Don't get left behind! The modernized ClinicalTrials.gov is coming. Check it out now.
Say goodbye to ClinicalTrials.gov!
The new site is coming soon - go to the modernized ClinicalTrials.gov
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Effects of Protein Quality on Post-exercise Skeletal Muscle and Whole-body Protein Kinetics During Energy Deficit

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: NCT04004715
Recruitment Status : Completed
First Posted : July 2, 2019
Last Update Posted : March 12, 2020
Sponsor:
Collaborator:
University of Arkansas
Information provided by (Responsible Party):
Stefan Pasiakos, United States Army Research Institute of Environmental Medicine

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
The optimal EAA-containing protein format necessary to maximally stimulate muscle protein synthesis and optimize whole-body net protein balance during caloric deprivation has not been determined. This study will address that gap in knowledge by examining post, whole-body exercise muscle and whole-body protein kinetic responses to ingesting varying EAA-containing protein formats after a 5 day period of negative energy balance. This study will provide the initial evidence to support the development of a recovery-based food product for military combat rations.

Condition or disease Intervention/treatment Phase
Whole-body Protein Balance Muscle Protein Synthesis Dietary Supplement: Essential Amino Acid Enriched Whey Protein Dietary Supplement: Whey Protein Dietary Supplement: Military Ration Entree Not Applicable

Detailed Description:
Ten resistance-trained adults will complete this ~55-d randomized, cross-over study. Participants will participate in three, non-consecutive 5-d controlled energy deficit periods, each separated by a 14-d washout period (i.e., sufficient time to restore nitrogen and metabolic homeostasis after moderate weight loss). Post-exercise (whole-body exercise model) muscle protein synthesis (MPS) and whole-body protein turnover responses to varying EAA-containing protein formats will be determined the morning after completing the 5-d energy deficit.
Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Randomized, partially-blind, cross-over controlled trial
Masking: Double (Participant, Investigator)
Masking Description: All participants and investigators will be blinded to the the beverage treatments. The meal treatment is not blinded.
Primary Purpose: Basic Science
Official Title: Effects of Protein Quality on Post-exercise Skeletal Muscle and Whole-body Protein Kinetics During Negative Energy Balance
Actual Study Start Date : April 25, 2019
Actual Primary Completion Date : December 13, 2019
Actual Study Completion Date : December 13, 2019
Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: Essential Amino Acid Enriched Whey Protein
protein powder formulation that includes whey and free-form essential amino acids
 Dietary Supplement: Essential Amino Acid Enriched Whey Protein
protein powder formulation that includes whey and free-form essential amino acids
Active Comparator: Whey Protein
commercially available whey protein isolate
 Dietary Supplement: Whey Protein
commercially available whey protein isolate
Active Comparator: Military Ration Entree
chili and beans entree; current meal component of the meals ready to eat rations
 Dietary Supplement: Military Ration Entree
chili and beans entree; current meal component of the meals ready to eat rations


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. How fast participants build skeletal muscle after ingesting varying forms of essential amino acid-containing proteins after exercise [ Time Frame: ~4.5 hour measure of muscle protein synthesis ]
    Assessed using stable isotope infusions of phenylalanine.


Secondary Outcome Measures :
  1. How well participants suppress the degradation of body proteins while stimulating the growth of new proteins after ingesting varying forms of essential amino acid-containing proteins after exercise. [ Time Frame: ~4.5 hour measure of whole-body protein balance ]
    Assessed using stable isotope infusions of tyrosine.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Men and women aged 18 - 35 years
  • Body mass index < 30.0 kg/m2
  • Healthy without evidence of chronic illness or musculoskeletal injury as determined by the USARIEM Office of Medical Support and Oversight (OMSO) or home duty station medical support
  • Resistance exercise trained defined by self-report as performing ≥ 2 sessions/wk for previous 6 mo
  • Refrain from taking any nonsteroidal anti-inflammatory drugs (e.g., aspirin, Advil®, Aleve®, Naprosyn®), or any other aspirin-containing product for 10 days before starting and at least 5 days after completing the study
  • Willing to refrain from alcohol, smoking any nicotine product (includes e-cigarettes); vaping, chewing tobacco, caffeine, and dietary supplement use throughout the entire study period
  • Supervisor approval for federal civilian employees and non-HRV active duty military personnel working within the US Army Natick Soldier Systems Center

Exclusion Criteria:

  • Musculoskeletal injuries that compromise exercise capability as determined by the USARIEM or home duty station Office of Medical Support and Oversight (OMSO)
  • Metabolic or cardiovascular abnormalities, gastrointestinal disorders (e.g., kidney disease, diabetes, cardiovascular disease, etc.)
  • Abnormal PT/PTT test or problems with blood clotting
  • History of complications with lidocaine
  • Present condition of alcoholism, anabolic steroids, or other substance abuse issues
  • Blood donation within 8-wk of beginning the study
  • Pregnant, trying to become pregnant, and/or breastfeeding (results of urine pregnancy test or self-report for breastfeeding will be obtained before body composition testing)
  • Unwillingness or inability to consume study diets or foods provided
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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): NCT04004715


Locations
Layout table for location information
United States, Massachusetts
US Army Research Institute of Environmental Medicine
Natick, Massachusetts, United States, 01760
Sponsors and Collaborators
United States Army Research Institute of Environmental Medicine
University of Arkansas
Investigators
Layout table for investigator information
Principal Investigator: Stefan Pasiakos, PhD United States Army Research Institute of Environmental Medicine
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Layout table for additonal information
Responsible Party: Stefan Pasiakos, Nutritional Physiologist, United States Army Research Institute of Environmental Medicine
ClinicalTrials.gov Identifier: NCT04004715    
Other Study ID Numbers: 19-06HC
First Posted: July 2, 2019    Key Record Dates
Last Update Posted: March 12, 2020
Last Verified: March 2020

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No