Effect of an EAA/Whey Composition on Protein Metabolism

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Effect of an Essential Amino Acid/Protein Composition on Protein Metabolism

Conditions
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Sarcopenia

Intervention / Treatment
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* Dietary Supplement: 6.3 g of EAAs mixture and whey protein isolate
* Dietary Supplement: 12.6 g of EAAs mixture and whey protein isolate
* Dietary Supplement: 12.6 g of whey protein isolate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: BMI between 20 and 30 kg/m^2 Exclusion Criteria: Current diagnosis of diabetes History of malignancy in the 6 months prior to enrollment Weight reduction surgery Chronic inflammatory (Lupus, HIV/AIDS) Currently pregnant females Unable to eat dairy protein Unable to stop eating protein or Amino Acid (AA) supplements during the participation Regular resistance training (> once per week) Concomitant use of corticosteroids (ingestion, injection or transdermal) Subjects who cannot safely stop using aspirin for 7 days prior to muscle biopsies Hemoglobin less than 9.5 g/dL, and platelets less than 150,000 at the screening visit Any other disease or condition placing the subject at increased risk of harm if they were to participate, at the discretion of the study physician

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: 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)
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A single dose of EAAs/whey<br>Subjects will consume 6.3 g of EAAs/whey in  12 oz water. | Dietary Supplement: 6.3 g of EAAs mixture and whey protein isolate<br>* A single dose of the mixture of EAAs/whey<br>* Other names: Essential Blends, Fairbanks, Alaska (AK), and Pure Protein, Bayport, New York (NY);|
| Experimental: A double dose of EAAs/whey<br>Subjects will consume 12.6 g of EAAs/whey in  12 oz water | Dietary Supplement: 12.6 g of EAAs mixture and whey protein isolate<br>* A double dose of the mixture of EAAs/whey<br>* Other names: Essential Blends, Fairbanks, AK, and Pure Protein, Bayport, NY;|
| Experimental: Whey protein alone<br>Subjects will consume 12.6 g of whey protein isolate which is an equal amount to the double dose of EAAs/whey. | Dietary Supplement: 12.6 g of whey protein isolate<br>* Whey protein isolate alone, which is an equal amount to the double dose of the mixture of EAAs/whey<br>* Other names: Pure Protein, Bayport, NY;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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. |