Protein MetabolismNCT03142737
Are the "ounce-equivalents" in the Protein Foods Groups Really Equivalent?
A study testing Red kidney bean intake, Eggs intake and Peanut butter intake in people with Protein Metabolism, run by University of Arkansas at 1 site in United States.
Trial summary
The investigators will determine effects of different sources of protein on whole-body net protein synthesis and muscle protein synthesis in young healthy participants. Read more about this study
- Who is it for?
- Ages 20 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Protein Metabolism
- What is being tested?
- Red kidney bean intake, Eggs intake and Peanut butter intake
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- 8 May 2017to 15 May 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Men and women, ages 20-40 years
- BMI from 20 to 29.9 kg/m2
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72202
About this study
The investigators will determine effects of different sources of protein on whole-body net protein synthesis and muscle protein synthesis in young healthy participants.
Read the 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.
- Conditions
- Protein Metabolism
- Being tested
- Red kidney bean intake, Eggs intake, Peanut butter intake, Ground beef intake, Intact beef intake
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Red kidney bean intakeOther
Each participant will consume 1/2 cup of cooked red kidney bean
Eggs intakeOther
Each participant will consume 2 cooked large eggs.
Peanut butter intakeOther
Each participant will consume 2 tablespoons of peanut butter.
Ground beef intakeOther
Each participant will consume 2 ounces of 90% lean ground beef.
Intact beef intakeOther
Each participant will consume 2 ounces of intact beef.
| Study group | Role | What they receive |
|---|---|---|
| Red kidney bean intake | Experimental | Subjects will consume 1/2 cup of cooked red kidney bean following diet normalization for 3 days. Receives: Other: Red kidney bean intake |
| Eggs intake | Experimental | Subjects will consume 2 cooked large eggs following diet normalization for 3 days. Receives: Other: Eggs intake |
| Peanut butter intake | Experimental | Subjects will consume 2 tablespoons of peanut butter following diet normalization for 3 days. Receives: Other: Peanut butter intake |
| Ground beef intake | Experimental | Subjects will consume 2 ounces of 90% lean ground beef following diet normalization for 3 days. Receives: Other: Ground beef intake |
| Intact beef intake | Experimental | Subjects will consume 2 ounces of intact beef following diet normalization for 3 days. Receives: Other: Intact beef intake |
What is being measured
The primary outcome is the main question the study is designed to answer.
Net protein synthesis rate
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
Measured: Up to 8.5 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2017
- Study start8 May 2017
- Primary completion6 Mar 2018
- Study completion15 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Protein MetabolismStudies of the same condition, open and under way.
- More trials run by University of ArkansasThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Arkansas
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Robert Wolfe, PhD, Principal investigator, University of Arkansas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03142737
- Sponsor's protocol ID
- 205366
- Status last verified
- Jun 2019
- First submitted
- 2 May 2017
- Last updated
- 3 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Are the "ounce-equivalents" in the Protein Foods Groups Really Equivalent?
- ClinicalTrials.gov ID
- NCT03142737
- Acronym / sponsor ID
- 205366
- Conditions
- Protein Metabolism
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- University of ArkansasUniversity, hospital or other
- Study start
- 8 May 2017 (actual)
- Primary completion
- 6 Mar 2018 (actual)
- Study completion
- 15 May 2019 (actual)
- First posted
- 5 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators will determine effects of different sources of protein on whole-body net protein synthesis and muscle protein synthesis in young healthy participants.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Red kidney bean intake | Experimental | Other: Red kidney bean intakeSubjects will consume 1/2 cup of cooked red kidney bean following diet normalization for 3 days. |
| Eggs intake | Experimental | Other: Eggs intakeSubjects will consume 2 cooked large eggs following diet normalization for 3 days. |
| Peanut butter intake | Experimental | Other: Peanut butter intakeSubjects will consume 2 tablespoons of peanut butter following diet normalization for 3 days. |
| Ground beef intake | Experimental | Other: Ground beef intakeSubjects will consume 2 ounces of 90% lean ground beef following diet normalization for 3 days. |
| Intact beef intake | Experimental | Other: Intact beef intakeSubjects will consume 2 ounces of intact beef following diet normalization for 3 days. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Men and women, ages 20-40 years
- BMI from 20 to 29.9 kg/m2
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Red kidney bean intakeEach participant will consume 1/2 cup of cooked red kidney bean | Other | Red kidney bean intake |
| Eggs intakeEach participant will consume 2 cooked large eggs. | Other | Eggs intake |
| Peanut butter intakeEach participant will consume 2 tablespoons of peanut butter. | Other | Peanut butter intake |
| Ground beef intakeEach participant will consume 2 ounces of 90% lean ground beef. | Other | Ground beef intake |
| Intact beef intakeEach participant will consume 2 ounces of intact beef. | Other | Intact beef intake |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert Wolfe, PhD principal investigator
University of Arkansas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Red kidney bean intake, Eggs intake and Peanut butter intake in people with Protein Metabolism, run by University of Arkansas at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Net protein synthesis rate (time frame: Up to 8.5 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2024.