NCT07897097Not yet recruiting
Study on the Mechanism of Central Obesity Induced by Sleep Restriction and the Therapeutic Effect of n-3 Polyunsaturated Fatty Acid: a Randomized, Double-blind, Placebo-controlled Trial (COSPA Study)
Source: ClinicalTrials.gov · Last updated 27 Oct 2026
Brief summary (registry, in English)
This randomized, double-blind, placebo-controlled trial aims to investigate whether n-3 polyunsaturated fatty acid (PUFA) supplementation attenuates abdominal visceral fat accumulation induced by experimental sleep restriction. Forty healthy adults aged 18-50 years will be randomly assigned to receive n-3 PUFA supplementation (approximately 1.1 g/day of EPA and DHA) or a matching placebo. The intervention will last approximately 75 days, including a 19-day residential sleep protocol consisting of 3 adaptation days, 14 days of sleep restriction (4 hours per night), and 2 recovery days. The primary outcome is the change in abdominal visceral adipose tissue area measured by CT. Additional assessments include body composition, metabolic and inflammatory markers, gut microbiota, microbial metabolites, and adipose tissue molecular profiles.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 40 (estimated)
- First submitted
- 16 Oct 2026
- Start date
- Dec 2026
- Primary completion date
- Oct 2028
- Lead sponsor
- Beijing Anzhen Hospital
- Diseases
- Obesity
- NCT number
- NCT07897097
What you commit to
- Study type: Interventional
- Planned participants: 40
- From Dec 2026 to the primary completion date, Oct 2028
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Diagnosed with obstructive sleep apnea (OSA) or other sleep disorders based on sleep monitoring.
- History of or current chronic diseases that may affect metabolism or study safety, including hypertension, diabetes mellitus, coronary heart disease, or kidney disease.
- Allergy to fish oil or related components, or current use or use within the past 3 months of dietary supplements containing n-3 polyunsaturated fatty acids (n-3 PUFAs).
Other
- Obesity (BMI ≥28 kg/m²).
- Current smoking.
- Pregnancy or breastfeeding, menopause, or current use of oral contraceptives.
- Presence of an intrauterine device (IUD), which may interfere with CT-based assessment of abdominal fat.
Who the study is looking for
- Age ≥18 and ≤50 years.
- Currently not taking any medications.
- Regular sleep-wake schedule during the past month, with a usual sleep duration of 6-8 hours per night.
- Willing to reside in the sleep center for 19 days, comply with the prescribed sleep-wake schedule, and provide written informed consent.
Age in the registry: 18 years to 50 years · Sex: All · Accepts healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.