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| Name | Class |
|---|---|
| The First Affiliated Hospital with Nanjing Medical University | OTHER |
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The objective of this research was to investigate the impact of Omega-3 PUFAs on the gut microbiota and serum lipid metabolites in participants diagnosed with type 2 diabetes, employing high-throughput sequencing technology and untargeted lipidomics.
The pathogenesis of diabetes is associated with perturbations in lipid metabolism and intestinal flora. Nevertheless, the precise impact of Omega-3 polyunsaturated fatty acids (Omega-3 PUFAs) on key lipid metabolites, intestinal microorganisms, and fungi linked to type 2 diabetes remains indeterminate. The objective of this research was to investigate the impact of Omega-3 PUFAs on the gut microbiota and serum lipid metabolites in participants diagnosed with type 2 diabetes, employing high-throughput sequencing technology and untargeted lipidomics. The investigators randomly allocated 110 eligible participants into either the fish oil intervention group or the placebo control group for a 3-month double-blind randomized intervention trial. Bacterial 16S rDNA, fungal diversity analysis of Internally Transcribed Spacer sequences (ITS) and untargeted lipidomics were used to investigate the effects of Omega-3 PUFAs on intestinal microbiota and serum lipid metabolites.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| fish oil group | Experimental | Fish oil supplement capsules contained omega-3 polyunsaturated fatty acids supplied by Royal DSM Group, the Netherlands. Each 100 grams of fish oil capsules contains mainly 36.86 grams of EPA, 17.47 grams of DHA and other types of fatty acids. |
|
| The placebo group | Placebo Comparator | The placebo for fish oil contained corn oil (Each 100 grams of corn oil contained 45.64 grams of linoleic acid, 25.62 grams of oleic acid, 17.0 grams of palmitic acid, and other fatty acids). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| omega-3 polyunsaturated fatty acids | Dietary Supplement | Participants in the intervention group took fish oil capsules, 6 capsules per day, divided into two doses in the morning and two doses in the evening. |
| Measure | Description | Time Frame |
|---|---|---|
| Concentration of Serum triglycerides | physiological parameter | 12 weeks |
| Concentration of total cholesterol | physiological parameter | 12 weeks |
| Concentration of low-density lipoprotein cholesterol | physiological parameter | 12 weeks |
| Concentration of high-density lipoprotein cholesterol | physiological parameter | 12 weeks |
| weight in kilograms | physiological parameter | 12 weeks |
| height in meters | physiological parameter | 12 weeks |
| body mass index (BMI) | BMI=weight(kg)/height^2(m) | 12 weeks |
| waist circumference | physiological parameter | 12 weeks |
| hip measurement | physiological parameter | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants who take drugs | This indicator refers to the number of participants taking medication. | 12 weeks |
| Incidence of diabetes complications | This indicator refers to the proportion of participants experiencing complications from diabetes. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Southeast university | Nanjing | Jiangsu | 210000 | China |
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The study was a randomised, double-blind trial.
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The study was a randomised, double-blind trial, and neither the subjects nor the research workers knew the exact subgroups or the progress of the treatment
| corn oil | Dietary Supplement | Participants in the placebo group took corn oil capsules, 6 capsules per day, divided into two doses in the morning and two doses in the evening. |
|
| Systolic blood pressure | physiological parameter | 12 weeks |
| Diastolic blood pressure | physiological parameter | 12 weeks |
| 12 weeks |
| Rate of smoking among participants | This indicator refers to the proportion of participants who smoke. | 12 weeks |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D052439 | Lipid Metabolism Disorders |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D004281 | Docosahexaenoic Acids |
| D003314 | Corn Oil |
| ID | Term |
|---|---|
| D015525 | Fatty Acids, Omega-3 |
| D004042 | Dietary Fats, Unsaturated |
| D004041 | Dietary Fats |
| D005223 | Fats |
| D008055 | Lipids |
| D005231 | Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D005395 | Fish Oils |
| D009821 | Oils |
| D005224 | Fats, Unsaturated |
| D010938 | Plant Oils |
| D028321 | Plant Preparations |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
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