Effects of Lean Beef Consumption on Cardiometabolic Health and Gut Microbiome
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Lean (≥90%) Grass-Fed Beef, Lean (≥90%) Grain-Fed Beef, Plant-Based Meat.
- Who it may be relevant to
- Registry conditions: Diet Intervention. Basic parameters: 18 years — 45 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- 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. - 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. - Other Plant-Based Meat
Plant-based meat would be macronutrient matched to the same quantities of meat prescribed for a given energy level.
Primary outcome measures
- LDL-C concentrations [Time frame: Baseline, week 6]
- Interleukin-6 concentrations [Time frame: Baseline, week 6]
- Gut microbial alpha-diversity [Time frame: Baseline, week 6]
Secondary outcome measures (12)
- HDL-C concentrations [Time frame: Baseline, week 6]
- Total cholesterol concentrations [Time frame: Baseline, week 6]
- Triglyceride concentrations [Time frame: Baseline, week 6]
- Gut microbiome abundance [Time frame: Baseline, week 6]
- LPS-binding protein concentration [Time frame: Baseline, week 6]
- Glucose concentrations [Time frame: Baseline, week 6]
- Insulin concentrations [Time frame: Baseline, week 6]
- Body mass [Time frame: Baseline, week 3, and week 6]
- Fat mass [Time frame: Baseline, week 3, and week 6]
- Fat-free mass [Time frame: Baseline, week 3, and week 6]
- Waist circumference [Time frame: Baseline, week 3, and week 6]
- Hip circumference [Time frame: Baseline, week 3, and week 6]
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 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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- University of Missouri-Columbia — Columbia
Identifiers
NCT: NCT06433115 · 2097458 · 2097458