Improving cardiometabolic health through circadian interventions
Timing of Circadian Synchronizers: the TOCS Study
This study is testing whether changing sleep habits and reducing nighttime light and eating can help people with overweight and obesity who don’t get enough sleep improve their health over eight weeks.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years to 45 Years |
| Sex | All |
| Sponsor | University of Utah Academic / other |
| Locations | 1 site (Salt Lake City, Utah) |
| Trial ID | NCT05943626 on ClinicalTrials.gov |
What this trial studies
This study examines the effectiveness of a circadian intervention aimed at improving cardiometabolic health in individuals with overweight and obesity who experience habitual short sleep duration. Participants will be randomly assigned to either a circadian intervention group, which focuses on reducing nighttime light exposure and late-night eating, or a control group that receives basic health information. The study will monitor sleep duration and assess insulin sensitivity through various tests over an 8-week period. The goal is to determine if adjusting circadian rhythms can lead to better health outcomes.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-45 with a BMI between 25.0-34.9 and who report sleeping less than 6.5 hours per night.
Not a fit: Patients with clinically diagnosed sleep disorders, significant organ dysfunction, or those currently pregnant may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could lead to improved cardiometabolic health and better management of conditions like Type 2 diabetes.
How similar studies have performed: While the specific approach of this study may be novel, similar interventions focusing on circadian rhythms have shown promise in improving health outcomes in other studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Age: 18-45 years old; equal numbers of men and women 2. Body mass index (BMI): 25.0-34.9 kg/m2, 3. Sleep Habits: habitual self-reported average total sleep time (TST) \<6.5 hours per night for prior 6 months Exclusion Criteria: 1. Clinically diagnosed sleep disorder or major psychiatric illness 2. Evidence of significant organ dysfunction or disease (e.g., diagnosed diabetes, cardiovascular disease, or kidney disease) 3. Use of prescription drugs or substances known to influence sleep or glucose metabolism 4. Shift-work: current or history of within last year 5. Weight change: \>10% of body weight over prior six months 6. Experiencing menopause or post-menopausal 7. Current enrollment in weight loss or physical activity program like the Diabetes Prevention Program 8. Currently pregnant or planning to become pregnant, or currently lactating. 9. Currently smoking 10. Alcohol intake \>3 drinks per day or \>14 drinks per week
Where this trial is running
Salt Lake City, Utah
- College of Health Research Complex--University of Utah — Salt Lake City, Utah, United States (Recruiting)
Study contacts
- Study coordinator: Christopher M Depner, PhD
- Email: christopher.depner@utah.edu
- Phone: 801-581-2275
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.