Effects of Lean Beef Consumption on Cardiometabolic Health and Gut Microbiome

Diet Intervention Clinical Trial

Official title:

Effects of Lean Beef Consumption on Cardiometabolic Health and Gut Microbiome

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06433115
• Other study ID #: 2097458
• Secondary ID: 2097458
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 30, 2024
• Est. completion date: December 1, 2027

Study information

• Verified date: May 2024
• Source: University of Missouri-Columbia
• Contact: Jaapna Dhillon
• Phone: 573-884-2103
• Email: jdhillon[@]missouri.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 90
• Est. completion date: December 1, 2027
• Est. primary completion date: December 1, 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Diet Intervention

Intervention

Other:
• Lean (93%) 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 (93%) 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.

Locations

Country	Name	City	State
United States	University of Missouri-Columbia	Columbia	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
University of Missouri-Columbia

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Metabolite intensities	Untargeted and targeted metabolomics	Baseline, week 6
Other	Nutrient intakes	24 hours dietary recall	Baseline, week 3, week 6
Primary	LDL-C concentrations	Lipid profile	Baseline, week 6
Primary	Interleukin-6 concentrations	Inflammatory marker	Baseline, week 6
Primary	Gut microbial alpha-diversity	Assessed via16S rRNA sequencing	Baseline, week 6
Secondary	HDL-C concentrations	Lipid profile	Baseline, week 6
Secondary	Total cholesterol concentrations	Lipid profile	Baseline, week 6
Secondary	Triglyceride concentrations	Lipid profile	Baseline, week 6
Secondary	Gut microbiome abundance	16S rRNA sequencing	Baseline, week 6
Secondary	LPS-binding protein concentration	Intestinal permeability marker	Baseline, week 6
Secondary	Glucose concentrations	Blood Glucose	Baseline, week 6
Secondary	Insulin concentrations	Insulin	Baseline, week 6
Secondary	Body mass	Measured in kg	Baseline, week 3, and week 6
Secondary	Fat mass	Fat mass	Baseline, week 3, and week 6
Secondary	Fat-free mass	Fat-free mass	Baseline, week 3, and week 6
Secondary	Waist circumference	Waist circumference	Baseline, week 3, and week 6
Secondary	Hip circumference	Hip Circumference	Baseline, week 3, and week 6
Secondary	Thigh circumference	Thigh Circumference	Baseline, week 3, and week 6
Secondary	24 hour appetite ratings	24-hour appetite ratings assessed on VAS	Baseline, week 6
Secondary	Physical activity scores	Activity assessment using Actigraphs	Baseline, week 6
Secondary	Total hours of sleep	Sleep diary	Baseline, week 6
Secondary	Palatability rating of foods	Hedonic general labelled magnitude scale (gLMS)	Baseline, week 3, week 6
Secondary	Acceptance rating of foods	9-point food action rating scale	Baseline, week 3, week 6
Secondary	Taste and flavor intensity ratings of foods	Sensory intensity scales	Baseline
Secondary	Gene expression levels	Transcriptomics analyses	Baseline, week 6
Secondary	Inflammatory marker concentrations	Inflammatory markers	Baseline, week 6
Secondary	Healthy eating index score	NCI diet history questionnaire	Baseline, week 6