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

Muscle Protein Synthesis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04004715
• Other study ID #: 19-06HC
• Status: Completed
• Phase: N/A
• Start date: April 25, 2019
• Est. completion date: December 13, 2019

Study information

• Verified date: March 2020
• Source: United States Army Research Institute of Environmental Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: December 13, 2019
• Est. primary completion date: December 13, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Muscle Protein Synthesis
• Whole-body Protein Balance

Intervention

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

Locations

Country	Name	City	State
United States	US Army Research Institute of Environmental Medicine	Natick	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
United States Army Research Institute of Environmental Medicine	University of Arkansas

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	How fast participants build skeletal muscle after ingesting varying forms of essential amino acid-containing proteins after exercise	Assessed using stable isotope infusions of phenylalanine.	~4.5 hour measure of muscle protein synthesis
Secondary	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.	Assessed using stable isotope infusions of tyrosine.	~4.5 hour measure of whole-body protein balance