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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pork intake | Experimental | Subjects will consume 2 ounces of cooked lean pork following diet normalization for 3 days. |
|
| Mixed nuts intake | Experimental | Subjects will consume 1 ounce of mixed nuts following diet normalization for 3 days. |
|
| Tofu intake | Experimental | Subjects will consume 2 ounces of tofu following diet normalization for 3 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pork intake | Dietary Supplement | Each participant will consume 2 ounces of cooked lean pork. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Change from 4.5 to 8.5 hours. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Arkansas for Medical Sciences | Little Rock | Arkansas | 72202 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| FG002 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | Mixed Nuts Intake |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Deviation | grams | Change from 4.5 to 8.5 hours. |
|
Adverse events were collected from the time a subject enrolled through their last study visit (e.g. 1 month more or less).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| David D.Church, Ph.D. | University of Arkansas for Medical Sciences | 5015265709 | dchurch@uams.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 28, 2018 | Sep 1, 2021 | Prot_SAP_000.pdf |
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| Mixed nuts intake |
| Dietary Supplement |
Each participant will consume 1 ounce of mixed nuts. |
|
| Tofu intake | Dietary Supplement | Each participant will consume 2 ounces of tofu. |
|
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.
| BG002 | 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. |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| OG002 |
| 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. |
|
|
|
| 0 |
| 9 |
| 0 |
| 9 |
| 0 |
| 9 |
| EG001 | 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. | 0 | 10 | 0 | 10 | 0 | 10 |
| EG002 | 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. | 0 | 8 | 0 | 8 | 0 | 8 |
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