Protein Nutrition for Sleep Deprivation

(PSL Trial)

Overseen By Jess A Gwin, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: United States Army Research Institute of Environmental Medicine

Disqualifiers: Metabolic, Cardiovascular, Gastrointestinal, Substance abuse, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

20 Participants Needed

Trial Summary

What is the purpose of this trial?

The current study will determine protein nutritional status (MPS and WBPB) in response to military-relevant sleep loss, and whether an even protein nutrition distribution during recovery optimally supports MPS and WBPB. Adults (n=20) will complete a 7d sleep satiated phase (\~7-9h target/d), a 4d military-relevant sleep restriction phase (\~4h /d), and a 3d recovery phase (\~7-9h target/d) in a randomized, parallel design. During recovery, volunteers will consume 1.6 g protein/kg/d as an even (\~0.4/0.4/0.4/0.4 g/kg) or skewed (\~0.11/0.27/1.15/0.07 g/kg) distribution. Sleep will be monitored throughout the study using wrist actigraphy and diaries. During each phase, integrated daily MPS will be estimated using ingested deuterium oxide, salivary and blood sampling, and muscle biopsies, while WBPB will be estimated using ingested 15-N alanine and urine collections. At the end of each phase, metabolic testing will be used to assess the effects of sleep loss on substrate utilization and include consuming a carbohydrate beverage, serial blood draws, indirect calorimetry, and steady-state aerobic exercise. The knowledge products derived from the proposed effort will be informative to next generation ration development and support military-specific recovery nutrition guidance following operations involving sleep loss.

Research Team

Jess A Gwin, PhD

Principal Investigator

United States Army Research Institute of Environmental Medicine

Eligibility Criteria

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.

Inclusion Criteria

You have been regularly doing aerobic or strength exercises at least 2 days a week for the past 6 months.

Your weight has stayed about the same for the past 2 months, give or take 3 kilograms.

I am healthy with no chronic illness, injury, or sleep disorder.

Exclusion Criteria

You have had problems with lidocaine or a similar numbing medication in the past.

You are currently using drugs or alcohol, as reported by you or confirmed by a doctor.

Unwilling or unable to adhere to study physical restrictions or sleep prescriptions

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Sleep Satiated Phase

Participants undergo a 7-day phase with 7-9 hours of sleep per day to establish baseline conditions

7 days

Daily monitoring

Sleep Restriction Phase

Participants experience a 4-day phase with military-relevant sleep restriction of approximately 4 hours per day

4 days

Daily monitoring

Recovery Phase

Participants undergo a 3-day recovery phase with 7-9 hours of sleep per day, consuming 1.6 g protein/kg/day in either an even or skewed distribution

3 days

Daily monitoring

Follow-up

Participants are monitored for safety and effectiveness after the intervention phases

4 weeks

Treatment Details

Interventions

• Protein Nutrition During Recovery

Trial Overview 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.

Participant Groups

Group I: Protein Nutrition Even Experimental Treatment 1 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 Skewed Active Control 1 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.

Who Is Running the Clinical Trial?

United States Army Research Institute of Environmental Medicine

Lead Sponsor

Trials

67

Recruited

3,700+