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

Sponsor

United States Army Research Institute of Environmental Medicine (U.S. Fed)

Overall Status

Completed

CT.gov ID

NCT04004715

Collaborator

University of Arkansas (Other)

Enrollment

Location

Arms

7.6

Actual Duration (Months)

1.3

Patients Per Site Per Month

Study Details

Study Description

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	N/A

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

Study Type:

Interventional

Actual Enrollment :

10 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Intervention Model Description:

Randomized, partially-blind, cross-over controlled trialRandomized, 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 :

Apr 25, 2019

Actual Primary Completion Date :

Dec 13, 2019

Actual Study Completion Date :

Dec 13, 2019

Arms and Interventions

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

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

Primary Outcome Measures

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

Secondary Outcome Measures

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. [~4.5 hour measure of whole-body protein balance]
Assessed using stable isotope infusions of tyrosine.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 35 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Locations

	Site	City	State	Country	Postal Code
1	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

Principal Investigator: Stefan Pasiakos, PhD, United States Army Research Institute of Environmental Medicine

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

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:

Jul 2, 2019

Last Update Posted:

Mar 12, 2020

Last Verified:

Mar 1, 2020

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Mar 12, 2020