Longitudinal Examination of Metabolic and Behavioral Correlates of Protein Sources

Not Applicable

Active, not recruiting

• Conditions: Health Behavior
• Interventions: Other: Beans/legumes; Other: Beef; Other: Meat analogue

• Registration Number: NCT06089460
• Lead Sponsor: Oklahoma State University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-01-01
• Study First Submitted: 2023-07-28
• Study First Submitted QC: 2023-10-12
• Study First Posted: 2023-10-18
• Primary Completion: 2024-02-01
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-26
• Last Update Posted: 2024-04-29
• Study Completion: 2024-12-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 30

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

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Exclusion Criteria

• Medical condition which precludes consumption of specific foods or whole food groups

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Beans/legumes	Beans/legumes	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.
Beef	Beef	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.
Meat analogue	Meat analogue	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.

Primary Outcome Measures

Name	Time	Method
Body weight	Baseline (week 0), T1 (week 4), T2 (week 8)	In kilograms

Secondary Outcome Measures

Name	Time	Method
Behavioral Activation Scale Reward Responsiveness	Baseline (week 0), T1 (week 4), T2 (week 8)	Score ranges 5-20, higher scores indicate greater reward responsiveness
Ad-Libitum Ultra-Processed Food Consumption	Baseline (week 0), T1 (week 4), T2 (week 8)	Reported in weight of food consumed, greater than or equal to 0 grams
Sensitivity to Punishment and Reward Questionnaire (Reward Questions)	Baseline (week 0), T1 (week 4), T2 (week 8)	Score ranges 0-24, higher indicates greater sensitivity to reward
Dietary patterns (3-day diet records)	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)	Systolic and diastolic (mmHg)
Fasting lipid panels (i.e., total cholesterol, HDL, LDL, VLDL, triglycerides)	Baseline (week 0), T1 (week 4), T2 (week 8)	Total cholesterol (mg/dL), HDL (mg/dL), LDL (mg/dL), triglycerides (mg/dL)
Fasting blood glucose	Baseline (week 0), T1 (week 4), T2 (week 8)	In mg/dL
Yale Food Addiction Scale	Baseline (week 0), T1 (week 4), T2 (week 8)	Continuous score = 0-7 (higher = more symptoms of food addiction)

Trial Locations

Locations (1)

Oklahoma State University; 🇺🇸 Stillwater, Oklahoma, United States