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Effect of an EAA/Whey Composition on Protein Metabolism

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03502941
Recruitment Status : Completed
First Posted : April 19, 2018
Last Update Posted : July 23, 2019
Sponsor:
Information provided by (Responsible Party):
University of Arkansas

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.

Condition or disease Intervention/treatment Phase
Sarcopenia 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 Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention 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: Double (Participant, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Effect of an Essential Amino Acid/Protein Composition on Protein Metabolism
Actual Study Start Date : June 20, 2018
Actual Primary Completion Date : April 9, 2019
Actual Study Completion Date : July 17, 2019

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 Name: 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 Name: 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 Name: Pure Protein, Bayport, NY




Primary Outcome Measures :
  1. Protein anabolism [ Time Frame: Up to 8.5 hours ]
    Changes in net protein balance at whole body

  2. Protein synthesis [ Time Frame: Up to 8.5 hours ]
    Changes in protein synthesis in muscle



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03502941


Locations
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United States, Arkansas
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205
Sponsors and Collaborators
University of Arkansas
Investigators
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Principal Investigator: Arny A Ferrando, Ph.D. University of Arkansas

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of Arkansas
ClinicalTrials.gov Identifier: NCT03502941    
Other Study ID Numbers: 217658
First Posted: April 19, 2018    Key Record Dates
Last Update Posted: July 23, 2019
Last Verified: July 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Sarcopenia
Muscular Atrophy
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Atrophy
Pathological Conditions, Anatomical
Signs and Symptoms