Nighttime Synchrony of Your Nutrition and Circadian Health
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Central Clock Misalignment, Peripheral Misalignment.
- Who it may be relevant to
- Registry conditions: Sleep, Metabolism Changes, Circadian Rhythm, Lifestyle Factors. Basic parameters: 18 years — 35 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Nighttime Synchrony of Your Nutrition and Circadian Health: The N-Sync Study
Overview
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.
Detailed 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.
Interventions
- Behavioral Central Clock Misalignment
Light exposure will be dimmed during the first 4 hours of scheduled wakefulness, with bright light exposure during the nighttime hours of extended wakefulness. - Behavioral Peripheral Misalignment
Most daily calories will be given later in the day to shift eating patterns toward the nighttime hours.
Primary outcome measures
- Insulin Sensitivity [Time frame: Immediately following the 5-day sleep restriction segment]
- Internal Circadian Misalignment (Uridine and Isobutyryl-L-carnitine) [Time frame: During the constant routine, following the 5-day sleep restriction segment]
Eligibility criteria
Inclusion criteria
- Age: 18-35 years old; equal numbers of men and women
- Body Mass Index (BMI): 18.5-24.9 kg/m2
- Sleep Habits: habitual self-reported average total sleep time (TST) 7-9 hours per night for prior 6 months
Exclusion criteria
- Clinically diagnosed sleep disorder or apnea hypopnea index (AHI) ≥5
- Evidence of significant organ system dysfunction or disease (e.g., heart disease, diabetes)
- Fasting plasma glucose ≥100 mg/dL
- Major psychiatric illness (e.g., major depressive disorder)
- Cancer that has been in remission less than 5 years
- History of shift-work in prior year
- Weight change >5% of body weight over prior six months
- Currently following a weight-loss program
- Menopause
- Pregnant/nursing
- Greater than 5-day variation in menstrual cycle length month-to-month
- Currently smoking
- Alcohol intake >14 drinks/week or >3 drinks/day.
- Use of prescription medications (except oral contraceptives) within one month prior to or during in-lab visits.
- Consumption of illegal drugs or >500mg per day of caffeine.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Triple blind
- Primary purpose
- Basic science
Study locations
United States · 1 center
- College of Health Research Complex - University of Utah, Salt Lake City 84112 — Salt Lake City
Identifiers
NCT: NCT07329283 · 185590