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Clinical Trials/NCT03502941
NCT03502941CompletedNot Applicable

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

University of Arkansas1 site in 1 country16 target enrollmentStarted: June 20, 2018Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
16
Locations
1
Primary Endpoint
Protein Anabolism

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Primary Purpose
Basic Science
Masking
Double (Participant, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to 50 Years (Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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

Arms & Interventions

A single dose of EAAs/whey

Experimental

Subjects will consume 6.3 g of EAAs/whey in ~12 oz water.

Intervention: 6.3 g of EAAs mixture and whey protein isolate (Dietary Supplement)

A double dose of EAAs/whey

Experimental

Subjects will consume 12.6 g of EAAs/whey in ~12 oz water

Intervention: 12.6 g of EAAs mixture and whey protein isolate (Dietary Supplement)

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.

Intervention: 12.6 g of whey protein isolate (Dietary Supplement)

Outcomes

Primary Outcomes

Protein Anabolism

Time Frame: Change from 4.5 to 8.5 hours.

Changes in net protein balance at whole body (grams)

Protein Synthesis

Time Frame: From 4.5 to 8.5 hours.

Changes in protein synthesis in muscle (percent)

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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