SleepN-SyncNCT07329283
Nighttime Synchrony of Your Nutrition and Circadian Health
A study testing Central Clock Misalignment and Peripheral Misalignment in people with Sleep and Metabolism Changes, run by University of Utah at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep, Metabolism Changes, Circadian Rhythm
- What is being tested?
- Central Clock Misalignment and Peripheral Misalignment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Dec 2025to 31 May 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 15Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
College of Health Research Complex - University of Utah, Salt Lake City 84112
Salt Lake City, Utah, 84112
Christopher Depner, PhD, 8015812275, sleepstudyparticipant@utah.edu
Christopher Depner, PhD
About this study
Official title: 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.
Read the 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.
- Conditions
- Sleep, Metabolism Changes, Circadian Rhythm, Lifestyle Factors, Sleep Hygiene, Sleep Hygiene, Inadequate
- Being tested
- Central Clock Misalignment, Peripheral Misalignment
- Keywords
- Sleep, Light Exposure, Metabolism, Circadian Rhythm, Food Intake, Lifestyle Factors, Sleep Hygiene
- Medical subject headings
- Sleep Hygiene, Sleep Deprivation, Chronobiology Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Central Clock MisalignmentBehavioural
Light exposure will be dimmed during the first 4 hours of scheduled wakefulness, with bright light exposure during the nighttime hours of extended wakefulness.
Peripheral MisalignmentBehavioural
Most daily calories will be given later in the day to shift eating patterns toward the nighttime hours.
| Study group | Role | What they receive |
|---|---|---|
| Sleep Restriction with Central and Peripheral Alignment | No intervention | (Arm "A")-Control condition with central and peripheral aligned circadian rhythms |
| Sleep Restriction with Central Clock Misalignment | Experimental | (Arm "B")-Misalignment of the central clock by nighttime electrical light exposure and dim-light in morning hours. Receives: Behavioral: Central Clock Misalignment |
| Sleep Restriction with Peripheral Misalignment | Experimental | (Arm "C")-Misalignment of peripheral oscillators by shifting the majority of food intake to the nighttime hours. Receives: Behavioral: Peripheral Misalignment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insulin Sensitivity
Insulin sensitivity will be measured by intravenous glucose tolerance tests.
Measured: Immediately following the 5-day sleep restriction segment
Internal Circadian Misalignment (Uridine and Isobutyryl-L-carnitine)
Phase angle between DLMO and acrophase of uridine and isobutyryl-L-carnitine during constant routine.
Measured: During the constant routine, following the 5-day sleep restriction segment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2026
- Study start19 Dec 2025
- Primary completion31 May 2030 (estimated)
- Study completion31 May 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SleepStudies of the same condition, open and under way.
- More trials run by University of UtahThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christopher Depner, University of Utah
- Investigators
- Christopher Depner, PhD, Principal investigator, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07329283
- Sponsor's protocol ID
- 185590
- Acronym
- N-Sync
- Status last verified
- Jan 2026
- First submitted
- 11 Dec 2025
- Last updated
- 22 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nighttime Synchrony of Your Nutrition and Circadian Health: The N-Sync Study
- ClinicalTrials.gov ID
- NCT07329283
- Acronym / sponsor ID
- N-Sync / 185590
- Conditions
- Sleep, Metabolism Changes, Circadian Rhythm, Lifestyle Factors, Sleep Hygiene, Sleep Hygiene, Inadequate
- Keywords
- Sleep, Light Exposure, Metabolism, Circadian Rhythm, Food Intake, Lifestyle Factors, Sleep Hygiene
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Study start
- 19 Dec 2025 (actual)
- Primary completion
- 31 May 2030 (estimated)
- Study completion
- 31 May 2031 (estimated)
- First posted
- 9 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Sleep Restriction with Central and Peripheral Alignment | No intervention | –(Arm "A")-Control condition with central and peripheral aligned circadian rhythms |
| Sleep Restriction with Central Clock Misalignment | Experimental | Behavioral: Central Clock Misalignment(Arm "B")-Misalignment of the central clock by nighttime electrical light exposure and dim-light in morning hours. |
| Sleep Restriction with Peripheral Misalignment | Experimental | Behavioral: Peripheral Misalignment(Arm "C")-Misalignment of peripheral oscillators by shifting the majority of food intake to the nighttime hours. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Central Clock MisalignmentLight exposure will be dimmed during the first 4 hours of scheduled wakefulness, with bright light exposure during the nighttime hours of extended wakefulness. | Behavioural | Sleep Restriction with Central Clock Misalignment |
| Peripheral MisalignmentMost daily calories will be given later in the day to shift eating patterns toward the nighttime hours. | Behavioural | Sleep Restriction with Peripheral Misalignment |
Primary outcome
Insulin Sensitivity
Time frame: Immediately following the 5-day sleep restriction segment
Insulin sensitivity will be measured by intravenous glucose tolerance tests.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Christopher Depner, PhD principal investigator
University of Utah
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Central Clock Misalignment and Peripheral Misalignment in people with Sleep and Metabolism Changes, run by University of Utah at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Victoria Miranda, MS (385-309-0551, SleepStudyParticipant@utah.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Insulin Sensitivity (time frame: Immediately following the 5-day sleep restriction segment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2026.