Diet Intervention
Conditions
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.
Interventions
OTHERLean (≥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.
OTHERLean (≥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.
OTHERPlant-Based Meat
Plant-based meat would be macronutrient matched to the same quantities of meat prescribed for a given energy level.
Sponsors
University of Missouri-Columbia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
Single Blind
Intervention model description
Parallel Assignment
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Gut microbial alpha-diversity | Baseline, week 6 | Assessed via16S rRNA sequencing |
| Interleukin-6 concentrations | Baseline, week 6 | Inflammatory marker |
| LDL-C concentrations | Baseline, week 6 | Lipid profile |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Healthy eating index score | Baseline, week 6 | NCI diet history questionnaire |
| HDL-C concentrations | Baseline, week 6 | Lipid profile |
| Total cholesterol concentrations | Baseline, week 6 | Lipid profile |
| Triglyceride concentrations | Baseline, week 6 | Lipid profile |
| Gut microbiome abundance | Baseline, week 6 | 16S rRNA sequencing |
| LPS-binding protein concentration | Baseline, week 6 | Intestinal permeability marker |
| Glucose concentrations | Baseline, week 6 | Blood Glucose |
| Insulin concentrations | Baseline, week 6 | Insulin |
| Taste and flavor intensity ratings of foods | Baseline | Sensory intensity scales |
| Fat mass | Baseline, week 3, and week 6 | Fat mass |
| Fat-free mass | Baseline, week 3, and week 6 | Fat-free mass |
| Waist circumference | Baseline, week 3, and week 6 | Waist circumference |
| Hip circumference | Baseline, week 3, and week 6 | Hip Circumference |
| Thigh circumference | Baseline, week 3, and week 6 | Thigh Circumference |
| 24 hour appetite ratings | Baseline, week 6 | 24-hour appetite ratings assessed on VAS |
| Physical activity scores | Baseline, week 6 | Activity assessment using Actigraphs |
| Total hours of sleep | Baseline, week 6 | Sleep diary |
| Palatability rating of foods | Baseline, week 3, week 6 | Hedonic general labelled magnitude scale (gLMS) |
| Acceptance rating of foods | Baseline, week 3, week 6 | 9-point food action rating scale |
| Body mass | Baseline, week 3, and week 6 | Measured in kg |
| Gene expression levels | Baseline, week 6 | Transcriptomics analyses |
| Inflammatory marker concentrations | Baseline, week 6 | Inflammatory markers |
Other
| Measure | Time frame | Description |
|---|---|---|
| Nutrient intakes | Baseline, week 3, week 6 | 24 hours dietary recall |
| Metabolite intensities | Baseline, week 6 | Untargeted and targeted metabolomics |
Countries
United States
Contacts
Primary ContactJaapna Dhillon
Outcome results
None listed