- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07329283
Nighttime Synchrony of Your Nutrition and Circadian Health (N-Sync)
Nighttime Synchrony of Your Nutrition and Circadian Health: The N-Sync Study
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Victoria Miranda, MS
- Phone Number: 385-309-0551
- Email: SleepStudyParticipant@utah.edu
Study Contact Backup
- Name: Grace Zimmerman, PhD
- Phone Number: 385-309-0551
- Email: SleepStudyParticipant@utah.edu
Study Locations
-
-
Utah
-
Salt Lake City, Utah, United States, 84112
- Recruiting
- College of Health Research Complex - University of Utah, Salt Lake City 84112
-
Contact:
- Christopher Depner, PhD
- Phone Number: 8015812275
- Email: sleepstudyparticipant@utah.edu
-
Principal Investigator:
- Christopher Depner, PhD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Sleep Restriction with Central and Peripheral Alignment
(Arm "A")-Control condition with central and peripheral aligned circadian rhythms
|
|
|
Experimental: Sleep Restriction with Central Clock Misalignment
(Arm "B")-Misalignment of the central clock by nighttime electrical light exposure and dim-light in morning hours.
|
Light exposure will be dimmed during the first 4 hours of scheduled wakefulness, with bright light exposure during the nighttime hours of extended wakefulness.
|
|
Experimental: Sleep Restriction with Peripheral Misalignment
(Arm "C")-Misalignment of peripheral oscillators by shifting the majority of food intake to the nighttime hours.
|
Most daily calories will be given later in the day to shift eating patterns toward the nighttime hours.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Insulin Sensitivity
Time Frame: Immediately following the 5-day sleep restriction segment
|
Insulin sensitivity will be measured by intravenous glucose tolerance tests.
|
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
|
Phase angle between DLMO and acrophase of uridine and isobutyryl-L-carnitine during constant routine.
|
During the constant routine, following the 5-day sleep restriction segment
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Timing of DLMO and DLMOff
Time Frame: During the constant routine, following the 5-day sleep restriction segment
|
The phase angle between dim-light melatonin offset (DLMOff) scheduled waketime using hourly saliva samples collected during a constant routine.
|
During the constant routine, following the 5-day sleep restriction segment
|
|
Hunger and Satiety Visual Analog Scales
Time Frame: During the constant routine, following the 5-day sleep restriction segment
|
Self-reported ratings of hunger, satiety, and prospective food intake will be quantified by 100mm visual analog scales ranging from 0 to 100.
For each scale, 0 represents low hunger, satiety, or prospective food intake, with 100 representing the highest hunger, satiety, or prospective food intake.
|
During the constant routine, following the 5-day sleep restriction segment
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Christopher Depner, PhD, University of Utah
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 185590
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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