- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03179462
"Ounce-equivalents" in the Protein Foods Group: Benefits of Quality
October 26, 2021 updated by: University of Arkansas
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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) from the Food and Nutrition Board of the Institute of Medicine (IOM) into practical nutritional advice for the American public.
Although the DGAs are intended to incorporate additional scientific evidence, 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, absolutely no mention is made of protein quality.
In general, animal proteins have much higher the Digestible Indispensable Amino Acid Scores (DIAASs) than plant proteins, often by as much as two fold.
Account has not been taken of DIAAS, or even the general concept of the importance of the amount and profile of essential amino acids in individual proteins, in formulation of MyPlate or the scientific report of the DGAs Committee.
This is because a classification does not apply to most plant proteins, despite the fact that in the IOM report stating the Recommended Dietary Allowance for protein it is specified that this refers to "high quality protein.
To help the consumer meet protein needs while achieving the goal of varied protein food sources, the DGAs Committee published "ounce equivalents" in the protein foods group.
It is stated among other equivalents cited, that 1 ounce (oz.) of meat is equivalent to 1 tablespoon (Tbsp.) of peanut butter and 1/4 cup (0.5 ounces) of cooked kidney beans.
But are they really equivalent?
This indicates that the "ounce equivalents" of protein foods in MyPlate are not equivalent in any parameter that might be used to assess nutritional benefit, and demonstrates that the bias against animal proteins is in the Dietary Guidelines.
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?
Therefore, developing convincing data to correct the MyPlate "ounce equivalents" of protein foods is an achievable goal.
In general, dietary protein intake serves many physiological roles, but the most prominent is the maintenance or gain of body protein.
This is accomplished by stimulation of protein synthesis, the inhibition of protein breakdown, or a combination.
Thus, the functional response to consumption of a given amount of a protein food source is best assessed by quantifying the rates of protein synthesis and breakdown at the whole body level as well as at the muscle level in order to calculate the anabolic response.
The investigators propose to make these measurements in response to intake of "equivalent "(according to MyPlate) amounts of pork, mixed nuts and tofu.
Moreover, the functional responses to these varied sources of protein we will examine 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)
27
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
-
-
Arkansas
-
Little Rock, Arkansas, United States, 72202
- University of Arkansas for Medical Sciences
-
-
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
18 years to 40 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Men and women, ages 18-40 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 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
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: Pork intake
Subjects will consume 2 ounces of cooked lean pork following diet normalization for 3 days.
|
Each participant will consume 2 ounces of cooked lean pork.
|
|
Experimental: Mixed nuts intake
Subjects will consume 1 ounce of mixed nuts following diet normalization for 3 days.
|
Each participant will consume 1 ounce of mixed nuts.
|
|
Experimental: Tofu intake
Subjects will consume 2 ounces of tofu following diet normalization for 3 days.
|
Each participant will consume 2 ounces of tofu.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Net Protein Synthesis Rate
Time Frame: Change from 4.5 to 8.5 hours.
|
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.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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)
December 1, 2017
Primary Completion (Actual)
June 6, 2018
Study Completion (Actual)
July 1, 2019
Study Registration Dates
First Submitted
June 5, 2017
First Submitted That Met QC Criteria
June 5, 2017
First Posted (Actual)
June 7, 2017
Study Record Updates
Last Update Posted (Actual)
December 6, 2021
Last Update Submitted That Met QC Criteria
October 26, 2021
Last Verified
October 1, 2021
More Information
Terms related to this study
Other Study ID Numbers
- 206579
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
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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