Effect of Sleep Extension on Ceramides in People With Overweight and Obesity
Recruiting · NCT06180837 · Interventional (participants receive a specific treatment) · Lead sponsor: University of Utah
View the official record on ClinicalTrials.gov →Interventions studied
Sleep Extension Intervention
What this trial is about
The overall goal is to determine how a sleep extension intervention (increasing time in bed) in individuals who maintain less than 6.5 hours sleep per night affects their plasma ceramides and insulin sensitivity. Participants will undergo a randomized controlled trial, with sleep extension (intervention) and healthy lifestyle (control) groups. The sleep extension is designed to increase participant's time in bed by 2 hours per night. Alternatively, the control group will receive basic health information (e.g., physical activity, goal setting, and nutrition when eating out).
Who can take part
Age range
18 Years to 45 Years
Sex
All (male and female)
Healthy volunteers
Yes - healthy volunteers may be accepted
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- Age: 18-45 years old; equal numbers of men and women
- Body mass index (BMI): 27.5-34.9 kg/m2
- Sleep Habits: habitual self-reported average total sleep time (TST) \<6.5 hours per night for prior 6 months
Exclusion criteria
- Clinically diagnosed sleep disorder or major psychiatric illness
- Evidence of significant organ dysfunction or disease (e.g., heart disease, kidney disease)
- Clinically diagnosed diabetes or fasting plasma glucose ≥126 mg/dL or HbA1c ≥6.5%
- Use of prescription drugs or substances known to influence sleep or glucose metabolism, or anticoagulant medications.
- Cancer that has been in remission less than 5 years
- Pregnant/nursing, experiencing menopause or post-menopausal
- Shift-work: current or history of within last year
- Weight change: \>10% of body weight over prior six months
- Current enrollment in weight loss or physical activity program like the Diabetes Prevention Program
- Currently smoking
- Alcohol intake\>14 drinks per week or \>3 drinks per day
Where it is running
1 location listed across 1 US state.
- College of Health Research Complex--University of Utah - Salt Lake City, Utah, United States