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OpenTrials
Completed

NCT Number: NCT03502941

Effect of an EAA/Whey Composition on Protein Metabolism

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.

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Key information

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

6.3 g of EAAs mixture and whey protein isolate

Dietary Supplement

A single dose of the mixture of EAAs/whey

Other names: Essential Blends, Fairbanks, Alaska (AK), and Pure Protein, Bayport, New York (NY)

12.6 g of EAAs mixture and whey protein isolate

Dietary Supplement

A double dose of the mixture of EAAs/whey

Other names: Essential Blends, Fairbanks, AK, and Pure Protein, Bayport, NY

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

Other names: Pure Protein, Bayport, NY

Primary outcomes

  1. Protein Anabolism

    Time frame: Change from 4.5 to 8.5 hours.

    Changes in net protein balance at whole body (grams)

  2. Protein Synthesis

    Time frame: From 4.5 to 8.5 hours.

    Changes in protein synthesis in muscle (percent)

Sponsors and collaborators

Lead sponsor

University of Arkansas

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Apr 19, 2018
Registry last updated
Nov 2, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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