Longitudinal Examination of Metabolic and Behavioral Correlates of Protein Sources

Sponsor

Oklahoma State University (Other)

Overall Status

Recruiting

CT.gov ID

NCT06089460

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

2.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Health Behavior	Other: Beef Other: Meat analogue Other: Beans/legumes	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Jan 1, 2023

Anticipated Primary Completion Date :

Dec 31, 2023

Anticipated Study Completion Date :

Dec 31, 2023

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Body weight [Baseline (week 0), T1 (week 4), T2 (week 8)]

Secondary Outcome Measures

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 [Baseline (week 0), T1 (week 4), T2 (week 8)]
Continuous score = 0-7 (higher = more symptoms of food addiction)
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 [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)]
Salivary Cortisol [Baseline (week 0), T1 (week 4), T2 (week 8)]
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 55 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Oklahoma State University	Stillwater	Oklahoma	United States	74078

Sponsors and Collaborators

Oklahoma State University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Oklahoma State University

ClinicalTrials.gov Identifier:

NCT06089460

Other Study ID Numbers:

IRB-22-297-STW

First Posted:

Oct 18, 2023

Last Update Posted:

Oct 18, 2023

Last Verified:

Oct 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Oct 18, 2023