Effects of Lean Beef Consumption on Cardiometabolic Health and Gut Microbiome

Not Applicable

Recruiting

• Conditions: Diet Intervention
• Interventions: Other: Lean (93%) Grain-Fed Beef; Other: Plant-Based Meat; Other: Lean (93%) Grass-Fed Beef

• Registration Number: NCT06433115
• Lead Sponsor: University of Missouri-Columbia

Brief Summary

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

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 Timeline

• Study First Submitted: 2024-04-29
• Study First Submitted QC: 2024-05-22
• Study First Posted: 2024-05-29
• Study Start: 2024-06-11
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-09
• Last Update Posted: 2024-07-11
• Primary Completion: 2027-12-01
• Study Completion: 2027-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 90

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
• Recent start of medications that affect metabolism or appetite.
• Drug therapy for coronary artery disease, peripheral artery disease, congestive heart failure, or dyslipidemia
• Pregnant or lactating individuals
• Taste or smell disorders

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lean (93%) Grain-Fed Beef	Lean (93%) 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.
Plant-Based Meat	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.
Lean (93%) Grass-Fed Beef	Lean (93%) 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.

Primary Outcome Measures

Name	Time	Method
LDL-C concentrations	Baseline, week 6	Lipid profile
Gut microbial alpha-diversity	Baseline, week 6	Assessed via16S rRNA sequencing
Interleukin-6 concentrations	Baseline, week 6	Inflammatory marker

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University of Missouri-Columbia; 🇺🇸 Columbia, Missouri, United States