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Sarcopenia, a progressive loss of muscle mass, strength and function, is an inevitable natural process of aging. While it may be impossible to completely reverse the progress of sarcopenia, it is well established that intake of dietary protein through essential amino acids (EAAs) and whey protein increases anabolic response. The current study will test if a specially formulated mixture of EAAs and whey protein can maximally stimulate anabolic responses at the levels of whole body and muscle compared to whey protein alone.
The product composition is protected by intellectual property. It contains a combination of ingredients designed to stimulate anabolic responses at whole body and muscle and to ultimately induce long-term improvements in muscle function and size. EAAs are the only dietary macronutrients that are required for survival. They are "essential" because the body cannot produce them. There are 9 dietary EAAs while there are 11 dietary non-essential amino acids that are not required in the diet because they can be produced in the body. The composition is based on a blend of 8 of the 9 EAAs. In addition to being the "active" components of dietary protein, EAAs also have the advantage over intact protein including whey protein because free EAAs are absorbed from the intestine more quickly and more completely than amino acids contained in protein, which requires digestion before absorption indicating that intact protein is relatively slowly absorbed. Therefore, the combination of free EAAs and intact protein give not only an immediate response (from the free EAAs) but also a prolonged response (from the intact protein) over time by the slower digestion. The idea of combining a specific formulation of EAAs with an intact protein to obtain both an immediate as well as a more sustained response in protein anabolism is novel. Investigators propose that consumption of the EAA/protein composition will stimulate the net protein balance at the whole body level in a dose-dependent manner. The investigators further propose that the magnitude of increase in the net protein balance will be greater than induced by the consumption of the same amount of whey protein isolate.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A single dose of EAAs/whey | Experimental | Subjects will consume 6.3 g of EAAs/whey in ~12 oz water. |
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| A double dose of EAAs/whey | Experimental | Subjects will consume 12.6 g of EAAs/whey in ~12 oz water |
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| Whey protein alone | Experimental | Subjects will consume 12.6 g of whey protein isolate which is an equal amount to the double dose of EAAs/whey. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 6.3 g of EAAs mixture and whey protein isolate | Dietary Supplement | A single dose of the mixture of EAAs/whey |
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| Measure | Description | Time Frame |
|---|---|---|
| Protein Anabolism | Changes in net protein balance at whole body (grams) | Change from 4.5 to 8.5 hours. |
| Protein Synthesis | Changes in protein synthesis in muscle (percent) | From 4.5 to 8.5 hours. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Arny A Ferrando, Ph.D. | University of Arkansas | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Arkansas for Medical Sciences | Little Rock | Arkansas | 72205 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32041644 | Derived | Park S, Church DD, Azhar G, Schutzler SE, Ferrando AA, Wolfe RR. Anabolic response to essential amino acid plus whey protein composition is greater than whey protein alone in young healthy adults. J Int Soc Sports Nutr. 2020 Feb 10;17(1):9. doi: 10.1186/s12970-020-0340-5. |
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Of the 16 subjects enrolled, 8 were randomized into an arm that has a crossover component of two study interventions. The other 8 subjects were randomized into a control arm that had only one intervention.
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| ID | Title | Description |
|---|---|---|
| FG000 | EAAs/Whey (6.3 g Dose First, Then 12.6g) | Subjects will consume 6.3 g of EAAs/whey in ~12 oz water at their first intervention visit, then 12.6 g of the same product at their second intervention visit. |
| FG001 | EAAs/Whey (12.6g First, Then 6.3g) | Subjects will consume 12.6 g of EAAs/whey in ~12 oz water at their first intervention visit, then 6.3 g of the same product at their second intervention visit. |
| FG002 | Whey Protein Alone | Subjects will consume 12.6 g of whey protein isolate which is an equal amount to the double dose of EAAs/whey. 12.6 g of whey protein isolate: Whey protein isolate alone, which is an equal amount to the double dose of the mixture of EAAs/whey |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | EAAs/Whey: 6.3g First, Then 12.6g | Subjects will consume 6.3 g of EAAs/whey in ~12 oz water on 1 day. Then washout at least 5 days. Then consume 12.6 g of study product at another visit. |
| BG001 | EAAs/Whey: 12.6g First, Then 6.3g |
| 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 | Protein Anabolism | Changes in net protein balance at whole body (grams) | Posted | Mean | Standard Deviation | grams | Change from 4.5 to 8.5 hours. |
|
From enrollment to last study visit, an average of 1 month
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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 | A Single Dose of EAAs/Whey | Subjects will consume 6.3 g of EAAs/whey in ~12 oz water. 6.3 g of EAAs mixture and whey protein isolate: A single dose of the mixture of EAAs/whey |
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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 19, 2018 | Sep 1, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D055948 | Sarcopenia |
| ID | Term |
|---|---|
| D009133 | Muscular Atrophy |
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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Arm 1 and 2: Crossover design for two different doses of the product (~6.3 and 12.6 g of active components).
Arm 3: Parallel comparison equal to the double dose of whey protein isolate (12.6 g)
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| 12.6 g of EAAs mixture and whey protein isolate | Dietary Supplement | A double dose of the mixture of EAAs/whey |
|
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| 12.6 g of whey protein isolate | Dietary Supplement | Whey protein isolate alone, which is an equal amount to the double dose of the mixture of EAAs/whey |
|
|
Subjects will consume 12.6 g of EAAs/whey in ~12 oz water on 1 day. Then washout at least 5 days. Then consume 6.3 g of study product at another visit.
| BG002 | Whey Protein Alone | Subjects will consume 12.6 g of whey protein isolate which is an equal amount to the double dose of EAAs/whey. |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
Subjects will consume 12.6 g of whey protein isolate which is an equal amount to the double dose of EAAs/whey. 12.6 g of whey protein isolate: Whey protein isolate alone, which is an equal amount to the double dose of the mixture of EAAs/whey |
|
|
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| Primary | Protein Synthesis | Changes in protein synthesis in muscle (percent) | Posted | Mean | Standard Deviation | percent change | From 4.5 to 8.5 hours. |
|
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|
|
| 0 |
| 8 |
| 0 |
| 8 |
| 0 |
| 8 |
| EG001 | A Double Dose of EAAs/Whey | Subjects will consume 12.6 g of EAAs/whey in ~12 oz water 12.6 g of EAAs mixture and whey protein isolate: A double dose of the mixture of EAAs/whey | 0 | 8 | 0 | 8 | 0 | 8 |
| EG002 | Whey Protein Alone | Subjects will consume 12.6 g of whey protein isolate which is an equal amount to the double dose of EAAs/whey. 12.6 g of whey protein isolate: Whey protein isolate alone, which is an equal amount to the double dose of the mixture of EAAs/whey | 0 | 8 | 0 | 8 | 0 | 8 |
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| D001284 | Atrophy |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |