Longitudinal Examination of Metabolic and Behavioral Correlates of Protein Sources

Study Overview
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Brief Summary
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The purpose of this three-arm, pilot, randomized controlled trial is to examine the metabolic and behavioral impacts of consuming a diet characterized by protein from red meat, a meat analogue, or beans/legumes.

Official Title
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Longitudinal Examination of Metabolic and Behavioral Correlates of Various Protein Food Sources

Conditions
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Health Behavior

Intervention / Treatment
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* Other: Beef
* Other: Meat analogue
* Other: Beans/legumes


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18-55 years of age Willingness to consume any of the three protein sources Willingness to stop consumption of any pre- or pro-biotic supplements Willingness to follow a meal plan for four weeks Exclusion Criteria: Medical condition which precludes consumption of specific foods or whole food groups

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Beef<br>Individuals will be asked to consume beef as their only source of protein and follow an individualized meal plan for 4 weeks. Thereafter, they will be instructed to continue beef consumption with any other foods desired for 4 weeks. | Other: Beef<br>* Fresh, locally-sourced, grass-fed, grass-finished ground beef sufficient to meet protein needs based on body weight for 8 weeks<br>|
| Experimental: Meat analogue<br>Individuals will be asked to consume a commercial meat analogue product as their only source of protein and follow an individualized meal plan for 4 weeks. Thereafter, they will be instructed to continue the meat analogue consumption with any other foods desired for 4 weeks. | Other: Meat analogue<br>* Commercially-available and purchased meat analogue sufficient to meet protein needs based on body weight for 8 weeks<br>|
| Experimental: Beans/legumes<br>Individuals will be asked to consume beans/legumes as their only source of protein and follow an individualized meal plan for 4 weeks. Thereafter, they will be instructed to continue the bean/legume consumption with any other foods desired for 4 weeks. | Other: Beans/legumes<br>* Canned beans/legumes sufficient to meet protein needs based on body weight for 8 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body weight |  | Baseline (week 0), T1 (week 4), T2 (week 8) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fasting lipid panels (i.e., total cholesterol, HDL, LDL, VLDL, triglycerides) |  | Baseline (week 0), T1 (week 4), T2 (week 8) | 
| Fasting blood glucose |  | Baseline (week 0), T1 (week 4), T2 (week 8) | 
| Yale Food Addiction Scale | Continuous score = 0-7 (higher = more symptoms of food addiction) | Baseline (week 0), T1 (week 4), T2 (week 8) | 
| Stop Signal Task |  | Baseline (week 0), T1 (week 4), T2 (week 8) | 
| Skin carotenoids |  | Baseline (week 0), T1 (week 4), T2 (week 8) | 
| Blood pressure |  | Baseline (week 0), T1 (week 4), T2 (week 8) | 
| Dietary patterns (3-day diet records) |  | Baseline (week 0), T1 (week 4), T2 (week 8) | 
| Behavioral Activation Scale Reward Responsiveness | Score ranges 5-20, higher scores indicate greater reward responsiveness | Baseline (week 0), T1 (week 4), T2 (week 8) | 
| Ad-Libitum Ultra-Processed Food Consumption |  | Baseline (week 0), T1 (week 4), T2 (week 8) | 
| Salivary Cortisol |  | Baseline (week 0), T1 (week 4), T2 (week 8) | 
| Sensitivity to Punishment and Reward Questionnaire (Reward Questions) | Score ranges 0-24, higher indicates greater sensitivity to reward | Baseline (week 0), T1 (week 4), T2 (week 8) |