Clinical trial NCT03502941: Effect of an EAA/Whey Composition on Protein Metabolism
Official title: Effect of an Essential Amino Acid/Protein Composition on Protein Metabolism
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sarcopenia
Lead sponsor: University of Arkansas
Sponsor class: OTHER
First posted: 2018-04-19
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention 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)
Primary purpose: BASIC_SCIENCE

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Protein Anabolism
timeFrame: Change from 4.5 to 8.5 hours.
measure: Protein Synthesis
timeFrame: From 4.5 to 8.5 hours.
Secondary outcomes:
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: University of Arkansas for Medical Sciences
state: Arkansas
Study officials:
affiliation: University of Arkansas
name: Arny A Ferrando, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.