Protein MetabolismNCT03179462
"Ounce-equivalents" in the Protein Foods Group: Benefits of Quality
A study testing Pork intake, Mixed nuts intake and Tofu intake in people with Protein Metabolism, run by University of Arkansas at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Protein Metabolism
- What is being tested?
- Pork intake, Mixed nuts intake and Tofu intake
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2017to 1 Jul 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Men and women, ages 18-40 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 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
Show all 13Show fewer
- 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
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 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.
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) 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.
- Conditions
- Protein Metabolism
- Being tested
- Pork intake, Mixed nuts intake, Tofu intake
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pork intakeDietary supplement
Each participant will consume 2 ounces of cooked lean pork.
Mixed nuts intakeDietary supplement
Each participant will consume 1 ounce of mixed nuts.
Tofu intakeDietary supplement
Each participant will consume 2 ounces of tofu.
| Study group | Role | What they receive |
|---|---|---|
| Pork intake | Experimental | Subjects will consume 2 ounces of cooked lean pork following diet normalization for 3 days. Receives: Dietary Supplement: Pork intake |
| Mixed nuts intake | Experimental | Subjects will consume 1 ounce of mixed nuts following diet normalization for 3 days. Receives: Dietary Supplement: Mixed nuts intake |
| Tofu intake | Experimental | Subjects will consume 2 ounces of tofu following diet normalization for 3 days. Receives: Dietary Supplement: Tofu 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-hours basal fasted period and 4-hours post-meal period over the 8.5-hour experimental period.
Measured: Change from 4.5 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 posted7 Jun 2017
- Study start1 Dec 2017
- Primary completion6 Jun 2018
- Study completion1 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Arkansas
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03179462
- Sponsor's protocol ID
- 206579
- Status last verified
- Oct 2021
- First submitted
- 5 Jun 2017
- Last updated
- 6 Dec 2021
- Results posted
- Yes, on ClinicalTrials.gov
- 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 6 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Ounce-equivalents" in the Protein Foods Group: Benefits of Quality
- ClinicalTrials.gov ID
- NCT03179462
- Acronym / sponsor ID
- 206579
- Conditions
- Protein Metabolism
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- University of ArkansasUniversity, hospital or other
- Study start
- 1 Dec 2017 (actual)
- Primary completion
- 6 Jun 2018 (actual)
- Study completion
- 1 Jul 2019 (actual)
- First posted
- 7 Jun 2017 (actual)
- Results
- Posted 30 Sep 2021
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 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.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Pork intake | Experimental | Dietary Supplement: Pork intakeSubjects will consume 2 ounces of cooked lean pork following diet normalization for 3 days. |
| Mixed nuts intake | Experimental | Dietary Supplement: Mixed nuts intakeSubjects will consume 1 ounce of mixed nuts following diet normalization for 3 days. |
| Tofu intake | Experimental | Dietary Supplement: Tofu intakeSubjects will consume 2 ounces of tofu following diet normalization for 3 days. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Men and women, ages 18-40 years
- BMI from 20 to 29.9 kg/m2
Key exclusion criteria (13 listed)
- 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
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 |
|---|---|---|
| Pork intakeEach participant will consume 2 ounces of cooked lean pork. | Dietary supplement | Pork intake |
| Mixed nuts intakeEach participant will consume 1 ounce of mixed nuts. | Dietary supplement | Mixed nuts intake |
| Tofu intakeEach participant will consume 2 ounces of tofu. | Dietary supplement | Tofu intake |
Primary outcome
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pork intake, Mixed nuts intake and Tofu 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 13 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 6 Dec 2021. 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?
Yes. Results are posted in the registry (first posted 30 Sep 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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: Change from 4.5 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 6 Dec 2021.