Nighttime Synchrony of Your Nutrition and Circadian Health (N-Sync)

Utah System of Higher Education (USHE)

Status: Enrolling

Conditions: Light Exposure; Circadian Rhythm; Sleep Hygiene, Inadequate; Circadian Dysregulation; Lifestyle Factors; Insufficient Sleep; Circadian Misalignment; Sleep Deprivation; Metabolism Changes; Sleep; Sleep Hygiene

Treatments: Behavioral: Central Clock Misalignment; Behavioral: Peripheral Misalignment

Study type: Interventional

Funder types: Other

Identifiers

NCT07329283

185590

Details and patient eligibility

About

Sleep is an important factor for overall health. This study will see how different light exposure patterns and food intake impact a person's metabolism (how the body breaks down food) when sleeping is reduced.

Participants will attend 6 to 8 in-person visits to the study clinic, including three overnight stays. People will complete surveys and medical tests. The study will last about 4 to 6 months.

Full description

This study is a randomized in-lab, cross-over trial. Each participant will complete all three arms in either condition order #1 (A-B-C) or order #2 (A-C-B). Each arm will consist of 5 nights of experimental sleep restriction followed by a constant routine protocol for assessment of 24-h rhythms. Sleep restriction in the three arms will occur under the following conditions: (A-control condition) Sleep Restriction with Central and Peripheral Alignment; (B) Sleep Restriction with Central Clock Misalignment; and (C) Sleep Restriction with Peripheral Misalignment. Prior to enrollment participants will complete a comprehensive medical history and clinical overnight sleep disorders screening. Baseline consists of a ~2-week ambulatory real-world monitoring segment that will occur immediately prior to each in-lab sleep restriction condition. Following the 5 days of sleep restriction in each arm, participants will complete an intravenous glucose tolerance test to analyze insulin sensitivity, prior to completing the constant routine.

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 35 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Age: 18-35 years old; equal numbers of men and women
2. Body Mass Index (BMI): 18.5-24.9 kg/m2
3. Sleep Habits: habitual self-reported average total sleep time (TST) 7-9 hours per night for prior 6 months

Exclusion criteria

1. Clinically diagnosed sleep disorder or apnea hypopnea index (AHI) ≥5
2. Evidence of significant organ system dysfunction or disease (e.g., heart disease, diabetes)
3. Fasting plasma glucose ≥100 mg/dL
4. Major psychiatric illness (e.g., major depressive disorder)
5. Cancer that has been in remission less than 5 years
6. History of shift-work in prior year
7. Weight change >5% of body weight over prior six months
8. Currently following a weight-loss program
9. Menopause
10. Pregnant/nursing
11. Greater than 5-day variation in menstrual cycle length month-to-month
12. Currently smoking
13. Alcohol intake >14 drinks/week or >3 drinks/day.
14. Use of prescription medications (except oral contraceptives) within one month prior to or during in-lab visits.
15. Consumption of illegal drugs or >500mg per day of caffeine.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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120 participants in 3 patient groups

Sleep Restriction with Central and Peripheral Alignment

No Intervention group

Description:

(Arm "A")-Control condition with central and peripheral aligned circadian rhythms

Sleep Restriction with Central Clock Misalignment

Experimental group

Description:

(Arm "B")-Misalignment of the central clock by nighttime electrical light exposure and dim-light in morning hours.

Treatment:

Behavioral: Central Clock Misalignment

Sleep Restriction with Peripheral Misalignment

Experimental group

Description:

(Arm "C")-Misalignment of peripheral oscillators by shifting the majority of food intake to the nighttime hours.

Treatment:

Behavioral: Peripheral Misalignment