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NCT Number: NCT06433115

Effects of Lean Beef Consumption on Cardiometabolic Health and Gut Microbiome

This study is investigating the benefits of lean beef consumption on cardiometabolic health and gut microbiome.

Recruiting

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Key information

Conditions

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Missouri-Columbia

Columbia, Missouri, 65211, United States

Location status: Recruiting

Location contact

Jaapna Dhillon

CONTACT

[email protected]

573-884-2103

Jaapna Dhillon, PhD

PRINCIPAL_INVESTIGATOR

About this study

The study is a 6-wk randomized, controlled, and parallel arm clinical trial. Participants will be randomized to consume either lean grain-fed beef, lean grass-fed beef, or plant-based meat for 6 weeks. Outcomes assessed will include metabolic, inflammatory, and gut microbiome markers.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Age: 18-45 years of age
  • BMI: 18-35 kg/m2
  • Willingness to consume study foods.
  • Willing to comply with study protocol.
  • Consistent diet and activity patterns for 4 weeks
  • Weight stable (≤5 kg change over the last 3 months)
  • Non-smoker >1 year or more

Exclusion criteria

  • Allergies to foods provided in the study
  • Diabetes
  • Gastrointestinal disease and/or bariatric surgery
  • Uncontrolled hypertension and blood pressure ≥ 180/110
  • Illicit drug use
  • Recent consumption of antibiotics or probiotics
  • Recent start of medications that affect metabolism or appetite.
  • Recent blood donation
  • Drug therapy for coronary artery disease, peripheral artery disease, congestive - heart failure, or dyslipidemia
  • Pregnant or lactating individuals
  • Taste or smell disorders
  • High consumers of red meat or plant-based meat (≥ 4 times/week)

Treatment and study plan

Lean (≥90%) Grass-Fed Beef

Other

The specified amount will be 4 oz. per day or 28 ounces per week for participants with an energy requirement of 2000 kcal.

Lean (≥90%) Grain-Fed Beef

Other

The specified amount will be 4 oz. per day or 28 ounces per week for participants with an energy requirement of 2000 kcal.

Plant-Based Meat

Other

Plant-based meat would be macronutrient matched to the same quantities of meat prescribed for a given energy level.

Primary outcomes

  1. LDL-C concentrations

    Time frame: Baseline, week 6

    Lipid profile

  2. Interleukin-6 concentrations

    Time frame: Baseline, week 6

    Inflammatory marker

  3. Gut microbial alpha-diversity

    Time frame: Baseline, week 6

    Assessed via16S rRNA sequencing

Secondary outcomes

  1. HDL-C concentrations

    Time frame: Baseline, week 6

    Lipid profile

  2. Total cholesterol concentrations

    Time frame: Baseline, week 6

    Lipid profile

  3. Triglyceride concentrations

    Time frame: Baseline, week 6

    Lipid profile

  4. Gut microbiome abundance

    Time frame: Baseline, week 6

    16S rRNA sequencing

  5. LPS-binding protein concentration

    Time frame: Baseline, week 6

    Intestinal permeability marker

  6. Glucose concentrations

    Time frame: Baseline, week 6

    Blood Glucose

  7. Insulin concentrations

    Time frame: Baseline, week 6

    Insulin

  8. Body mass

    Time frame: Baseline, week 3, and week 6

    Measured in kg

  9. Fat mass

    Time frame: Baseline, week 3, and week 6

    Fat mass

  10. Fat-free mass

    Time frame: Baseline, week 3, and week 6

    Fat-free mass

  11. Waist circumference

    Time frame: Baseline, week 3, and week 6

    Waist circumference

  12. Hip circumference

    Time frame: Baseline, week 3, and week 6

    Hip Circumference

  13. Thigh circumference

    Time frame: Baseline, week 3, and week 6

    Thigh Circumference

  14. 24 hour appetite ratings

    Time frame: Baseline, week 6

    24-hour appetite ratings assessed on VAS

  15. Physical activity scores

    Time frame: Baseline, week 6

    Activity assessment using Actigraphs

  16. Total hours of sleep

    Time frame: Baseline, week 6

    Sleep diary

  17. Palatability rating of foods

    Time frame: Baseline, week 3, week 6

    Hedonic general labelled magnitude scale (gLMS)

  18. Acceptance rating of foods

    Time frame: Baseline, week 3, week 6

    9-point food action rating scale

  19. Taste and flavor intensity ratings of foods

    Time frame: Baseline

    Sensory intensity scales

  20. Gene expression levels

    Time frame: Baseline, week 6

    Transcriptomics analyses

  21. Inflammatory marker concentrations

    Time frame: Baseline, week 6

    Inflammatory markers

  22. Healthy eating index score

    Time frame: Baseline, week 6

    NCI diet history questionnaire

Other outcomes

  1. Metabolite intensities

    Time frame: Baseline, week 6

    Untargeted and targeted metabolomics

  2. Nutrient intakes

    Time frame: Baseline, week 3, week 6

    24 hours dietary recall

Study contacts

Contact information is provided by the study sponsor or research team.

Jaapna Dhillon

CONTACT

[email protected]

573-884-2103

Sponsors and collaborators

Lead sponsor

University of Missouri-Columbia

Other

Registry information

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
May 29, 2024
Registry last updated
Aug 1, 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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