MedPath

Longitudinal Examination of Metabolic and Behavioral Correlates of Protein Sources

Not Applicable
Active, not recruiting
Conditions
Health Behavior
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

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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
Body weightBaseline (week 0), T1 (week 4), T2 (week 8)

In kilograms

Secondary Outcome Measures
NameTimeMethod
Behavioral Activation Scale Reward ResponsivenessBaseline (week 0), T1 (week 4), T2 (week 8)

Score ranges 5-20, higher scores indicate greater reward responsiveness

Ad-Libitum Ultra-Processed Food ConsumptionBaseline (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

Skin carotenoidsBaseline (week 0), T1 (week 4), T2 (week 8)
Blood pressureBaseline (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 glucoseBaseline (week 0), T1 (week 4), T2 (week 8)

In mg/dL

Dietary patterns (3-day diet records)Baseline (week 0), T1 (week 4), T2 (week 8)
Yale Food Addiction ScaleBaseline (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

Oklahoma State University
🇺🇸Stillwater, Oklahoma, United States
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