Effect of an EAA/Whey Composition on Protein Metabolism

Sarcopenia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03502941
• Other study ID #: 217658
• Status: Completed
• Phase: N/A
• Start date: June 20, 2018
• Est. completion date: July 17, 2019

Study information

• Verified date: November 2021
• Source: University of Arkansas
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: July 17, 2019
• Est. primary completion date: April 9, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Sarcopenia

Intervention

Dietary Supplement:
• 6.3 g of EAAs mixture and whey protein isolate
A single dose of the mixture of EAAs/whey
• 12.6 g of EAAs mixture and whey protein isolate
A double dose of the mixture 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

Locations

Country	Name	City	State
United States	University of Arkansas for Medical Sciences	Little Rock	Arkansas

Sponsors (1)

Lead Sponsor	Collaborator
University of Arkansas

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Protein Anabolism	Changes in net protein balance at whole body (grams)	Change from 4.5 to 8.5 hours.
Primary	Protein Synthesis	Changes in protein synthesis in muscle (percent)	From 4.5 to 8.5 hours.