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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 72 hours
Awards & highlights

PSL Trial 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.Check my eligibility
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.See study design
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.

PSL Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 39 years old.
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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.

PSL Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~72 hours
This trial's timeline: 3 weeks for screening, Varies for treatment, and 72 hours for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Integrated Muscle Protein Synthesis
Whole-body Protein Balance

PSL 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
60 Previous Clinical Trials
3,418 Total Patients Enrolled
Jess A Gwin, PhDPrincipal InvestigatorUnited States Army Research Institute of Environmental Medicine
1 Previous Clinical Trials
17 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this experiment enlisting elderly individuals?

"According to the requirements of this trial, patients should be aged 18-39 in order to participate."

Answered by AI

Are there particular qualifications that render someone suitable for this research?

"In order to apply for this trial, prospective patients must suffer from insomnia and be between 18-39 years of age. There are only 20 open spots available in total."

Answered by AI

Is enrollment to this experiment currently a possibility?

"According to the clinicaltrials.gov database, this study has ended its recruitment efforts but there are still 44 other medical studies that have openings for participants. This trial was initially posted on January 1st 2024 and had its last update recorded as October 4th 2023."

Answered by AI
~13 spots leftby Jul 2025