"Ounce-equivalents" in the Protein Foods Group: Benefits of Quality
1 other identifier
interventional
27
1 country
1
Brief Summary
The investigators will examine the effects of a given amount of a protein food source such as pork, mixed nuts, and tofu on anabolic response at the whole body and muscle levels in young, healthy adults.
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 Dec 2017
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
First Submitted
Initial submission to the registry
June 5, 2017
CompletedFirst Posted
Study publicly available on registry
June 7, 2017
CompletedStudy Start
First participant enrolled
December 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 6, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2019
CompletedResults Posted
Study results publicly available
September 30, 2021
CompletedDecember 6, 2021
October 1, 2021
6 months
June 5, 2017
September 1, 2021
October 26, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Net Protein Synthesis Rate
Net protein synthesis rate is determined in the 4.5-hours basal fasted period and 4-hours post-meal period over the 8.5-hour experimental period.
Change from 4.5 to 8.5 hours.
Study Arms (3)
Pork intake
EXPERIMENTALSubjects will consume 2 ounces of cooked lean pork following diet normalization for 3 days.
Mixed nuts intake
EXPERIMENTALSubjects will consume 1 ounce of mixed nuts following diet normalization for 3 days.
Tofu intake
EXPERIMENTALSubjects will consume 2 ounces of tofu following diet normalization for 3 days.
Interventions
Each participant will consume 1 ounce of mixed nuts.
Eligibility Criteria
You may qualify if:
- Men and women, ages 18-40 years
- BMI from 20 to 29.9 kg/m2
You may not qualify if:
- Current diagnosis of diabetes
- History of malignancy in the 6 months prior to enrollment
- History of a chronic inflammatory condition or other chronic diseases (Lupus, HIV/AIDS, etc)
- History of weight reduction surgery (Lapband, gastric sleeve, etc.)
- Pregnant females
- Subjects who do not or will not eat animal proteins
- Subjects allergic to pork, tree or peanuts, or soybeans
- Subjects who cannot refrain from consuming protein or amino acid supplements during their participation in this study
- Subjects who report regular resistance training exercise \> one per week
- Hemoglobin \< 9.5 g/dL at the screening visit
- Platelets \< 250,000 at the screening visit
- Concomitant use of corticosteroids (ingestion, injection or transdermal)
- Any other disease or condition that would place the subject at increased risk of harm if they were to participate, at the discretion of the study physician
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72202, United States
Results Point of Contact
- Title
- David D.Church, Ph.D.
- Organization
- University of Arkansas for Medical Sciences
Publication Agreements
- PI is Sponsor Employee
- Yes
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 5, 2017
First Posted
June 7, 2017
Study Start
December 1, 2017
Primary Completion
June 6, 2018
Study Completion
July 1, 2019
Last Updated
December 6, 2021
Results First Posted
September 30, 2021
Record last verified: 2021-10
Data Sharing
- IPD Sharing
- Will not share