Effects of Lean Beef Consumption on Cardiometabolic Health and Gut Microbiome

NCT06433115 | Recruiting DMC

• 1 other identifier: 2097458
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Diet Intervention

Outcome Measures

Primary Outcomes (3)

• LDL-C concentrations

  Lipid profile

  Baseline, week 6

• Interleukin-6 concentrations

  Inflammatory marker

  Baseline, week 6

• Gut microbial alpha-diversity

  Assessed via16S rRNA sequencing

  Baseline, week 6

Secondary Outcomes (22)

• HDL-C concentrations

  Baseline, week 6

• Total cholesterol concentrations

  Baseline, week 6

• Triglyceride concentrations

  Baseline, week 6

• Gut microbiome abundance

  Baseline, week 6

• LPS-binding protein concentration

  Baseline, week 6

Other Outcomes (2)

• Metabolite intensities

  Baseline, week 6

• Nutrient intakes

  Baseline, week 3, week 6

Study Arms (3)

Lean (≥90%) Grass-Fed Beef

EXPERIMENTAL

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.

Other: Lean (≥90%) Grass-Fed Beef

Lean (≥90%) Grain-Fed Beef

EXPERIMENTAL

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.

Other: Lean (≥90%) Grain-Fed Beef

Plant-Based Meat

ACTIVE COMPARATOR

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.

Other: Plant-Based Meat

Interventions

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%) Grass-Fed Beef

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.

Lean (≥90%) Grain-Fed Beef

Plant-Based Meat OTHER

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

Plant-Based Meat

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Missouri-Columbia: lead

Study Sites (1)

University of Missouri-Columbia

Columbia, Missouri, 65211, United States

RECRUITING

MeSH Terms

Interventions

Meat Substitutes

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Jaapna Dhillon, PhD

  University of Missouri-Columbia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jaapna Dhillon

CONTACT

573-884-2103; jdhillon@missouri.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Single Blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Parallel Assignment

Study Record Dates

• First Submitted: April 29, 2024
• First Posted: May 29, 2024
• Study Start: June 11, 2024
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: August 1, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Immediately following publication. No end date.
• Access Criteria: Data will be deposited in online repositories

Locations

US (1)