Recruiting

Lean Beef

Sponsor:

University of Missouri-Columbia

Code:

NCT06433115

Conditions

Diet Intervention

Eligibility Criteria

Sex: All

Age: 18 - 45

Healthy Volunteers: Accepted

Interventions

Lean (≥90%) Grass-Fed Beef

Lean (≥90%) Grain-Fed Beef

Plant-Based Meat

Study Details

Brief summary:

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

Conditions

Diet Intervention

Study ID

NCT06433115

Start date

Jun 11, 2024

Status verified date

Jul, 2025

Completion date

Dec 1, 2027

Anticipated

Primary completion date

Dec 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 45

Healthy Volunteers: Accepted

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)

Study Design

Enrollment

90 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Lean (≥90%) Grass-Fed Beef

The quantity of beef will be adjusted or normalized based on their individual energy requirements. The specified amount will be 4 oz. per day or 28 ounces per week for participants with an energy requirement of 2000 kcal. Participants will consume meals for six weeks.

experimental: Lean (≥90%) Grain-Fed Beef

The quantity of beef will be adjusted or normalized based on their individual energy requirements. The specified amount will be 4 oz. per day or 28 ounces per week for participants with an energy requirement of 2000 kcal. Participants will consume meals for six weeks.

active comparator: Plant-Based Meat

Plant-based meat (beyond meat product) would be macronutrient matched to the same quantities of meat prescribed for a given energy level. Participants will consume meals for six weeks.

Interventions

Lean (≥90%) Grass-Fed Beef

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

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

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

Primary outcome measure

  • LDL-C concentrations [ Time Frame: Baseline, week 6 ]
  • Interleukin-6 concentrations [ Time Frame: Baseline, week 6 ]
  • Gut microbial alpha-diversity [ Time Frame: Baseline, week 6 ]

Central Contacts and Locations

Central contacts

Locations

University of Missouri-Columbia

Recruiting

Columbia, Missouri, United States, 65211

Contacts

Principal Investigator:

Jaapna Dhillon, PhD

More Information

Sponsor

University of Missouri-Columbia

Last update posted

Aug 1, 2025

Last verified

Jul, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Missouri-Columbia on 2025-08-01.