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.

Study Overview

• Status: Recruiting
• Conditions: Diet Intervention
• Intervention / Treatment: Other: Plant-Based Meat; Other: Lean (≥90%) Grass-Fed Beef; Other: Lean (≥90%) Grain-Fed Beef

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 90
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jaapna Dhillon; Phone Number: 573-884-2103; Email: jdhillon@missouri.edu

Study Locations

• United States
  • Missouri
    • Columbia, Missouri, United States, 65211
      • Recruiting
      • University of Missouri-Columbia
      • Principal Investigator: Jaapna Dhillon, PhD
      • Contact: Jaapna Dhillon; Phone Number: 573-884-2103; Email: jdhillon@missouri.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Other: Plant-Based Meat; Plant-based meat would be macronutrient matched to the same quantities of meat prescribed for a given energy level.
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.	Other: 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.
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.	Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Body mass	Measured in kg	Baseline, week 3, and week 6
Palatability rating of foods	Hedonic general labelled magnitude scale (gLMS)	Baseline, week 3, week 6
Acceptance rating of foods	9-point food action rating scale	Baseline, week 3, week 6
HDL-C concentrations	Lipid profile	Baseline, week 6
Total cholesterol concentrations	Lipid profile	Baseline, week 6
Triglyceride concentrations	Lipid profile	Baseline, week 6
Gut microbiome abundance	16S rRNA sequencing	Baseline, week 6
LPS-binding protein concentration	Intestinal permeability marker	Baseline, week 6
Glucose concentrations	Blood Glucose	Baseline, week 6
Insulin concentrations	Insulin	Baseline, week 6
Fat mass	Fat mass	Baseline, week 3, and week 6
Fat-free mass	Fat-free mass	Baseline, week 3, and week 6
Waist circumference	Waist circumference	Baseline, week 3, and week 6
Hip circumference	Hip Circumference	Baseline, week 3, and week 6
Thigh circumference	Thigh Circumference	Baseline, week 3, and week 6
24 hour appetite ratings	24-hour appetite ratings assessed on VAS	Baseline, week 6
Physical activity scores	Activity assessment using Actigraphs	Baseline, week 6
Total hours of sleep	Sleep diary	Baseline, week 6
Taste and flavor intensity ratings of foods	Sensory intensity scales	Baseline
Gene expression levels	Transcriptomics analyses	Baseline, week 6
Inflammatory marker concentrations	Inflammatory markers	Baseline, week 6
Healthy eating index score	NCI diet history questionnaire	Baseline, week 6

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Metabolite intensities	Untargeted and targeted metabolomics	Baseline, week 6
Nutrient intakes	24 hours dietary recall	Baseline, week 3, week 6

Collaborators and Investigators

• Sponsor: University of Missouri-Columbia
• Investigators: Principal Investigator: Jaapna Dhillon, PhD, University of Missouri-Columbia

Study record dates

Study Major Dates

• Study Start (Actual): June 11, 2024
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: April 29, 2024
• First Submitted That Met QC Criteria: May 22, 2024
• First Posted (Actual): May 29, 2024

Study Record Updates

• Last Update Posted (Actual): August 1, 2025
• Last Update Submitted That Met QC Criteria: July 29, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: 2097458 (Other Identifier: University of Missouri)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual participant data that underlie the results reported here after deidentification (ie; text, tables, figures, and appendices)
• IPD Sharing Time Frame: Immediately following publication. No end date.
• IPD Sharing Access Criteria: Data will be deposited in online repositories
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No