Baseline in Interleukin (IL)-6 at 10 weeks

    Time frame: Post-Detraining at week 10

    Interleukin (IL)-6 (pg/mL)

  38. Mean Change from Baseline in Interleukin (IL)-10 at 10 weeks

    Time frame: Post-Detraining at week 10

    Interleukin (IL)-10 (pg/mL)

  39. Mean Change from Baseline in Tumor necrosis factor (TNF) at 10 weeks

    Time frame: Post-Detraining at week 10

    Tumor necrosis factor (TNF)-alpha (pg/mL)

  40. Mean Change from Baseline in Monocyte chemoattractant protein-1 at 10 weeks

    Time frame: Post-Detraining at week 10

    Monocyte chemoattractant protein-1 (MCP-1; pg/mL)

  41. Mean Change from Baseline in Total Cholesterol at 10 weeks

    Time frame: Post-Detraining at week 10

    Total Cholesterol (mg/dL)

  42. Mean Change from Baseline in High-density lipoprotein (HDL) at 10 weeks

    Time frame: Post-Detraining at week 10

    High-density lipoprotein (HDL) (mg/dL)

  43. Mean Change from Baseline in Non-high-density lipoprotein (Non-HDL) at 10 weeks

    Time frame: Post-Detraining at week 10

    Non-high-density lipoprotein (Non-HDL) (mg/dL)

  44. Mean Change from Baseline in Low-density lipoprotein (LDL) at 10 weeks

    Time frame: Post-Detraining at week 10

    Low-density lipoprotein (LDL)(mg/dL)

  45. Mean Change from Baseline in Very-low-density lipoprotein (VLDL) at 10 weeks

    Time frame: Post-Detraining at week 10

    Very-low-density lipoprotein (VLDL) (mg/dL)

  46. Mean Change from Baseline in Total/HDL cholesterol at 10 weeks

    Time frame: Post-Detraining at week 10

    Total/HDL cholesterol (mg/dL)

  47. Mean Change from Baseline in Triglycerides at 10 weeks

    Time frame: Post-Detraining at week 10

    Triglycerides (mg/dL)

  48. Mean Change from Baseline in Insulin at 10 weeks

    Time frame: Post-Detraining at week 10

    Insulin (μU/mL)

  49. Mean Change from Baseline in Fasting blood glucose at 10 weeks

    Time frame: Post-Detraining at week 10

    Fasting blood glucose (mg/dL)

  50. Mean Change from Baseline in Skeletal Muscle Mass Percentage at 10 weeks

    Time frame: Post-Detraining at week 10

    Skeletal Muscle Mass Percentage (%SMM): The percent of the body that is composed of skeletal muscle. Like %BF, this number is relative to total mass.

  51. Mean Change from Baseline in Body weight at 10 weeks

    Time frame: Post-Detraining at week 10

    Body weight (kilograms)

  52. Mean Change from Baseline in Total Body Fat Percentage at 10 weeks

    Time frame: Post-Detraining at week 10

    Total Body Fat Percentage (%BF): The percent of the body that is composed of fat. This will change based on the amount of fat there is as well as the amount of lean mass there is.

  53. Mean Change from Post-Supplementation in Serum high-sensitivity C-reactive protein at 8 weeks

    Time frame: Post-Intervention at week 8

    Serum high-sensitivity C-reactive protein (hs-CRP; mg/L)

  54. Mean Change from Post-Supplementation in Interleukin (IL)-6 at 8 weeks

    Time frame: Post-Intervention at week 8

    Interleukin (IL)-6 (pg/mL)

  55. Mean Change from Post-Supplementation in Interleukin (IL)-10 at 8 weeks

    Time frame: Post-Intervention at week 8

    Interleukin (IL)-10 (pg/mL)

  56. Mean Change from Post-Supplementation in Monocyte chemoattractant protein-1 at 8 weeks

    Time frame: Post-Intervention at week 8

    Monocyte chemoattractant protein-1 (MCP-1; pg/mL)

  57. Mean Change from Post-Supplementation in Tumor necrosis factor (TNF) at 8 weeks

    Time frame: Post-Intervention at week 8

    Tumor necrosis factor (TNF)-alpha (pg/mL)

  58. Mean Change from Post-Supplementation in Total Cholesterol at 8 weeks

    Time frame: Post-Intervention at week 8

    Total Cholesterol (mg/dL)

  59. Mean Change from Post-Supplementation in Total/HDL cholesterol at 8 weeks

    Time frame: Post-Intervention at week 8

    Total/HDL cholesterol (mg/dL)

  60. Mean Change from Post-Supplementation in High-density lipoprotein (HDL) at 8 weeks

    Time frame: Post-Intervention at week 8

    High-density lipoprotein (HDL) (mg/dL)

  61. Mean Change from Post-Supplementation in Non-high-density lipoprotein (Non-HDL) at 8 weeks

    Time frame: Post-Intervention at week 8

    Non-high-density lipoprotein (Non-HDL) (mg/dL)

  62. Mean Change from Post-Supplementation in Low-density lipoprotein (LDL) at 8 weeks

    Time frame: Post-Intervention at week 8

    Low-density lipoprotein (LDL) (mg/dL)

  63. Mean Change from Post-Supplementation in Very-low-density lipoprotein (VLDL) at 8 weeks

    Time frame: Post-Intervention at week 8

    Very-low-density lipoprotein (VLDL) (mg/dL)

  64. Mean Change from Post-Supplementation in Triglycerides at 8 weeks

    Time frame: Post-Intervention at week 8

    Triglycerides (mg/dL)

  65. Mean Change from Post-Supplementation in Insulin at 8 weeks

    Time frame: Post-Intervention at week 8

    Insulin (μU/mL)

  66. Mean Change from Post-Supplementation in Fasting blood glucose at 8 weeks

    Time frame: Post-Intervention at week 8

    Fasting blood glucose (mg/dL)

  67. Mean Change from Post-Supplementation in Body weight at 8 weeks

    Time frame: Post-Intervention at week 8

    Body weight (kilograms)

  68. Mean Change from Post-Supplementation in Total Body Fat Percentage at 8 weeks

    Time frame: Post-Intervention at week 8

    Total Body Fat Percentage (%BF): The percent of the body that is composed of fat. This will change based on the amount of fat there is as well as the amount of lean mass there is.

  69. Mean Change from Post-Intervention in Serum high-sensitivity C-reactive protein at 10 weeks

    Time frame: Post-Detraining at week 10

    Serum high-sensitivity C-reactive protein (hs-CRP; mg/L)

  70. Mean Change from Post-Intervention in Tumor Necrosis Factor (TNF) at 10 weeks

    Time frame: Post-Detraining at week 10

    Tumor necrosis factor (TNF)-alpha (pg/mL)

  71. Mean Change from Post-Intervention in Interleukin (IL)-6 at 10 weeks

    Time frame: Post-Detraining at week 10

    Interleukin (IL)-6 (pg/mL)

  72. Mean Change from Post-Intervention in Interleukin (IL)-10 at 10 weeks

    Time frame: Post-Detraining at week 10

    Interleukin (IL)-10 (pg/mL)

  73. Mean Change from Post-Intervention in Monocyte Chemoattractant Protein-1 at 10 weeks

    Time frame: Post-Detraining at week 10

    Monocyte chemoattractant protein-1 (MCP-1; pg/mL)

  74. Mean Change from Post-Intervention in Total Cholesterol at 10 weeks

    Time frame: Post-Detraining at week 10

    Total Cholesterol (mg/dL)

  75. Mean Change from Post-Intervention in High-density lipoprotein (HDL) at 10 weeks

    Time frame: Post-Detraining at week 10

    High-density lipoprotein (HDL) (mg/dL)

  76. Mean Change from Post-Intervention in Non-high-density lipoprotein (Non-HDL) at 10 weeks

    Time frame: Post-Detraining at week 10

    Non-high-density lipoprotein (Non-HDL) (mg/dL)

  77. Mean Change from Post-Intervention in Low-density lipoprotein (LDL) at 10 weeks

    Time frame: Post-Detraining at week 10

    Low-density lipoprotein (LDL) (mg/dL)

  78. Mean Change from Post-Intervention in Very-low-density lipoprotein (VLDL) at 10 weeks

    Time frame: Post-Detraining at week 10

    Very-low-density lipoprotein (VLDL) (mg/dL)

  79. Mean Change from Post-Intervention in Total/HDL cholesterol at 10 weeks

    Time frame: Post-Detraining at week 10

    Total/HDL cholesterol (mg/dL)

  80. Mean Change from Post-Intervention in Triglycerides at 10 weeks

    Time frame: Post-Detraining at week 10

    Triglycerides (mg/dL)

  81. Mean Change from Post-Intervention in Insulin at 10 weeks

    Time frame: Post-Detraining at week 10

    Insulin (μU/mL)

  82. Mean Change from Post-Intervention in Fasting blood glucose at 10 weeks

    Time frame: Post-Detraining at week 10

    Fasting blood glucose (mg/dL)

  83. Mean Change from Post-Intervention in Body weight at 10 weeks

    Time frame: Post-Detraining at week 10

    Body weight (kilograms)

  84. Mean Change from Post-Intervention in Total Body Fat Percentage at 10 weeks

    Time frame: Post-Detraining at week 10

    Total Body Fat Percentage (%BF): The percent of the body that is composed of fat. This will change based on the amount of fat there is as well as the amount of lean mass there is.

  85. Mean Change from Post-Intervention in Skeletal Muscle Mass Percentage at 10 weeks

    Time frame: Post-Detraining at week 10

    Skeletal Muscle Mass Percentage (%SMM): The percent of the body that is composed of skeletal muscle. Like %BF, this number is relative to total mass.

Secondary outcomes

  1. Mean Change from Baseline in Bacterial Profile at 4 weeks

    Time frame: Post-Supplementation at week 4

    Fecal Microbial DNA (16s Sequencing)

  2. Mean Change from Baseline in Serum Acetate Profile at 4 weeks

    Time frame: Post-Supplementation at week 4

    Serum Acetate (SCFA: gas chromatography analysis)

  3. Mean Change from Baseline in Fecal acetate Profile at 4 weeks

    Time frame: Post-Supplementation at week 4

    Fecal acetate (SCFA: in fecal samples by liquid chromatography tandem mass spectrometry (LC-MS/MS))

  4. Mean Change from Baseline in Propionate Profile at 4 weeks

    Time frame: Post-Supplementation at week 4

    Propionate (liquid chromatography tandem mass spectrometry (LC-MS/MS))

  5. Mean Change from Baseline in Butyrate Profile at 4 weeks

    Time frame: Post-Supplementation at week 4

    Butyrate (liquid chromatography tandem mass spectrometry (LC-MS/MS))

  6. Mean Change from Baseline in Markers of Serum lipopolysaccharides at 4 weeks

    Time frame: Post-Supplementation at week 4

    Serum lipopolysaccharides (LPS, ng/ml)

  7. Mean Change from Baseline in Markers of Serum lipopolysaccharides-binding protein at 4 weeks

    Time frame: Post-Supplementation at week 4

    Serum lipopolysaccharides-binding protein (LBP, pg/ml)

  8. Mean Change from Baseline in Bacterial Profile at 8 weeks

    Time frame: Post-Intervention at week 8

    Fecal Microbial DNA (16s Sequencing)

  9. Mean Change from Baseline in Serum Acetate Profile at 8 weeks

    Time frame: Post-Intervention at week 8

    Serum Acetate (SCFA: gas chromatography analysis)

  10. Mean Change from Baseline in Fecal acetate Profile at 8 weeks

    Time frame: Post-Intervention at week 8

    Fecal acetate (SCFA: in fecal samples by liquid chromatography tandem mass spectrometry (LC-MS/MS))

  11. Mean Change from Baseline in Propionate Profile at 8 weeks

    Time frame: Post-Intervention at week 8

    Propionate (liquid chromatography tandem mass spectrometry (LC-MS/MS))

  12. Mean Change from Baseline in Butyrate Profile at 8 weeks

    Time frame: Post-Intervention at week 8

    Butyrate (liquid chromatography tandem mass spectrometry (LC-MS/MS))

  13. Mean Change from Baseline in Markers of Serum lipopolysaccharides at 8 weeks

    Time frame: Post-Intervention at week 8

    Serum lipopolysaccharides (LPS, ng/ml)

  14. Mean Change from Baseline in Markers of Serum lipopolysaccharides-binding protein at 8 weeks

    Time frame: Post-Intervention at week 8

    Serum lipopolysaccharides-binding protein (LBP, pg/ml)

  15. Mean Change from Baseline in Serum Acetate Profile at 10 weeks

    Time frame: Post-Detraining at week 10

    Serum Acetate (SCFA: gas chromatography analysis)

  16. Mean Change from Baseline in Fecal acetate Profile at 10 weeks

    Time frame: Post-Detraining at week 10

    Fecal acetate (SCFA: in fecal samples by liquid chromatography tandem mass spectrometry (LC-MS/MS))

  17. Mean Change from Baseline in Bacterial Profile at 10 weeks

    Time frame: Post-Detraining at week 10

    Fecal Microbial DNA (16s Sequencing)

  18. Mean Change from Baseline in Propionate Profile at 10 weeks

    Time frame: Post-Detraining at week 10

    Propionate (liquid chromatography tandem mass spectrometry (LC-MS/MS))

  19. Mean Change from Baseline in Butyrate Profile at 10 weeks

    Time frame: Post-Detraining at week 10

    Butyrate (liquid chromatography tandem mass spectrometry (LC-MS/MS))

  20. Mean Change from Baseline in Markers of Serum lipopolysaccharides at 10 weeks

    Time frame: Post-Detraining at week 10

    Serum lipopolysaccharides (LPS, ng/ml)

  21. Mean Change from Baseline in Markers of Serum lipopolysaccharides-binding protein at 10 weeks

    Time frame: Post-Detraining at week 10

    Serum lipopolysaccharides-binding protein (LBP, pg/ml)

  22. Mean Change from Post-Supplementation in Bacterial Profile at 8 weeks

    Time frame: Post-Intervention at week 8

    Fecal Microbial DNA (16s Sequencing)

  23. Mean Change from Post-Supplementation in Serum Acetate Profile at 8 weeks

    Time frame: Post-Intervention at week 8

    Serum Acetate (SCFA: gas chromatography analysis)

  24. Mean Change from Post-Supplementation in Fecal acetate Profile at 8 weeks

    Time frame: Post-Intervention at week 8

    Fecal acetate (SCFA: in fecal samples by liquid chromatography tandem mass spectrometry (LC-MS/MS))

  25. Mean Change from Post-Supplementation in Propionate Profile at 8 weeks

    Time frame: Post-Intervention at week 8

    Propionate (liquid chromatography tandem mass spectrometry (LC-MS/MS))

  26. Mean Change from Post-Supplementation in Butyrate Profile at 8 weeks

    Time frame: Post-Intervention at week 8

    Butyrate (liquid chromatography tandem mass spectrometry (LC-MS/MS))

  27. Mean Change from Post-Supplementation in Markers of Serum lipopolysaccharides at 8 weeks

    Time frame: Post-Intervention at week 8

    Serum lipopolysaccharides (LPS, ng/ml)

  28. Mean Change from Post-Supplementation in Markers of Serum lipopolysaccharides-binding protein at 8 weeks

    Time frame: Post-Intervention at week 8

    Serum lipopolysaccharides-binding protein (LBP, pg/ml)

  29. Mean Change from Post-Intervention in Bacterial Profile at 10 weeks

    Time frame: Post-Detraining at week 10

    Fecal Microbial DNA (16s Sequencing)

  30. Mean Change from Post-Intervention in Serum Acetate Profile at 10 weeks

    Time frame: Post-Detraining at week 10

    Serum Acetate (SCFA: gas chromatography analysis)

  31. Mean Change from Post-Intervention in Fecal acetate Profile at 10 weeks

    Time frame: Post-Detraining at week 10

    Fecal acetate (SCFA: in fecal samples by liquid chromatography tandem mass spectrometry (LC-MS/MS))

  32. Mean Change from Post-Intervention in Propionate Profile at 10 weeks

    Time frame: Post-Detraining at week 10

    Propionate (liquid chromatography tandem mass spectrometry (LC-MS/MS))

  33. Mean Change from Post-Intervention in Butyrate Profile at 10 weeks

    Time frame: Post-Detraining at week 10

    Butyrate (liquid chromatography tandem mass spectrometry (LC-MS/MS))

  34. Mean Change from Post-Intervention in Markers of Serum lipopolysaccharides at 10 weeks

    Time frame: Post-Detraining at week 10

    Serum lipopolysaccharides (LPS, ng/ml)

  35. Mean Change from Post-Intervention in Markers of Serum lipopolysaccharides-binding protein at 10 weeks

    Time frame: Post-Detraining at week 10

    Serum lipopolysaccharides-binding protein (LBP, pg/ml)

Sponsors and collaborators

Lead sponsor

Texas Tech University

Other

Collaborators

  • Texas Tech University Health Sciences Center
  • University of Houston

Registry information

Official study title

Combining Fish Oil and Exercise to Improve Obesity-associated Inflammation

Acronym: HIIT&PUFA

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Mar 25, 2022
Registry last updated
Sep 11, 2025

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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