Effect of an EAA/Whey Composition on Protein Metabolism

Effect of an Essential Amino Acid/Protein 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.

Study Overview

• Status: Completed
• Conditions: Sarcopenia
• Intervention / Treatment: 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

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 Type: Interventional
• Enrollment (Actual): 16
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arkansas
    • Little Rock, Arkansas, United States, 72205
      • University of Arkansas for Medical Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: A single dose of EAAs/whey; 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; A single dose of the mixture of EAAs/whey; Other Names: Essential Blends, Fairbanks, Alaska (AK), and Pure Protein, Bayport, New York (NY)
Experimental: A double dose of EAAs/whey; 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; A double dose of the mixture of EAAs/whey; Other Names: Essential Blends, Fairbanks, AK, and Pure Protein, Bayport, NY
Experimental: Whey protein alone; 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; 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

What is the study measuring?

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.

Collaborators and Investigators

• Sponsor: University of Arkansas

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 20, 2018
• Primary Completion (Actual): April 9, 2019
• Study Completion (Actual): July 17, 2019

Study Registration Dates

• First Submitted: March 30, 2018
• First Submitted That Met QC Criteria: April 17, 2018
• First Posted (Actual): April 19, 2018

Study Record Updates

• Last Update Posted (Actual): November 2, 2021
• Last Update Submitted That Met QC Criteria: November 1, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Neuromuscular Manifestations; Pathological Conditions, Anatomical; Muscular Atrophy; Atrophy; Sarcopenia
• Other Study ID Numbers: 217658

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No