Effect of Sleep Extension on Ceramides in People with Overweight and Obesity (NCT06180837) | Clinical Trial Compass
RecruitingNot Applicable
Effect of Sleep Extension on Ceramides in People with Overweight and Obesity
United States70 participantsStarted 2024-02-12
Plain-language summary
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 participate
Age range18 Years – 45 Years
SexALL
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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