Hyperglycaemia (Diabetic)NCT03708887
The Effect of Omega-3 FA on Glucose and Lipid Homeostasis Disorders in Obese/Diabetic Patients
A study testing Low dose omega-3 fatty acid supplementation and High dose omega-3 fatty acid supplementation in people with Hyperglycaemia (Diabetic) and Hyperlipidemias, run by Zhejiang University at 1 site in China.
Trial summary
A double-blind and placebo-controlled study is conducted in the current human study. The purpose of this study is to investigate the effects of n-3 PUFA intervention on glucose and lipid homeostasis in Chinese diabetic/obese patients. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Hyperglycaemia (Diabetic), Hyperlipidemias
- What is being tested?
- Low dose omega-3 fatty acid supplementation and High dose omega-3 fatty acid supplementation
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 415 participants
- Where
- 1 siteChina
- Study dates
- 10 Oct 2020to 28 Feb 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed type 2 diabetes for diabetic groups according to WHO diagnostic criteria;
- BMI≥28 for obese groups;
- Aged between 40 and 75 years.
Who cannot join
- Type 1 diabetes;
- Cardiovascular disease;
- Cancer;
- Liver or kidney disease;
- Premenopausal women, pregnancy or lactation;
- Allergy to fish;
- Have participated in other clinical trials in the last three months.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Double-blind and Placebo-controlled Study on Intervention Effect of n-3 Fatty Acids on Glucose and Lipid Homeostasis Disorders in Obese/Diabetic Populations
A double-blind and placebo-controlled study is conducted in the current human study.
The purpose of this study is to investigate the effects of n-3 PUFA intervention on glucose and lipid homeostasis in Chinese diabetic/obese patients.
Read the detailed description
Approximately 450 diabetic and 450 obese patients will be enrolled from Lanxi in China. They will be randomly assigned into one of the following three groups: Omega-3 fatty acids capsules (1.5 g/d); or omega-3 fatty acids capsules (3 g/d); or placebo capsules. Blood, feces and urine samples will be collected before and after treatment. Glucose and lipid parameters will be measured. Diabetes comorbidities and complications will also be assessed. This study will also explore the new mechanisms of n-3 PUFAs on improving glucose and lipid homeostasis and other outcomes based on multi-omics and establish a model for precision intervention.
- Conditions
- Hyperglycaemia (Diabetic), Hyperlipidemias
- Being tested
- Low dose omega-3 fatty acid supplementation, High dose omega-3 fatty acid supplementation, Control drug
- Keywords
- Type 2 diabetes, Obesity, Omega-3 fatty acids
- Medical subject headings
- Hyperglycemia, Hyperlipidemias, Diabetes Mellitus, Type 2, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low dose omega-3 fatty acid supplementationDrug
Also called Fish oil supplement
Omega-3 fatty acids capsules, 1.5 g/d by mouth for 1 year
High dose omega-3 fatty acid supplementationDrug
Also called Fish oil supplement
Omega-3 fatty acids capsules, 3 g/d by mouth for 1 year
Control drugDrug
Also called Placebo drug
Matching placebo capsules,3 g/d by mouth for 1 year
| Study group | Role | What they receive |
|---|---|---|
| Low dose group | Experimental | Low-dose omega-3 fatty acid supplementation, omega-3 fatty acids capsules, 1.5 grams per day for 1 year. Receives: Drug: Low dose omega-3 fatty acid supplementation |
| High dose group | Experimental | High-dose omega-3 fatty acid supplementation, omega-3 fatty acids capsules, 3 grams per day for 1 year. Receives: Drug: High dose omega-3 fatty acid supplementation |
| Control group | Placebo comparator | Control drug, matching placebo capsules, 3 grams per day for 1 year. Receives: Drug: Control drug |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in blood glucose from baseline
The investigators will measure HbA1c and fasting plasma glucose levels in blood samples before and after treatment.
Measured: 12 months
Change in blood lipids from baseline
The investigators will measure Triglycerides (TG), total cholesterol (TC), LDL-C, and HDL-C levels in blood samples before and after treatment.
Measured: 12 months
Change in carotid plaque and carotid intima-meida thickness
A FUJIFILM SonoSite ultrasound system will be used to assess carotid artery plaque lesions and measure carotid intima-media thickness (CIMT).
Measured: 12 months
Secondary outcomes (8)
Change in gut microbiota from baseline
The investigators will collect faeces sample from every participants and 16S rDNA sequencing will be used to analyze the composition of gut microbiota.
Measured: 12 months
Change in sleep quality
The investigators will measure the Pittsburgh Sleep Quality Index (PSQI) through face-to-face questionnaire before and after treatment. The PSQI ranges from 0 to 21, with a higher score indicating a worse sleep quality.
Measured: 12 months
Change in cognitive function
The investigators will do the mini-mental state examination (MMSE) before and after treatment. The MMSE score ranges from 0 to 30, with higher scores indicative of superior cognitive functioning.
Measured: 12 months
Change in bone mineral density (BMD)
The whole body of the patient will be scanned and analyzed by a whole-body dual-energy X-ray absorptiometry (DXA) to measure the bone mineral density (BMD).
Measured: 12 months
Change in body fat distribution
The whole body of the patient will be scanned and analyzed by a whole-body dual-energy X-ray absorptiometry (DXA) to measure the total and regional body fat mass (FM) and then percentages of regional body fat will be calculated.
Measured: 12 months
Change in urinary protein concentration
The investigators will collect urine sample from every participant and measure urinary protein before and after treatment.
Measured: 12 months
Change in estimated glomerular filtration rate (eGFR)
The investigators will collect blood sample from every participant and measure blood creatinine before and after treatment. The Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation will be used to calculate the eGFR.
Measured: 12 months
Change in blood metabolome
The investigators will collect blood samples from every participant and the UPLC-MS/MS method will be used to analyze the blood metabolomics profile.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2018
- Study start10 Oct 2020
- Primary completion2 Jan 2022
- Study completion28 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Hyperglycaemia (Diabetic)Studies of the same condition, open and under way.
- More trials run by Zhejiang UniversityThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 415 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zhejiang University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jingjing Jiao, Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03708887
- Sponsor's protocol ID
- RCT-N3
- Status last verified
- Apr 2024
- First submitted
- 14 Oct 2018
- Last updated
- 12 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zhuang P, Liu X, Jia W, Zheng W, Wan X, Chen W, Gu J, Li Y, Lan X, Li H, Tong W, Wu Y, Wu X, Ao Y, Ye H, Wu F, Zhu L, Zhang L, Li Y, Meng D, Tian Y, Wang A, Wu S, Zhu F, Zhang Y, Shi H, Yu X, Zhang F, Zhang Y, Jiao J. Marine n-3 fatty acid treatment for carotid plaques in patients with type 2 diabetes. Cardiovasc Diabetol. 2026 Jan 20;25(1):52. doi: 10.1186/s12933-026-03082-7.
PubMed 41559698Zhuang P, Wu Y, Yao J, Liu X, Liu H, Wan X, Jia W, Wang T, Zhang Y, Jiao J. Marine n-3 polyunsaturated fatty acids slow sleep impairment progression by regulating central circadian rhythms in type 2 diabetes. Cell Rep Med. 2025 May 20;6(5):102128. doi: 10.1016/j.xcrm.2025.102128. Epub 2025 May 9.
PubMed 40347940
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-blind and Placebo-controlled Study on Intervention Effect of n-3 Fatty Acids on Glucose and Lipid Homeostasis Disorders in Obese/Diabetic Populations
- ClinicalTrials.gov ID
- NCT03708887
- Acronym / sponsor ID
- RCT-N3
- Conditions
- Hyperglycaemia (Diabetic), Hyperlipidemias
- Keywords
- Type 2 diabetes, Obesity, Omega-3 fatty acids
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 415 participants (actual)
- Lead sponsor
- Zhejiang UniversityUniversity, hospital or other
- Study start
- 10 Oct 2020 (actual)
- Primary completion
- 2 Jan 2022 (actual)
- Study completion
- 28 Feb 2022 (actual)
- First posted
- 17 Oct 2018 (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.
A double-blind and placebo-controlled study is conducted in the current human study.
The purpose of this study is to investigate the effects of n-3 PUFA intervention on glucose and lipid homeostasis in Chinese diabetic/obese patients.
Detailed description
Approximately 450 diabetic and 450 obese patients will be enrolled from Lanxi in China. They will be randomly assigned into one of the following three groups: Omega-3 fatty acids capsules (1.5 g/d); or omega-3 fatty acids capsules (3 g/d); or placebo capsules. Blood, feces and urine samples will be collected before and after treatment. Glucose and lipid parameters will be measured. Diabetes comorbidities and complications will also be assessed. This study will also explore the new mechanisms of n-3 PUFAs on improving glucose and lipid homeostasis and other outcomes based on multi-omics and establish a model for precision intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Low dose group | Experimental | Drug: Low dose omega-3 fatty acid supplementationLow-dose omega-3 fatty acid supplementation, omega-3 fatty acids capsules, 1.5 grams per day for 1 year. |
| High dose group | Experimental | Drug: High dose omega-3 fatty acid supplementationHigh-dose omega-3 fatty acid supplementation, omega-3 fatty acids capsules, 3 grams per day for 1 year. |
| Control group | Placebo comparator | Drug: Control drugControl drug, matching placebo capsules, 3 grams per day for 1 year. |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosed type 2 diabetes for diabetic groups according to WHO diagnostic criteria;
- BMI≥28 for obese groups;
- Aged between 40 and 75 years.
Key exclusion criteria (7 listed)
- Type 1 diabetes;
- Cardiovascular disease;
- Cancer;
- Liver or kidney disease;
- Premenopausal women, pregnancy or lactation;
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 |
|---|---|---|
| Low dose omega-3 fatty acid supplementationAlso: Fish oil supplementOmega-3 fatty acids capsules, 1.5 g/d by mouth for 1 year | Drug | Low dose group |
| High dose omega-3 fatty acid supplementationAlso: Fish oil supplementOmega-3 fatty acids capsules, 3 g/d by mouth for 1 year | Drug | High dose group |
| Control drugAlso: Placebo drugMatching placebo capsules,3 g/d by mouth for 1 year | Drug | Control group |
Primary outcome
Change in blood glucose from baseline
Time frame: 12 months
The investigators will measure HbA1c and fasting plasma glucose levels in blood samples before and after treatment.
Change in blood lipids from baseline
Time frame: 12 months
The investigators will measure Triglycerides (TG), total cholesterol (TC), LDL-C, and HDL-C levels in blood samples before and after treatment.
Change in carotid plaque and carotid intima-meida thickness
Time frame: 12 months
A FUJIFILM SonoSite ultrasound system will be used to assess carotid artery plaque lesions and measure carotid intima-media thickness (CIMT).
8 secondary outcomes
Change in gut microbiota from baseline
Time frame: 12 months
Change in sleep quality
Time frame: 12 months
Change in cognitive function
Time frame: 12 months
Change in bone mineral density (BMD)
Time frame: 12 months
Change in body fat distribution
Time frame: 12 months
Change in urinary protein concentration
Time frame: 12 months
Change in estimated glomerular filtration rate (eGFR)
Time frame: 12 months
Change in blood metabolome
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2024.
- Derived from this study: PubMed 41559698Zhuang P, Liu X, Jia W, Zheng W, Wan X, Chen W, Gu J, Li Y, Lan X, Li H, Tong W, Wu Y, Wu X, Ao Y, Ye H, Wu F, Zhu L, Zhang L, Li Y, Meng D, Tian Y, Wang A, Wu S, Zhu F, Zhang Y, Shi H, Yu X, Zhang F, Zhang Y, Jiao J. Marine n-3 fatty acid treatment for carotid plaques in patients with type 2 diabetes. Cardiovasc Diabetol. 2026 Jan 20;25(1):52. doi: 10.1186/s12933-026-03082-7.
- Derived from this study: PubMed 40347940Zhuang P, Wu Y, Yao J, Liu X, Liu H, Wan X, Jia W, Wang T, Zhang Y, Jiao J. Marine n-3 polyunsaturated fatty acids slow sleep impairment progression by regulating central circadian rhythms in type 2 diabetes. Cell Rep Med. 2025 May 20;6(5):102128. doi: 10.1016/j.xcrm.2025.102128. Epub 2025 May 9.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low dose omega-3 fatty acid supplementation and High dose omega-3 fatty acid supplementation in people with Hyperglycaemia (Diabetic) and Hyperlipidemias, run by Zhejiang University at 1 site in China.
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 3 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: finished, as of the sponsor's last update on 12 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in blood glucose from baseline (time frame: 12 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03708887, which also lists 2 linked publications.
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 12 Jul 2024.