Effect of an EAA/Whey Composition on Protein Metabolism

NCT03502941 | Completed Results

• 1 other identifier: 217658
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Sarcopenia

Outcome Measures

Primary Outcomes (2)

• 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.

Study Arms (3)

A single dose of EAAs/whey

EXPERIMENTAL

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 double dose of EAAs/whey

EXPERIMENTAL

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

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.

Dietary Supplement: 12.6 g of whey protein isolate

Interventions

6.3 g of EAAs mixture and whey protein isolate DIETARY_SUPPLEMENT

A single dose of the mixture of EAAs/whey

Also known as: Essential Blends, Fairbanks, Alaska (AK), and Pure Protein, Bayport, New York (NY)

A single dose of EAAs/whey

12.6 g of EAAs mixture and whey protein isolate DIETARY_SUPPLEMENT

A double dose of the mixture of EAAs/whey

Also known as: Essential Blends, Fairbanks, AK, and Pure Protein, Bayport, NY

A double dose of EAAs/whey

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

Also known as: Pure Protein, Bayport, NY

Whey protein alone

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• BMI between 20 and 30 kg/m\^2

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Arkansas: lead

Study Sites (1)

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

Location

Related Publications (1)

• 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.

  PMID: 32041644 DERIVED

MeSH Terms

Conditions

Sarcopenia

Condition Hierarchy (Ancestors)

Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Results Point of Contact

• Title: David D.Church, Ph.D.
• Organization: University of Arkansas for Medical Sciences

dchurch@uams.edu

5015265709

Study Officials

• Arny A Ferrando, Ph.D.

  University of Arkansas

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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)

Study Record Dates

• First Submitted: March 30, 2018
• First Posted: April 19, 2018
• Study Start: June 20, 2018
• Primary Completion: April 9, 2019
• Study Completion: July 17, 2019
• Last Updated: November 2, 2021
• Results First Posted: November 2, 2021

Record last verified: 2021-11

Locations

US (1)