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Ounce-equivalents in the Protein Foods Group: Benefits of Quality

Ounce-equivalents in the Protein Foods Group: Benefits of Quality

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03179462
Enrollment
27
Registered
2017-06-07
Start date
2017-12-01
Completion date
2019-07-01
Last updated
2021-12-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Protein Metabolism

Brief 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.

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.

Interventions

DIETARY_SUPPLEMENTPork intake

Each participant will consume 2 ounces of cooked lean pork.

DIETARY_SUPPLEMENTMixed nuts intake

Each participant will consume 1 ounce of mixed nuts.

DIETARY_SUPPLEMENTTofu intake

Each participant will consume 2 ounces of tofu.

Sponsors

University of Arkansas
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Net Protein Synthesis RateChange 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.

Countries

United States

Participant flow

Participants by arm

ArmCount
Pork Intake
Subjects will consume 2 ounces of cooked lean pork following diet normalization for 3 days. Pork intake: Each participant will consume 2 ounces of cooked lean pork.
9
Mixed Nuts Intake
Subjects will consume 1 ounce of mixed nuts following diet normalization for 3 days. Mixed nuts intake: Each participant will consume 1 ounce of mixed nuts.
10
Tofu Intake
Subjects will consume 2 ounces of tofu following diet normalization for 3 days. Tofu intake: Each participant will consume 2 ounces of tofu.
8
Total27

Withdrawals & dropouts

PeriodReasonFG000FG001FG002
Overall Studyscreening failure120

Baseline characteristics

CharacteristicMixed Nuts IntakeTofu IntakePork IntakeTotal
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
0 Participants0 Participants0 Participants0 Participants
Age, Categorical
Between 18 and 65 years
10 Participants8 Participants9 Participants27 Participants
Race/Ethnicity, Customized
Asian
1 Participants0 Participants0 Participants1 Participants
Race/Ethnicity, Customized
Black/African American
2 Participants1 Participants2 Participants5 Participants
Race/Ethnicity, Customized
Caucasian
7 Participants7 Participants7 Participants21 Participants
Race/Ethnicity, Customized
Hispanic ethnicity
1 Participants0 Participants0 Participants1 Participants
Race/Ethnicity, Customized
non-Hispanic ethnicity
9 Participants8 Participants9 Participants26 Participants
Race/Ethnicity, Customized
Other Race
0 Participants0 Participants0 Participants0 Participants
Sex: Female, Male
Female
6 Participants4 Participants4 Participants14 Participants
Sex: Female, Male
Male
4 Participants4 Participants5 Participants13 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
deaths
Total, all-cause mortality
0 / 90 / 100 / 8
other
Total, other adverse events
0 / 90 / 100 / 8
serious
Total, serious adverse events
0 / 90 / 100 / 8

Outcome results

Primary

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.

Time frame: Change from 4.5 to 8.5 hours.

ArmMeasureValue (MEAN)Dispersion
Pork IntakeNet Protein Synthesis Rate8.65 gramsStandard Deviation 1.6
Mixed Nuts IntakeNet Protein Synthesis Rate1.97 gramsStandard Deviation 1.04
Tofu IntakeNet Protein Synthesis Rate5.69 gramsStandard Deviation 0.54
p-value: <0.05ANOVA

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026