Energy Deficit Clinical Trial
Official title:
Determining Optimal Energy Substrate to Enhance Postprandial Protein Kinetic Responses to Essential Amino Acid-enriched Whey During Energy Deficit
| Verified date | October 2022 |
| Source | United States Army Research Institute of Environmental Medicine |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
Previous work conducted by the Investigators demonstrates that an essential amino acid(EAA)-enriched whey protein combination format is an efficient EAA/protein format to support enhanced whole-body protein balance and sustain muscle protein synthesis compared to isonitrogenous amounts of whey alone or a mixed-macronutrient meal. However, additional work is needed to optimize the formulation to ensure the best possible muscle and whole-body anabolic responses are achieved. This includes addressing the potential value of adding non-EAA/protein components to support energy demands. Providing additional non-protein energy to an EAA-enriched whey protein formulation may reduce the proportion of exogenous amino acids directed towards energy production thereby preserving its use for muscle protein synthesis. However, whether suppressing exogenous amino acid oxidation by providing additional carbohydrate allows for a greater muscle protein synthetic stimulus during moderate energy deficit (- 30% total energy requirements) is unknown. Therefore, this study will test the effects of EAA-enriched whey protein plus carbohydrate versus EAA-enriched whey plus additional EAA using a randomized, cross-sectional longitudinal study design.
| Status | Active, not recruiting |
| Enrollment | 17 |
| Est. completion date | January 2023 |
| Est. primary completion date | January 2023 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 18 Years to 35 Years |
| Eligibility | Inclusion Criteria: - Body mass index < 30.0 kg/m2 - Weight stable in the past 2 months (± 2.27 kg) - 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 - Functional exercise (i.e., step ups, box jumps, body mass movements) and/or aerobic exercise trained defined by self-report as performing = 2 sessions/wk 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 ~8.5 hour laboratory day and at least 5 days after completing the last ~8.5 hour laboratory day - Willing to refrain from alcohol, smoking any nicotine product (includes e-cigarettes), vaping, chewing tobacco, caffeine, and dietary supplements after the completing the baseline period until the end of the study - Must obtain supervisor approval for federal civilian employees and non-HRV active duty military personnel working within the US Army Natick Soldier Systems Center - 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.) - 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 as assessed by OMSO - Participation in 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 due to personal preference, dietary restrictions, and/or food allergies - Unwillingness to adhere to study physical restrictions |
| Country | Name | City | State |
|---|---|---|---|
| United States | US Army Research Institute of Environmental Medicine | Natick | Massachusetts |
| Lead Sponsor | Collaborator |
|---|---|
| United States Army Research Institute of Environmental Medicine | Eastern Michigan University, University of Arkansas |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Whole-body Protein Balance | Whole-body net balance will be determined using stable-isotope methodologies | approximately 5.75 hours | |
| Primary | Whole-body Protein Synthesis | Whole-body protein synthesis will be determined using stable-isotope methodologies | approximately 5.75 hours | |
| Primary | Whole-body Protein Breakdown | Whole-body protein breakdown will be determined using stable-isotope methodologies | approximately 5.75 hours | |
| Primary | Muscle Protein Synthesis | Muscle protein synthesis will be determined using stable-isotope methodologies | approximately 5.75 hours |