Clinical trial NCT06433115: Effects of Lean Beef Consumption on Cardiometabolic Health and Gut Microbiome
Official title: Effects of Lean Beef Consumption on Cardiometabolic Health and Gut Microbiome
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Diet Intervention
Lead sponsor: University of Missouri-Columbia
Sponsor class: OTHER
First posted: 2024-05-29
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel Assignment
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: LDL-C concentrations
timeFrame: Baseline, week 6
measure: Interleukin-6 concentrations
timeFrame: Baseline, week 6
measure: Gut microbial alpha-diversity
timeFrame: Baseline, week 6
Secondary outcomes:
measure: HDL-C concentrations
timeFrame: Baseline, week 6
measure: Total cholesterol concentrations
timeFrame: Baseline, week 6
measure: Triglyceride concentrations
timeFrame: Baseline, week 6
measure: Gut microbiome abundance
timeFrame: Baseline, week 6
measure: LPS-binding protein concentration
timeFrame: Baseline, week 6
measure: Glucose concentrations
timeFrame: Baseline, week 6
measure: Insulin concentrations
timeFrame: Baseline, week 6
measure: Body mass
timeFrame: Baseline, week 3, and week 6
measure: Fat mass
timeFrame: Baseline, week 3, and week 6
measure: Fat-free mass
timeFrame: Baseline, week 3, and week 6
measure: Waist circumference
timeFrame: Baseline, week 3, and week 6
measure: Hip circumference
timeFrame: Baseline, week 3, and week 6
measure: Thigh circumference
timeFrame: Baseline, week 3, and week 6
measure: 24 hour appetite ratings
timeFrame: Baseline, week 6
measure: Physical activity scores
timeFrame: Baseline, week 6
measure: Total hours of sleep
timeFrame: Baseline, week 6
measure: Palatability rating of foods
timeFrame: Baseline, week 3, week 6
measure: Acceptance rating of foods
timeFrame: Baseline, week 3, week 6
measure: Taste and flavor intensity ratings of foods
timeFrame: Baseline
measure: Gene expression levels
timeFrame: Baseline, week 6
measure: Inflammatory marker concentrations
timeFrame: Baseline, week 6
measure: Healthy eating index score
timeFrame: Baseline, week 6
Other outcomes:
measure: Metabolite intensities
timeFrame: Baseline, week 6
measure: Nutrient intakes
timeFrame: Baseline, week 3, week 6
Locations:
city: Columbia
country: United States
facility: University of Missouri-Columbia
state: Missouri
Study officials:
affiliation: University of Missouri-Columbia
name: Jaapna Dhillon, PhD
role: PRINCIPAL_INVESTIGATOR
References: