- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04910724
Effects of Varying Energy Deficits on Protein Turnover at Rest and Carbohydrate Oxidation During Steady-state Exercise
October 24, 2022 updated by: United States Army Research Institute of Environmental Medicine
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.
Study Overview
Status
Recruiting
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
45
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Massachusetts
-
Natick, Massachusetts, United States, 01760
- Recruiting
- US Army Research Institute of Environmental Medicine
-
Contact:
- Jess Gwin, PhD
- Phone Number: 508-206-2300
- Email: jessica.a.gwin.ctr@mail.mil
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 35 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 20% Energy Deficit
Energy Deficit equal to 20% total daily energy requirements.
|
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
|
Experimental: 40% Energy Deficit
Energy Deficit equal to 40% total daily energy requirements.
|
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
|
Experimental: 60% Energy Deficit
Energy Deficit equal to 60% total daily energy requirements.
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Whole-body protein balance
Time Frame: 2 days
|
Determined using L-[1-13C]-leucine stable isotope.
|
2 days
|
Muscle Protein Synthesis
Time Frame: 2 days
|
Determined using L-[ring-2H5]-phenylalanine stable isotope.
|
2 days
|
Carbohydrate Oxidation during Steady-state Exercise
Time Frame: 2 days
|
Determined using U-13C-glucose stable isotope.
|
2 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
November 1, 2022
Primary Completion (Anticipated)
December 1, 2023
Study Completion (Anticipated)
December 1, 2023
Study Registration Dates
First Submitted
May 27, 2021
First Submitted That Met QC Criteria
May 27, 2021
First Posted (Actual)
June 2, 2021
Study Record Updates
Last Update Posted (Actual)
October 25, 2022
Last Update Submitted That Met QC Criteria
October 24, 2022
Last Verified
October 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 21-09HC
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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