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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)
Sponsor: Beijing Anzhen Hospital
Summary
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.
Key Details
Gender
All
Age Range
18 Years - 50 Years
Study Type
INTERVENTIONAL
Enrollment
40
Start Date
2026-12
Completion Date
2028-12
Last Updated
2026-10-27
Healthy Volunteers
Yes
Conditions
Interventions
n-3 PUFA Supplementation
Participants will receive two oral fish oil softgel capsules daily, providing approximately 1.1 g/day of EPA and DHA, for approximately 75 days, including the residential sleep restriction period.
Placebo Supplementation
Participants will receive two matching placebo softgel capsules containing vegetable oil without EPA or DHA daily for approximately 75 days, including the residential sleep restriction period.
Experimental Sleep Restriction
All participants will undergo a standardized 19-day residential sleep protocol, including 3 days of adaptation, 14 days of sleep restriction (00:30-04:30), and 2 days of recovery.