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

• Sponsor: University of Arkansas (Other)
• Overall Status: Completed
• CT.gov ID: NCT03179462
• Collaborator: (none)
• Enrollment: 27
• Location: 1
• Arms: 3
• Actual Duration (Months): 19
• Patients Per Site Per Month: 1.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Protein Metabolism	Dietary Supplement: Pork intake; Dietary Supplement: Mixed nuts intake; Dietary Supplement: Tofu intake	N/A

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

• Study Type: Interventional
• Actual Enrollment: 27 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Basic Science
• Official Title: "Ounce-equivalents" in the Protein Foods Group: Benefits of Quality
• Actual Study Start Date: Dec 1, 2017
• Actual Primary Completion Date: Jun 6, 2018
• Actual Study Completion Date: Jul 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Pork intake Subjects will consume 2 ounces of cooked lean pork following diet normalization for 3 days.	Dietary Supplement: Pork intake; 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.	Dietary Supplement: Mixed nuts intake; 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.	Dietary Supplement: Tofu intake; Each participant will consume 2 ounces of tofu.

Outcome Measures

Primary Outcome Measures

1. Net Protein Synthesis Rate [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 40 Years
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Arkansas for Medical Sciences	Little Rock	Arkansas	United States	72202

Sponsors and Collaborators

• University of Arkansas

Investigators

None specified.

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Mar 28, 2018

More Information

Publications

None provided.

• Responsible Party: University of Arkansas
• ClinicalTrials.gov Identifier: NCT03179462
• Other Study ID Numbers: 206579
• First Posted: Jun 7, 2017
• Last Update Posted: Dec 6, 2021
• Last Verified: Oct 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

Participant Flow

Arm/Group Title	Pork Intake	Mixed Nuts Intake	Tofu Intake
Arm/Group Description	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.	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.	Subjects will consume 2 ounces of tofu following diet normalization for 3 days. Tofu intake: Each participant will consume 2 ounces of tofu.
Period Title: Overall Study
STARTED	9	10	8
COMPLETED	8	8	8
NOT COMPLETED	1	2	0

Baseline Characteristics

Arm/Group Title	Pork Intake	Mixed Nuts Intake	Tofu Intake	Total
Arm/Group Description	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.	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.	Subjects will consume 2 ounces of tofu following diet normalization for 3 days. Tofu intake: Each participant will consume 2 ounces of tofu.	Total of all reporting groups
Overall Participants	9	10	8	27
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%	0 0%
Between 18 and 65 years	9 100%	10 100%	8 100%	27 100%
>=65 years	0 0%	0 0%	0 0%	0 0%
Sex: Female, Male (Count of Participants)
Female	4 44.4%	6 60%	4 50%	14 51.9%
Male	5 55.6%	4 40%	4 50%	13 48.1%
Race/Ethnicity, Customized (Count of Participants)
Caucasian	7 77.8%	7 70%	7 87.5%	21 77.8%
Black/African American	2 22.2%	2 20%	1 12.5%	5 18.5%
Asian	0 0%	1 10%	0 0%	1 3.7%
Other Race	0 0%	0 0%	0 0%	0 0%
Hispanic ethnicity	0 0%	1 10%	0 0%	1 3.7%
non-Hispanic ethnicity	9 100%	9 90%	8 100%	26 96.3%

Outcome Measures

1. Primary Outcome

Title	Net Protein Synthesis Rate
Description	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.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Pork Intake	Mixed Nuts Intake	Tofu Intake
Arm/Group Description	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.	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.	Subjects will consume 2 ounces of tofu following diet normalization for 3 days. Tofu intake: Each participant will consume 2 ounces of tofu.
Measure Participants	8	8	8
Mean (Standard Deviation) [grams]	8.65 (1.6)	1.97 (1.04)	5.69 (0.54)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Pork Intake, Mixed Nuts Intake, Tofu Intake
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.05
	Comments
	Method	ANOVA
	Comments

Adverse Events

Time Frame	Adverse events were collected from the time a subject enrolled through their last study visit (e.g. 1 month more or less).
Arm/Group Title	Pork Intake		Mixed Nuts Intake		Tofu Intake
Arm/Group Description	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.		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.		Subjects will consume 2 ounces of tofu following diet normalization for 3 days. Tofu intake: Each participant will consume 2 ounces of tofu.
All Cause Mortality
	Pork Intake		Mixed Nuts Intake		Tofu Intake
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/9 (0%)		0/10 (0%)		0/8 (0%)
Serious Adverse Events
	Pork Intake		Mixed Nuts Intake		Tofu Intake
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/9 (0%)		0/10 (0%)		0/8 (0%)
Other (Not Including Serious) Adverse Events
	Pork Intake		Mixed Nuts Intake		Tofu Intake
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/9 (0%)		0/10 (0%)		0/8 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.