- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03142737
Are the "ounce-equivalents" in the Protein Foods Groups Really Equivalent?
August 29, 2024 updated by: University of Arkansas
The investigators will determine effects of different sources of protein on whole-body net protein synthesis and muscle protein synthesis in young healthy participants.
Study Overview
Status
Completed
Conditions
Detailed Description
Over the past 35 years the United States Department of Agriculture (USDA) Dietary Guidelines for Americans (DGAs) has sought to translate recommendations on nutrient requirements (i.e., Recommended Dietary Allowances (RDAs) from the Food and Nutrition Board of the Institute of Medicine (IOM) into practical nutritional advice for the American public.
Over the same time interval in which the Dietary Guidelines have existed the occurrence of nutrition-related health problems in the United States has escalated dramatically, showing that the population of obesity in U.S. has reached to a total of 35.8%.
In addition, the lack of appropriate focus on protein nutrition is a major shortcoming of the DGAs.
Not only is the amount of protein not a major focus, but also absolutely no mention is made of protein quality.
Protein quality refers to the amount, profile, and true ileal digestibility of the essential amino acids (EAAs) in the protein.
However, the concept of protein quality is not new, as the Protein Digestible Corrected Amino Acid Score was published by the Food and Agriculture Organization of the World Health Organization in 1993.
Although animal protein (and beef specifically) has much higher the Digestible Indispensable Amino Acid Score (DIAAS) than plant proteins, often by as much as two fold, DIAAS has not taken account of the importance of the amount and profile of EAAs in individuals proteins.
Moreover, the misrepresentation of the equivalencies of various food sources of protein in MyPlate raises the question of the process by which this occurred, and how can the process be influenced to more accurately reflect that high quality of animal proteins, including beef?
Therefore, we propose to make these measurements in response to intake of "equivalent "(according to MyPlate) amounts of beef, kidney beans, eggs and peanut butter.
Demonstration that the functional responses to these varied sources of protein coincide with the predictions from the USDA nutrient data base and calculation of the DIAAS will provide needed support to redefine "ounce equivalents" of protein food sources according to those data bases for all animal and plant sources of protein.
Study Type
Interventional
Enrollment (Actual)
45
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Arkansas
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Little Rock, Arkansas, United States, 72202
- University of Arkansas for Medical Sciences
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 40 years (Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Men and women, ages 20-40 years
- BMI from 20 to 29.9 kg/m2
Exclusion Criteria:
- Current diagnosis of diabetes
- History of malignancy in the 6 months prior to enrollment
- History of gastrointestinal bypass surgery
- History of a chronic inflammatory condition or other chronic diseases (Lupus, HIV/AIDS, etc)
- Female subjects who are currently pregnant
- Subjects who are unable to eat animal protein
- Subjects who are unable to stop eating protein or Amino Acid (AA) supplements during the participation
- Subjects who report regular resistance training (more than twice per week)
- Subjects who have concomitant use of corticosteroids (ingestion, injection or transdermal)
- Hemoglobin less than 9.5 g/dL at the screening visit
- Platelets less than 250,000 at the screening visit.
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Red kidney bean intake
Subjects will consume 1/2 cup of cooked red kidney bean following diet normalization for 3 days.
|
Each participant will consume 1/2 cup of cooked red kidney bean
|
|
Experimental: Eggs intake
Subjects will consume 2 cooked large eggs following diet normalization for 3 days.
|
Each participant will consume 2 cooked large eggs.
|
|
Experimental: Peanut butter intake
Subjects will consume 2 tablespoons of peanut butter following diet normalization for 3 days.
|
Each participant will consume 2 tablespoons of peanut butter.
|
|
Experimental: Ground beef intake
Subjects will consume 2 ounces of 90% lean ground beef following diet normalization for 3 days.
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Each participant will consume 2 ounces of 90% lean ground beef.
|
|
Experimental: Intact beef intake
Subjects will consume 2 ounces of intact beef following diet normalization for 3 days.
|
Each participant will consume 2 ounces of intact beef.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Net protein synthesis rate
Time Frame: Up to 8.5 hours
|
Net protein synthesis rate is determined in the 4.5-hour basal fasted period and 4-hous post-meal period over the 8.5-hour experimental period
|
Up to 8.5 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Robert Wolfe, PhD, University of Arkansas
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 8, 2017
Primary Completion (Actual)
March 6, 2018
Study Completion (Actual)
May 15, 2019
Study Registration Dates
First Submitted
May 2, 2017
First Submitted That Met QC Criteria
May 4, 2017
First Posted (Actual)
May 5, 2017
Study Record Updates
Last Update Posted (Actual)
September 3, 2024
Last Update Submitted That Met QC Criteria
August 29, 2024
Last Verified
June 1, 2019
More Information
Terms related to this study
Other Study ID Numbers
- 205366
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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