Effect of an EAA/Whey Composition on Protein Metabolism
Primary Purpose
Sarcopenia
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
6.3 g of EAAs mixture and whey protein isolate
12.6 g of EAAs mixture and whey protein isolate
12.6 g of whey protein isolate
Sponsored by
About this trial
This is an interventional basic science trial for Sarcopenia
Eligibility Criteria
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
Sites / Locations
- University of Arkansas for Medical Sciences
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
A single dose of EAAs/whey
A double dose of EAAs/whey
Whey protein alone
Arm Description
Subjects will consume 6.3 g of EAAs/whey in ~12 oz water.
Subjects will consume 12.6 g of EAAs/whey in ~12 oz water
Subjects will consume 12.6 g of whey protein isolate which is an equal amount to the double dose of EAAs/whey.
Outcomes
Primary Outcome Measures
Protein Anabolism
Changes in net protein balance at whole body (grams)
Protein Synthesis
Changes in protein synthesis in muscle (percent)
Secondary Outcome Measures
Full Information
NCT ID
NCT03502941
First Posted
March 30, 2018
Last Updated
November 1, 2021
Sponsor
University of Arkansas
1. Study Identification
Unique Protocol Identification Number
NCT03502941
Brief Title
Effect of an EAA/Whey Composition on Protein Metabolism
Official Title
Effect of an Essential Amino Acid/Protein Composition on Protein Metabolism
Study Type
Interventional
2. Study Status
Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
June 20, 2018 (Actual)
Primary Completion Date
April 9, 2019 (Actual)
Study Completion Date
July 17, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Arkansas
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sarcopenia
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
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)
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
16 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A single dose of EAAs/whey
Arm Type
Experimental
Arm Description
Subjects will consume 6.3 g of EAAs/whey in ~12 oz water.
Arm Title
A double dose of EAAs/whey
Arm Type
Experimental
Arm Description
Subjects will consume 12.6 g of EAAs/whey in ~12 oz water
Arm Title
Whey protein alone
Arm Type
Experimental
Arm Description
Subjects will consume 12.6 g of whey protein isolate which is an equal amount to the double dose of EAAs/whey.
Intervention Type
Dietary Supplement
Intervention Name(s)
6.3 g of EAAs mixture and whey protein isolate
Other Intervention Name(s)
Essential Blends, Fairbanks, Alaska (AK), and Pure Protein, Bayport, New York (NY)
Intervention Description
A single dose of the mixture of EAAs/whey
Intervention Type
Dietary Supplement
Intervention Name(s)
12.6 g of EAAs mixture and whey protein isolate
Other Intervention Name(s)
Essential Blends, Fairbanks, AK, and Pure Protein, Bayport, NY
Intervention Description
A double dose of the mixture of EAAs/whey
Intervention Type
Dietary Supplement
Intervention Name(s)
12.6 g of whey protein isolate
Other Intervention Name(s)
Pure Protein, Bayport, NY
Intervention Description
Whey protein isolate alone, which is an equal amount to the double dose of the mixture of EAAs/whey
Primary Outcome Measure Information:
Title
Protein Anabolism
Description
Changes in net protein balance at whole body (grams)
Time Frame
Change from 4.5 to 8.5 hours.
Title
Protein Synthesis
Description
Changes in protein synthesis in muscle (percent)
Time Frame
From 4.5 to 8.5 hours.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Arny A Ferrando, Ph.D.
Organizational Affiliation
University of Arkansas
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Arkansas for Medical Sciences
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
32041644
Citation
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.
Results Reference
derived
Learn more about this trial
Effect of an EAA/Whey Composition on Protein Metabolism
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