Longitudinal Examination of Metabolic and Behavioral Correlates of Protein Sources
1 other identifier
interventional
30
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jan 2023
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2023
CompletedFirst Submitted
Initial submission to the registry
July 28, 2023
CompletedFirst Posted
Study publicly available on registry
October 18, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2024
CompletedApril 29, 2024
April 1, 2024
1.1 years
July 28, 2023
April 26, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Body weight
In kilograms
Baseline (week 0), T1 (week 4), T2 (week 8)
Secondary Outcomes (9)
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)
Skin carotenoids
Baseline (week 0), T1 (week 4), T2 (week 8)
Blood pressure
Baseline (week 0), T1 (week 4), T2 (week 8)
- +4 more secondary outcomes
Study Arms (3)
Beef
EXPERIMENTALIndividuals 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
EXPERIMENTALIndividuals 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.
Beans/legumes
EXPERIMENTALIndividuals 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.
Interventions
Fresh, locally-sourced, grass-fed, grass-finished ground beef sufficient to meet protein needs based on body weight for 8 weeks
Commercially-available and purchased meat analogue sufficient to meet protein needs based on body weight for 8 weeks
Canned beans/legumes sufficient to meet protein needs based on body weight for 8 weeks
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Medical condition which precludes consumption of specific foods or whole food groups
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Oklahoma State University
Stillwater, Oklahoma, 74078, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 28, 2023
First Posted
October 18, 2023
Study Start
January 1, 2023
Primary Completion
February 1, 2024
Study Completion
December 1, 2024
Last Updated
April 29, 2024
Record last verified: 2024-04