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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low dose group | Experimental | Low-dose omega-3 fatty acid supplementation, omega-3 fatty acids capsules, 1.5 grams per day for 1 year. |
|
| High dose group | Experimental | High-dose omega-3 fatty acid supplementation, omega-3 fatty acids capsules, 3 grams per day for 1 year. |
|
| Control group | Placebo Comparator | Control drug, matching placebo capsules, 3 grams per day for 1 year. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Low dose omega-3 fatty acid supplementation | Drug | Omega-3 fatty acids capsules, 1.5 g/d by mouth for 1 year |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in blood glucose from baseline | The investigators will measure HbA1c and fasting plasma glucose levels in blood samples before and after treatment. | 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. | 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). | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 months |
| Change in sleep quality |
| Measure | Description | Time Frame |
|---|---|---|
| Change in fecal metabolome | The investigators will collect fecal samples from every participant and the UPLC-MS/MS method will be used to analyze the fecal metabolomics profile. | 12 months |
| Change in urine metabolome |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lanxi Red Cross Hospital | Jinhua | Zhejiang | 321102 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41559698 | Derived | 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. | |
| 40347940 |
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| ID | Term |
|---|---|
| D006943 | Hyperglycemia |
| D006949 | Hyperlipidemias |
| D003924 | Diabetes Mellitus, Type 2 |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D050171 | Dyslipidemias |
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| ID | Term |
|---|---|
| D004335 | Drug and Narcotic Control |
| ID | Term |
|---|---|
| D007880 | Legislation, Drug |
| D007878 | Legislation as Topic |
| D012926 | Social Control, Formal |
| D004472 | Health Care Economics and Organizations |
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| High dose omega-3 fatty acid supplementation | Drug | Omega-3 fatty acids capsules, 3 g/d by mouth for 1 year |
|
|
| Control drug | Drug | Matching placebo capsules,3 g/d by mouth for 1 year |
|
|
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.
| 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. | 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). | 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. | 12 months |
| Change in urinary protein concentration | The investigators will collect urine sample from every participant and measure urinary protein before and after treatment. | 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. | 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. | 12 months |
The investigators will collect urine samples from every participant and the UPLC-MS/MS method will be used to analyze the urine metabolomics profile.
| 12 months |
| Derived |
| Zhuang 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. |
| D052439 | Lipid Metabolism Disorders |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010605 | Pharmacy Administration |
| D009934 | Organization and Administration |
| D006298 | Health Services Administration |