Longitudinal Examination of Metabolic and Behavioral Correlates of Protein Sources

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Health Behavior
• Intervention / Treatment: Other: Beef; Other: Meat analogue; Other: Beans/legumes

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Oklahoma
    • Stillwater, Oklahoma, United States, 74078
      • Oklahoma State University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: Beef; Fresh, locally-sourced, grass-fed, grass-finished ground beef sufficient to meet protein needs based on body weight for 8 weeks
Experimental: 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.	Other: Meat analogue; Commercially-available and purchased meat analogue sufficient to meet protein needs based on body weight for 8 weeks
Experimental: 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.	Other: Beans/legumes; Canned beans/legumes sufficient to meet protein needs based on body weight for 8 weeks

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Yale Food Addiction Scale	Continuous score = 0-7 (higher = more symptoms of food addiction)	Baseline (week 0), T1 (week 4), T2 (week 8)
Skin carotenoids		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)
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)
Fasting lipid panels (i.e., total cholesterol, HDL, LDL, VLDL, triglycerides)	Total cholesterol (mg/dL), HDL (mg/dL), LDL (mg/dL), triglycerides (mg/dL)	Baseline (week 0), T1 (week 4), T2 (week 8)
Fasting blood glucose	In mg/dL	Baseline (week 0), T1 (week 4), T2 (week 8)
Blood pressure	Systolic and diastolic (mmHg)	Baseline (week 0), T1 (week 4), T2 (week 8)
Ad-Libitum Ultra-Processed Food Consumption	Reported in weight of food consumed, greater than or equal to 0 grams	Baseline (week 0), T1 (week 4), T2 (week 8)

Collaborators and Investigators

• Sponsor: Oklahoma State University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2023
• Primary Completion (Actual): February 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: July 28, 2023
• First Submitted That Met QC Criteria: October 12, 2023
• First Posted (Actual): October 18, 2023

Study Record Updates

• Last Update Posted (Actual): April 29, 2024
• Last Update Submitted That Met QC Criteria: April 26, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: IRB-22-297-STW

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No