Status:
COMPLETED
Effects of Varying Energy Deficits on Protein Turnover At Rest and Carbohydrate Oxidation During Steady-state Exercise
Lead Sponsor:
United States Army Research Institute of Environmental Medicine
Conditions:
Energy Supply; Deficiency, Severe
Energy Supply; Deficiency
Eligibility:
All Genders
18-35 years
Phase:
NA
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) carbohy...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 16 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 7 2024
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04910724
Start Date
August 16 2022
End Date
March 7 2024
Last Update
January 27 2025
Active Locations (1)
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1
US Army Research Institute of Environmental Medicine
Natick, Massachusetts, United States, 01760