Longitudinal Examination of Metabolic and Behavioral Correlates of Protein Sources

Health Behavior Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06089460
• Other study ID #: IRB-22-297-STW
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 1, 2023
• Est. completion date: December 1, 2024

Study information

• Verified date: April 2024
• Source: Oklahoma State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. completion date: December 1, 2024
• Est. primary completion date: February 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Health Behavior

Intervention

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

Locations

Country	Name	City	State
United States	Oklahoma State University	Stillwater	Oklahoma

Sponsors (1)

Lead Sponsor	Collaborator
Oklahoma State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Body weight	In kilograms	Baseline (week 0), T1 (week 4), T2 (week 8)
Secondary	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)
Secondary	Fasting blood glucose	In mg/dL	Baseline (week 0), T1 (week 4), T2 (week 8)
Secondary	Yale Food Addiction Scale	Continuous score = 0-7 (higher = more symptoms of food addiction)	Baseline (week 0), T1 (week 4), T2 (week 8)
Secondary	Skin carotenoids		Baseline (week 0), T1 (week 4), T2 (week 8)
Secondary	Blood pressure	Systolic and diastolic (mmHg)	Baseline (week 0), T1 (week 4), T2 (week 8)
Secondary	Dietary patterns (3-day diet records)		Baseline (week 0), T1 (week 4), T2 (week 8)
Secondary	Behavioral Activation Scale Reward Responsiveness	Score ranges 5-20, higher scores indicate greater reward responsiveness	Baseline (week 0), T1 (week 4), T2 (week 8)
Secondary	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)
Secondary	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)