Essential Amino Acids and Protein Kinetics During Caloric Deprivation

NCT ID: NCT03372928

Last Updated: 2020-11-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-09-01
• Study Completion Date: 2019-03-20

Brief Summary

The amount of essential amino acids (EAA) 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 the resting and post-exercise muscle and whole-body protein kinetic responses to ingesting varying amounts of EAA 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.

Detailed Description

Short-term negative energy balance downregulates muscle protein synthesis and upregulates whole-body proteolysis and amino acid (AA) oxidation, thereby increasing nitrogen excretion and exacerbating whole-body and skeletal muscle protein loss. Consumption of quality proteins high in essential amino acid (EAA) content may attenuate protein loss during energy deficit by restoring whole-body and skeletal muscle anabolic potential to that observed in a eucaloric state. During energy balance, muscle protein synthesis appears to be maximally stimulated after consuming 15 g of EAA at rest and after conventional resistance-type exercise. In response to a short-term energy deficit that downregulated basal muscle protein synthesis by as much as 27%, consuming 15 g (~7.5 g EAA) and 30 g (~15 g EAA) of whey protein after a bout of resistance exercise restored muscle protein synthesis rates to resting, fasted rates observed in the eucaloric state in a dose dependent manner. The effect of EAA intakes above 15 g on resting and post-exercise muscle protein synthesis and the whole-body protein anabolic response during acute energy deficit has not been determined. This study will assess resting and post-resistance exercise whole-body and skeletal muscle protein synthesis responses to across a spectrum of EAA intakes following a well-controlled, short-term (5-d) energy deficit (30% energy deficit). Using a randomized, double-blind, cross-over design, 20 resistance trained (≥ 2 d/wk for the past 6 mo) adults will undergo two, non-consecutive 5-d energy deficit periods, separated by a 14-d washout period. Resting and post-resistance exercise (single leg exercise model) whole-body protein turnover and skeletal muscle protein synthesis responses to two different doses of EAA (standard, 0.10 g/kg vs high, 0.30 g/kg) will be determined the morning after completing the 5-d energy deficit. This design will test the hypothesis that higher absolute doses of EAA are required to maintain resting and post-exercise anabolic responses during energy deficit.

Conditions

Muscle Protein Synthesis; Whole-body Protein Balance

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

Standard EAA Dose

EAA dose provided at 0.10 g/kg body mass

Group Type: EXPERIMENTAL

Standard EAA

Intervention Type: DIETARY_SUPPLEMENT

EAA provided relative to body mass at a standard dose (0.10 g/kg) during energy deprivation

High EAA Dose

EAA dose provided at 0.30 g/kg body mass

Group Type: EXPERIMENTAL

High EAA

Intervention Type: DIETARY_SUPPLEMENT

EAA provided relative to body mass at a high dose (0.30 g/kg) during energy deprivation

Interventions

Standard EAA

EAA provided relative to body mass at a standard dose (0.10 g/kg) during energy deprivation

Intervention Type: DIETARY_SUPPLEMENT

High EAA

EAA provided relative to body mass at a high dose (0.30 g/kg) during energy deprivation

Intervention Type: DIETARY_SUPPLEMENT

Eligibility 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)
• 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 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
• Pregnancy (self-report or results of urine pregnancy test before body composition testing)
• Unwillingness or inability to consume study diets or foods provided

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Arkansas

OTHER

Sponsor Role: collaborator

Eastern Michigan University

OTHER

Sponsor Role: collaborator

United States Army Research Institute of Environmental Medicine

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Stefan M Pasiakos, PhD

Role: PRINCIPAL_INVESTIGATOR

Military Nutrition Division, USARIEM

Locations

US Army Research Institute of Environmental Medicine

Natick, Massachusetts, United States

Countries

United States

References

Gwin JA, Church DD, Hatch-McChesney A, Howard EE, Carrigan CT, Murphy NE, Wilson MA, Margolis LM, Carbone JW, Wolfe RR, Ferrando AA, Pasiakos SM. Effects of high versus standard essential amino acid intakes on whole-body protein turnover and mixed muscle protein synthesis during energy deficit: A randomized, crossover study. Clin Nutr. 2021 Mar;40(3):767-777. doi: 10.1016/j.clnu.2020.07.019. Epub 2020 Jul 22.

Reference Type: DERIVED

PMID: 32768315 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

17-32HC

Identifier Type: -

Identifier Source: org_study_id