Sleep DeprivationNCT07897097
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)
A study testing n-3 PUFA Supplementation and Experimental Sleep Restriction in people with Sleep Deprivation, run by Beijing Anzhen Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep Deprivation
- What is being tested?
- n-3 PUFA Supplementation and Experimental Sleep Restriction
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Dec 2026to Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
- 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.
- 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).
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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.
Read the detailed description
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.
- Conditions
- Sleep Deprivation
- Being tested
- n-3 PUFA Supplementation, Placebo Supplementation, Experimental Sleep Restriction
- Keywords
- Sleep Restriction, Visceral Adipose Tissue, Omega-3 Fatty Acids, Gut Microbiota, Metabolic Changes, Inflammation
- Medical subject headings
- Sleep Deprivation, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
n-3 PUFA SupplementationDietary supplement
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 SupplementationDietary supplement
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 RestrictionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| n-3 PUFA Group | Experimental | 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. Receives: Dietary Supplement: n-3 PUFA Supplementation; Behavioral: Experimental Sleep Restriction |
| Placebo Group | Placebo comparator | 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. Receives: Dietary Supplement: Placebo Supplementation; Behavioral: Experimental Sleep Restriction |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 3 (T1) and Day 17 (T2)
Secondary outcomes (46)
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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 8 weeks before the residential phase (T0), Day 3 (T1), Day 10, and Day 17 (T2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2026
- Study startDec 2026 (estimated)
- Primary completionOct 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep DeprivationStudies of the same condition, open and under way.
- More trials run by Beijing Anzhen HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Anzhen Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jiang Xie, Principal investigator, Beijing Anzhen Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07897097
- Sponsor's protocol ID
- KS2026193
- Other IDs
- L2510016
- Status last verified
- Oct 2026
- First submitted
- 16 Oct 2026
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT07897097
- Acronym / sponsor ID
- KS2026193
- Conditions
- Sleep Deprivation
- Keywords
- Sleep Restriction, Visceral Adipose Tissue, Omega-3 Fatty Acids, Gut Microbiota, Metabolic Changes, Inflammation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Beijing Anzhen HospitalUniversity, hospital or other
- Study start
- Dec 2026 (estimated)
- Primary completion
- Oct 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 27 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| n-3 PUFA Group | Experimental | Dietary Supplement: n-3 PUFA Supplementation, Behavioral: Experimental Sleep RestrictionParticipants 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 Group | Placebo comparator | Dietary Supplement: Placebo Supplementation, Behavioral: Experimental Sleep RestrictionParticipants 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. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
- Obesity (BMI ≥28 kg/m²).
- Current smoking.
- Pregnancy or breastfeeding, menopause, or current use of oral contraceptives.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| n-3 PUFA SupplementationParticipants 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 Group |
| Placebo SupplementationParticipants 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 Group |
| Experimental Sleep RestrictionAll 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. | Behavioural | Placebo Group, n-3 PUFA Group |
Primary outcome
Change in Visceral Adipose Tissue Area
Time frame: Day 3 (T1) and Day 17 (T2)
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.
46 secondary outcomes
Change in Subcutaneous Adipose Tissue Area
Time frame: Day 3 (T1) and Day 17 (T2)
Change in Total Abdominal Adipose Tissue Area
Time frame: Day 3 (T1) and Day 17 (T2)
Change in Visceral-to-Subcutaneous Adipose Tissue Ratio
Time frame: Day 3 (T1) and Day 17 (T2)
Changes in Gut Microbial Alpha Diversity (Shannon Index)
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)
Time frame: 8 weeks before the residential phase (T0), Day 3 (T1), Day 10, and Day 17 (T2)
Changes in Gut Microbial Taxonomic Abundance
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
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
Time frame: 8 weeks before the residential phase (T0), Day 3 (T1), Day 10, and Day 17 (T2)
Changes in Interleukin-6 Levels
Time frame: 8 weeks before the residential phase (T0), Day 3 (T1), Day 10, and Day 17 (T2)
Changes in Interleukin-10 Levels
Time frame: 8 weeks before the residential phase (T0), Day 3 (T1), Day 10, and Day 17 (T2)
Changes in Interleukin-18 Levels
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
Time frame: 8 weeks before the residential phase (T0), Day 3 (T1), Day 10, and Day 17 (T2)
Changes in Interleukin-1 Beta Levels
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
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
Time frame: Day 3 (T1) and Day 17 (T2)
Changes in Adipose Tissue UCP1 Protein Expression
Time frame: Day 3 (T1) and Day 17 (T2)
Changes in Total Body Fat Mass
Time frame: 8 weeks before the residential phase (T0), Day 3 (T1), Day 10, and Day 17 (T2)
Changes in Lean Body Mass
Time frame: 8 weeks before the residential phase (T0), Day 3 (T1), Day 10, and Day 17 (T2)
Changes in Body Fat Percentage
Time frame: 8 weeks before the residential phase (T0), Day 3 (T1), Day 10, and Day 17 (T2)
Changes in HOMA-IR
Time frame: 8 weeks before the residential phase (T0), Day 3 (T1), Day 10, and Day 17 (T2)
Changes in Fasting Plasma Glucose
Time frame: 8 weeks before the residential phase (T0), Day 3 (T1), Day 10, and Day 17 (T2)
Changes in Fasting Insulin
Time frame: 8 weeks before the residential phase (T0), Day 3 (T1), Day 10, and Day 17 (T2)
Changes in Leptin Concentrations
Time frame: 8 weeks before the residential phase (T0), Day 3 (T1), Day 10, and Day 17 (T2)
Changes in Ghrelin Concentrations
Time frame: 8 weeks before the residential phase (T0), Day 3 (T1), Day 10, and Day 17 (T2)
Changes in Adiponectin Concentrations
Time frame: 8 weeks before the residential phase (T0), Day 3 (T1), Day 10, and Day 17 (T2)
Changes in Complex Attention Standard Score
Time frame: 8 weeks before the residential phase (T0), Day 3 (T1), Day 10, and Day 17 (T2)
Changes in Reaction Time Standard Score
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
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
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
Time frame: 8 weeks before the residential phase (T0), Day 3 (T1), Day 10, and Day 17 (T2)
Changes in 24-Hour Pulse Pressure
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
Time frame: 8 weeks before the residential phase (T0), Day 3 (T1), Day 10, and Day 17 (T2)
Change in Body Weight
Time frame: 8 weeks before the residential phase (T0), Day 3 (T1), Day 10, and Day 17 (T2)
Change in Waist Circumference
Time frame: 8 weeks before the residential phase (T0), Day 3 (T1), Day 10, and Day 17 (T2)
Change in Hip Circumference
Time frame: 8 weeks before the residential phase (T0), Day 3 (T1), Day 10, and Day 17 (T2)
Changes in Fasting C-Peptide
Time frame: 8 weeks before the residential phase (T0), Day 3 (T1), Day 10, and Day 17 (T2)
Changes in 2-Hour Plasma Glucose
Time frame: Changes in 2-hour plasma glucose concentrations measured during the oral glucose tolerance test.
Changes in 2-Hour Insulin
Time frame: 8 weeks before the residential phase (T0), Day 3 (T1), Day 10, and Day 17 (T2)
Changes in 2-Hour C-Peptide
Time frame: 8 weeks before the residential phase (T0), Day 3 (T1), Day 10, and Day 17 (T2)
Changes in Hemoglobin A1c
Time frame: 8 weeks before the residential phase (T0), Day 3 (T1), Day 10, and Day 17 (T2)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
- Individual participant dataSharing planned: 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.
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Healthy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jiang Xie principal investigator
Beijing Anzhen Hospital
Questions about this trial
What is this clinical trial studying?
A study testing n-3 PUFA Supplementation and Experimental Sleep Restriction in people with Sleep Deprivation, run by Beijing Anzhen Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yuting Zhang (+8613407059715, yuting07192000@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Visceral Adipose Tissue Area (time frame: Day 3 (T1) and Day 17 (T2)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2026.