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Effects of Varying Energy Deficits on Protein Turnover at Rest and Carbohydrate Oxidation During Steady-state Exercise

Primary Purpose

Energy Supply; Deficiency, Severe, Energy Supply; Deficiency, Stress, Physiological

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Energy Deficit
Sponsored by
United States Army Research Institute of Environmental Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Energy Supply; Deficiency, Severe

Eligibility Criteria

18 Years - 35 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Men and women aged 18 - 35 years
  • Body mass index < 30.0 kg/m2
  • Weight stable for the past 2 months (± ~2.27 kg)
  • Healthy without evidence of chronic illness or musculoskeletal injury as determined by the US Army Research Institute of Environmental Medicine Office of Medical Support and Oversight (OMSO) or home duty station medical support
  • Routinely participate in aerobic and/or resistance exercise at least 2 days per week defined by self-report for previous 6 months
  • Willing to refrain from taking any nonsteroidal anti-inflammatory drugs (e.g., aspirin, Advil®, Aleve®, Naprosyn®), or any other aspirin-containing product for 10 days before the first muscle biopsy and at least 5 days after completing the last muscle biopsy
  • Willing to refrain from alcohol, smoking/using any nicotine product (includes e-cigarettes, vaping, chewing tobacco), caffeine, and dietary supplements during the intervention periods of the study
  • Supervisor approval for federal civilian employees and non-Natick Soldier Systems Center Human Research Volunteer (HRV) active duty military personnel
  • Females must have normal menstrual cycles between 26-32 days in duration; 5 menstrual cycles within the past 6 months; or able to provide documentation of oral/hormonal contraceptive use which contains low-dose estrogen/progesterone to maintain continuous levels throughout the 28-day cycle (i.e., no placebos)

Exclusion Criteria:

  • Metabolic or cardiovascular abnormalities, gastrointestinal disorders (e.g., kidney disease, diabetes, cardiovascular disease, etc.)
  • Significantly abnormal blood clotting as determined by OMSO or home duty station medical support
  • History of complications with lidocaine
  • Present condition of alcoholism, anabolic steroid use, or other substance abuse issues as determined by OMSO or home duty station medical support
  • Blood donation within 8-wk of beginning the study
  • Pregnant, trying to become pregnant, and/or breastfeeding (results of urine pregnancy test and self-report for breastfeeding will be obtained before body composition testing)
  • Unwilling or unable to consume study diets or foods provided due to personal preference, dietary restrictions, and/or food allergies
  • Unwilling or unable to adhere to study physical restrictions

Sites / Locations

  • US Army Research Institute of Environmental MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

20% Energy Deficit

40% Energy Deficit

60% Energy Deficit

Arm Description

Energy Deficit equal to 20% total daily energy requirements.

Energy Deficit equal to 40% total daily energy requirements.

Energy Deficit equal to 60% total daily energy requirements.

Outcomes

Primary Outcome Measures

Whole-body protein balance
Determined using L-[1-13C]-leucine stable isotope.
Muscle Protein Synthesis
Determined using L-[ring-2H5]-phenylalanine stable isotope.
Carbohydrate Oxidation during Steady-state Exercise
Determined using U-13C-glucose stable isotope.

Secondary Outcome Measures

Full Information

First Posted
May 27, 2021
Last Updated
October 24, 2022
Sponsor
United States Army Research Institute of Environmental Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT04910724
Brief Title
Effects of Varying Energy Deficits on Protein Turnover at Rest and Carbohydrate Oxidation During Steady-state Exercise
Official Title
Effects of Varying Energy Deficits on Protein Turnover at Rest and Carbohydrate Oxidation During Steady-state Exercise
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 2022 (Anticipated)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
United States Army Research Institute of Environmental Medicine

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This randomized, parallel study will examine the effects of energy balance and varying magnitudes of energy deficit on 1) the protein kinetic responses to consuming high quality protein and 2) carbohydrate oxidation during steady-state exercise. Healthy adults, representative of active duty military personnel, will complete a 2 d energy balance phase followed by a randomly assigned, 5 d energy deficit phase (n=15 per group; 20%, 40% and 60% energy deficit). At the end of each energy phase the effects of energy balance and energy deficit severity on resting postabsorptive (fasting) and postprandial (after consuming ~34 g protein) muscle protein synthesis (MPS) and whole-body protein synthesis, breakdown, and balance (synthesis - breakdown) will be determined. On the next day, the effects energy balance and energy deficit severity on carbohydrate oxidation during steady-state exercise will be determined. Primary study procedures include anthropometric and body composition measures, resting metabolic rate measures, aerobic exercise, tightly controlled diet and exercise interventions, repeated blood sampling, stable isotope infusion, stable isotope ingestion, and percutaneous muscle biopsies. The following hypotheses will be tested: 1) Δ (postprandial - postabsorptive) MPS and Δ whole-body protein balance at rest will progressively decrease as magnitude of energy deficit increases and 2) exogenous carbohydrate oxidation will be higher and endogenous carbohydrate oxidation will be lower during steady-state exercise as magnitude of energy deficit increases.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Energy Supply; Deficiency, Severe, Energy Supply; Deficiency, Stress, Physiological

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized, parallel study comparing the effects of 3 magnitudes of energy deficit.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
45 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
20% Energy Deficit
Arm Type
Experimental
Arm Description
Energy Deficit equal to 20% total daily energy requirements.
Arm Title
40% Energy Deficit
Arm Type
Experimental
Arm Description
Energy Deficit equal to 40% total daily energy requirements.
Arm Title
60% Energy Deficit
Arm Type
Experimental
Arm Description
Energy Deficit equal to 60% total daily energy requirements.
Intervention Type
Other
Intervention Name(s)
Energy Deficit
Intervention Description
A combination of individualized exercise performed on a cycle ergometer and individualized dietary prescriptions will be used to achieve energy balance or the assigned energy deficits throughout the controlled feeding and testing periods
Primary Outcome Measure Information:
Title
Whole-body protein balance
Description
Determined using L-[1-13C]-leucine stable isotope.
Time Frame
2 days
Title
Muscle Protein Synthesis
Description
Determined using L-[ring-2H5]-phenylalanine stable isotope.
Time Frame
2 days
Title
Carbohydrate Oxidation during Steady-state Exercise
Description
Determined using U-13C-glucose stable isotope.
Time Frame
2 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Men and women aged 18 - 35 years Body mass index < 30.0 kg/m2 Weight stable for the past 2 months (± ~2.27 kg) Healthy without evidence of chronic illness or musculoskeletal injury as determined by the US Army Research Institute of Environmental Medicine Office of Medical Support and Oversight (OMSO) or home duty station medical support Routinely participate in aerobic and/or resistance exercise at least 2 days per week defined by self-report for previous 6 months Willing to refrain from taking any nonsteroidal anti-inflammatory drugs (e.g., aspirin, Advil®, Aleve®, Naprosyn®), or any other aspirin-containing product for 10 days before the first muscle biopsy and at least 5 days after completing the last muscle biopsy Willing to refrain from alcohol, smoking/using any nicotine product (includes e-cigarettes, vaping, chewing tobacco), caffeine, and dietary supplements during the intervention periods of the study Supervisor approval for federal civilian employees and non-Natick Soldier Systems Center Human Research Volunteer (HRV) active duty military personnel Females must have normal menstrual cycles between 26-32 days in duration; 5 menstrual cycles within the past 6 months; or able to provide documentation of oral/hormonal contraceptive use which contains low-dose estrogen/progesterone to maintain continuous levels throughout the 28-day cycle (i.e., no placebos) Exclusion Criteria: Metabolic or cardiovascular abnormalities, gastrointestinal disorders (e.g., kidney disease, diabetes, cardiovascular disease, etc.) Significantly abnormal blood clotting as determined by OMSO or home duty station medical support History of complications with lidocaine Present condition of alcoholism, anabolic steroid use, or other substance abuse issues as determined by OMSO or home duty station medical support Blood donation within 8-wk of beginning the study Pregnant, trying to become pregnant, and/or breastfeeding (results of urine pregnancy test and self-report for breastfeeding will be obtained before body composition testing) Unwilling or unable to consume study diets or foods provided due to personal preference, dietary restrictions, and/or food allergies Unwilling or unable to adhere to study physical restrictions
Facility Information:
Facility Name
US Army Research Institute of Environmental Medicine
City
Natick
State/Province
Massachusetts
ZIP/Postal Code
01760
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jess Gwin, PhD
Phone
508-206-2300
Email
jessica.a.gwin.ctr@mail.mil

12. IPD Sharing Statement

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Effects of Varying Energy Deficits on Protein Turnover at Rest and Carbohydrate Oxidation During Steady-state Exercise

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