AzTrials
AzTrials

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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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

Other trials in United States

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.

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 groups in NCT03179462
Study groupRoleWhat they receive
Pork intakeExperimentalSubjects will consume 2 ounces of cooked lean pork following diet normalization for 3 days.
Receives: Dietary Supplement: Pork intake
Mixed nuts intakeExperimentalSubjects will consume 1 ounce of mixed nuts following diet normalization for 3 days.
Receives: Dietary Supplement: Mixed nuts intake
Tofu intakeExperimentalSubjects 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.

  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.

    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.

  1. First posted7 Jun 2017
  2. Study start1 Dec 2017
  3. Primary completion6 Jun 2018
  4. Study completion1 Jul 2019

Resources

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)
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
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in