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Protein Nutrition for Sleep Deprivation (PSL Trial)
N/A
Waitlist Available
Led By Jess A Gwin, PhD
Research Sponsored by United States Army Research Institute of Environmental Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Adults aged 18 - 39 years
Biological females must have normal menstrual cycles between 26-32 days in duration; 5 menstrual cycles within the past 6 months; or able to provide self-report documentation of sustained oral/hormonal contraceptive use which contains low-dose estrogen/progesterone to maintain continuous hormonal levels
Must not have
Unwilling or unable to consume study diets or foods provided due to personal preference, dietary restrictions, and/or food allergies
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 72 hours
Awards & highlights
No Placebo-Only Group
Summary
This trial will study how protein affects muscle and blood protein levels in adults who experience sleep loss, and if distributing protein evenly during recovery helps.
Who is the study for?
This trial is for healthy adults aged 18-39 with a BMI under 30, who exercise regularly and have stable weight without chronic illness or sleep disorders. Women must have normal menstrual cycles or be on low-dose hormonal contraceptives. Participants can't smoke, drink alcohol, caffeine, use supplements during the study, and must not be pregnant or breastfeeding.
What is being tested?
The study tests if different protein nutrition distributions during recovery from military-like sleep loss help muscle protein synthesis (MPS) and whole body protein balance (WBPB). It involves a week of normal sleep, four days of restricted sleep (~4h/night), followed by three days' recovery with controlled protein intake.
What are the potential side effects?
There may not be direct side effects from the nutritional intervention itself; however, participants might experience discomfort related to blood draws, muscle biopsies and dietary changes. Sleep deprivation could cause fatigue or mood changes.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 18 and 39 years old.
Select...
I am a woman with regular menstrual cycles or have been on consistent low-dose hormonal birth control.
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I am willing to avoid alcohol, nicotine, caffeine, and supplements during the study.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I cannot follow the study's diet due to my dietary preferences, restrictions, or allergies.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 72 hours
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~72 hours
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Integrated Muscle Protein Synthesis
Whole-body Protein Balance
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Protein Nutrition EvenExperimental Treatment1 Intervention
Volunteers will consume 1.6 g protein/kg/d as an even (\~0.4/0.4/0.4/0.4 g/kg) distribution across breakfast, lunch, dinner, and a snack.
Group II: Protein Nutrition SkewedActive Control1 Intervention
Volunteers will consume 1.6 g protein/kg/d as a skewed (\~0.11/0.27/1.15/0.07 g/kg) distribution across breakfast, lunch, dinner, and a snack.
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Who is running the clinical trial?
United States Army Research Institute of Environmental MedicineLead Sponsor
64 Previous Clinical Trials
3,614 Total Patients Enrolled
Jess A Gwin, PhDPrincipal InvestigatorUnited States Army Research Institute of Environmental Medicine
1 Previous Clinical Trials
17 Total Patients Enrolled