An interventional study of n-3 PUFA Supplementation and Placebo Supplementation in Sleep Deprivation, sponsored by Beijing Anzhen Hospital. Not yet recruiting. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-27.
Sponsored by Beijing Anzhen Hospital · Not applicable, Interventional, and Prevention
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.
Experimental sleep restriction provides a controlled model for investigating the metabolic consequences of insufficient sleep. This study will examine whether n-3 PUFA supplementation modifies visceral fat accumulation and related biological responses during sleep restriction.
Participants will undergo a standardized residential sleep protocol with continuous polysomnographic monitoring. Abdominal CT will be performed on Days 3 and 17 to assess changes in visceral and subcutaneous adipose tissue. Additional measurements will include dual-energy X-ray absorptiometry, ambulatory blood pressure monitoring, cognitive assessments, biological sample collection, and exploratory molecular analyses.
The study will also explore potential mechanisms involving gut microbiota, microbial metabolism, inflammation, and adipose tissue responses.
308 studies on the registry are indexed under Sleep Deprivation; 62 are open to participants now.
This study's planned enrollment of 40 is close to the median of 44 across 253 interventional studies indexed under Sleep Deprivation.
Browse Sleep Deprivation studies →Beijing Anzhen Hospital is the lead sponsor of 192 studies on the registry; 103 are open to participants now.
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Exclusion Criteria:
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.
Dietary Supplement: n-3 PUFA Supplementation · Behavioral: Experimental Sleep Restriction
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.
Dietary Supplement: Placebo Supplementation · Behavioral: Experimental Sleep Restriction
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.
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.
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.
Change in Visceral Adipose Tissue Area
Change in abdominal visceral adipose tissue area measured by CT, calculated as the value on Day 17 minus the value on Day 3, expressed in cm².
Time frame: Day 3 (T1) and Day 17 (T2)
Change in Subcutaneous Adipose Tissue Area
Change in abdominal subcutaneous adipose tissue (SAT) area measured by CT, calculated as SAT area on Day 17 minus SAT area on Day 3 (ΔSAT), expressed in cm²
Time frame: Day 3 (T1) and Day 17 (T2)
Change in Total Abdominal Adipose Tissue Area
Change in total abdominal adipose tissue (TAT) area measured by CT, calculated as TAT area on Day 17 minus TAT area on Day 3 (ΔTAT), expressed in cm²
Time frame: Day 3 (T1) and Day 17 (T2)
Change in Visceral-to-Subcutaneous Adipose Tissue Ratio
Change in the ratio of visceral to subcutaneous adipose tissue area (VAT/SAT), calculated as the ratio on Day 17 minus the ratio on Day 3
Time frame: Day 3 (T1) and Day 17 (T2)
Changes in Gut Microbial Alpha Diversity (Shannon Index)
Changes in fecal gut microbial alpha diversity measured by the Shannon diversity index using 16S rRNA gene sequencing. Shannon index values reflect microbial richness and evenness and are unitless.
Time frame: 8 weeks before the residential phase (T0), Day 3 (T1), Day 10, and Day 17 (T2)
Changes in Gut Microbial Beta Diversity (Bray-Curtis Dissimilarity)
Changes in gut microbial community composition assessed using Bray-Curtis dissimilarity based on 16S rRNA gene sequencing data. Between-sample differences will be evaluated using PERMANOVA.
Time frame: 8 weeks before the residential phase (T0), Day 3 (T1), Day 10, and Day 17 (T2)
Changes in Gut Microbial Taxonomic Abundance
Changes in the relative abundance of gut microbial taxa assessed by fecal microbiome sequencing and differential abundance analysis
Time frame: 8 weeks before the residential phase (T0), Day 3 (T1), Day 10, and Day 17 (T2)
Changes in Fecal Short-Chain Fatty Acid Concentrations
Changes in fecal short-chain fatty acid concentrations, including acetate, propionate, and butyrate, assessed using metabolomic methods.
Time frame: 8 weeks before the residential phase (T0), Day 3 (T1), Day 10, and Day 17 (T2)
Changes in High-Sensitivity C-Reactive Protein Levels
Changes in serum or plasma hs-CRP concentrations measured across the study time points.
Time frame: 8 weeks before the residential phase (T0), Day 3 (T1), Day 10, and Day 17 (T2)
Changes in Interleukin-6 Levels
Changes in serum or plasma IL-6 concentrations measured across the study time points.
Time frame: 8 weeks before the residential phase (T0), Day 3 (T1), Day 10, and Day 17 (T2)
Changes in Interleukin-10 Levels
Changes in serum or plasma IL-10 concentrations measured across the study time points.
Time frame: 8 weeks before the residential phase (T0), Day 3 (T1), Day 10, and Day 17 (T2)
Changes in Interleukin-18 Levels
Changes in serum or plasma IL-18 concentrations measured across the study time points.
Time frame: 8 weeks before the residential phase (T0), Day 3 (T1), Day 10, and Day 17 (T2)
Changes in Tumor Necrosis Factor-alpha Levels
Changes in serum or plasma TNF-α concentrations measured across the study time points.
Time frame: 8 weeks before the residential phase (T0), Day 3 (T1), Day 10, and Day 17 (T2)
Changes in Interleukin-1 Beta Levels
Changes in serum or plasma IL-1β concentrations measured across the study time points.
Time frame: 8 weeks before the residential phase (T0), Day 3 (T1), Day 10, and Day 17 (T2)
Changes in Monocyte Chemoattractant Protein-1 Levels
Changes in serum or plasma MCP-1/CCL2 concentrations measured across the study time points.
Time frame: 8 weeks before the residential phase (T0), Day 3 (T1), Day 10, and Day 17 (T2)
Changes in Adipose Tissue UCP1 mRNA Expression
Changes in relative UCP1 mRNA expression in adipose tissue biopsies measured by RT-qPCR between Day 3 and Day 17.
Time frame: Day 3 (T1) and Day 17 (T2)
Changes in Adipose Tissue UCP1 Protein Expression
Changes in relative UCP1 protein expression in adipose tissue biopsies measured by Western blot between Day 3 and Day 17.
Time frame: Day 3 (T1) and Day 17 (T2)
Changes in Total Body Fat Mass
Changes in total body fat mass measured by dual-energy X-ray absorptiometry (DEXA), expressed in kg.
Time frame: 8 weeks before the residential phase (T0), Day 3 (T1), Day 10, and Day 17 (T2)
Changes in Lean Body Mass
Changes in lean body mass measured by DEXA, expressed in kg.
Time frame: 8 weeks before the residential phase (T0), Day 3 (T1), Day 10, and Day 17 (T2)
Changes in Body Fat Percentage
Changes in body fat percentage measured by DEXA, expressed as a percentage.
Time frame: 8 weeks before the residential phase (T0), Day 3 (T1), Day 10, and Day 17 (T2)
Changes in HOMA-IR
Changes in insulin resistance estimated using HOMA-IR, calculated from fasting glucose and insulin concentrations. Unitless.
Time frame: 8 weeks before the residential phase (T0), Day 3 (T1), Day 10, and Day 17 (T2)
Changes in Fasting Plasma Glucose
Changes in fasting plasma glucose concentrations, expressed in mmol/L.
Time frame: 8 weeks before the residential phase (T0), Day 3 (T1), Day 10, and Day 17 (T2)
Changes in Fasting Insulin
Changes in fasting insulin concentrations measured at each study time point.
Time frame: 8 weeks before the residential phase (T0), Day 3 (T1), Day 10, and Day 17 (T2)
Changes in Leptin Concentrations
Changes in circulating leptin concentrations measured at each study time point.
Time frame: 8 weeks before the residential phase (T0), Day 3 (T1), Day 10, and Day 17 (T2)
Changes in Ghrelin Concentrations
Changes in circulating ghrelin concentrations measured at each study time point.
Time frame: 8 weeks before the residential phase (T0), Day 3 (T1), Day 10, and Day 17 (T2)
Changes in Adiponectin Concentrations
Changes in circulating adiponectin concentrations measured at each study time point.
Time frame: 8 weeks before the residential phase (T0), Day 3 (T1), Day 10, and Day 17 (T2)
Changes in Complex Attention Standard Score
Changes in the Complex Attention standard score assessed using CNS Vital Signs. Higher scores indicate better performance.
Time frame: 8 weeks before the residential phase (T0), Day 3 (T1), Day 10, and Day 17 (T2)
Changes in Reaction Time Standard Score
Changes in the Reaction Time domain standard score assessed using CNS Vital Signs. Higher scores indicate better performance.
Time frame: 8 weeks before the residential phase (T0), Day 3 (T1), Day 10, and Day 17 (T2)
Changes in 24-Hour Mean Systolic Blood Pressure
Changes in mean 24-hour systolic blood pressure measured by ambulatory blood pressure monitoring (ABPM), expressed in mmHg.
Time frame: 8 weeks before the residential phase (T0), Day 3 (T1), Day 10, and Day 17 (T2)
Changes in 24-Hour Mean Diastolic Blood Pressure
Changes in mean 24-hour diastolic blood pressure measured by ABPM, expressed in mmHg.
Time frame: 8 weeks before the residential phase (T0), Day 3 (T1), Day 10, and Day 17 (T2)
Changes in 24-Hour Mean Arterial Pressure
Changes in mean 24-hour arterial pressure measured or calculated from ABPM, expressed in mmHg.
Time frame: 8 weeks before the residential phase (T0), Day 3 (T1), Day 10, and Day 17 (T2)
Changes in 24-Hour Pulse Pressure
Changes in 24-hour pulse pressure calculated as systolic minus diastolic blood pressure, expressed in mmHg.
Time frame: 8 weeks before the residential phase (T0), Day 3 (T1), Day 10, and Day 17 (T2)
Changes in 24-Hour Mean Heart Rate
Changes in mean 24-hour heart rate measured by ambulatory monitoring, expressed in beats per minute.
Time frame: 8 weeks before the residential phase (T0), Day 3 (T1), Day 10, and Day 17 (T2)
Change in Body Weight
Changes in body weight measured at each study time point, expressed in kg.
Time frame: 8 weeks before the residential phase (T0), Day 3 (T1), Day 10, and Day 17 (T2)
Change in Waist Circumference
Changes in waist circumference measured at each study time point, expressed in cm.
Time frame: 8 weeks before the residential phase (T0), Day 3 (T1), Day 10, and Day 17 (T2)
Change in Hip Circumference
Changes in hip circumference measured at each study time point, expressed in cm.
Time frame: 8 weeks before the residential phase (T0), Day 3 (T1), Day 10, and Day 17 (T2)
Changes in Fasting C-Peptide
Changes in fasting C-peptide concentrations measured at each study time point.
Time frame: 8 weeks before the residential phase (T0), Day 3 (T1), Day 10, and Day 17 (T2)
Changes in 2-Hour Plasma Glucose
8 weeks before the residential phase (T0), Day 3 (T1), Day 10, and Day 17 (T2)
Time frame: Changes in 2-hour plasma glucose concentrations measured during the oral glucose tolerance test.
Changes in 2-Hour Insulin
Changes in 2-hour insulin concentrations measured during the oral glucose tolerance test.
Time frame: 8 weeks before the residential phase (T0), Day 3 (T1), Day 10, and Day 17 (T2)
Changes in 2-Hour C-Peptide
Changes in 2-hour C-peptide concentrations measured during the oral glucose tolerance test.
Time frame: 8 weeks before the residential phase (T0), Day 3 (T1), Day 10, and Day 17 (T2)
Changes in Hemoglobin A1c
Changes in HbA1c concentrations measured at each study time point, expressed as a percentage.
Time frame: 8 weeks before the residential phase (T0), Day 3 (T1), Day 10, and Day 17 (T2)
Changes in Cortisol Levels
Changes in circulating cortisol concentrations measured at each study time point.
Time frame: 8 weeks before the residential phase (T0), Day 3 (T1), Day 10, and Day 17 (T2)
Changes in Lipid Profile
Changes in lipid profile, including total cholesterol, triglycerides, high-density lipoprotein cholesterol, and low-density lipoprotein cholesterol, measured at each study time point. Concentrations are expressed in mmol/L.
Time frame: 8 weeks before the residential phase (T0), Day 3 (T1), Day 10, and Day 17 (T2)
Changes in Free Fatty Acid Levels
Changes in circulating free fatty acid concentrations measured at each study time point.
Time frame: 8 weeks before the residential phase (T0), Day 3 (T1), Day 10, and Day 17 (T2)
Changes in Executive Function Standard Score
Changes in the Executive Function standard score assessed using CNS Vital Signs. Higher scores indicate better performance.
Time frame: 8 weeks before the residential phase (T0), Day 3 (T1), Day 10, and Day 17 (T2)
Changes in Memory Standard Score
Changes in the Memory standard score assessed using CNS Vital Signs. Higher scores indicate better performance.
Time frame: 8 weeks before the residential phase (T0), Day 3 (T1), Day 10, and Day 17 (T2)
Changes in Cognitive Flexibility Standard Score
Changes in the Cognitive Flexibility standard score assessed using CNS Vital Signs. Higher scores indicate better performance.
Time frame: 8 weeks before the residential phase (T0), Day 3 (T1), Day 10, and Day 17 (T2)
No study locations are listed for this record.
Plan to share: No — Individual participant data will not be routinely shared with other researchers due to ethical, privacy, and institutional data management requirements. Data may be considered for sharing in a de-identified form upon appropriate review and approval by the principal investigator and relevant institutional authorities, where permitted by the informed consent and applicable regulations.
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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