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Patients with hyperlipidemia will be allocated into intervention or control group randomly. Participants of intervention group will be provided with Omega-3 PUFA, while participants of control group will be provided with placebo which looked same as the drug of intervention group. During the study, all participants can have nutritional counseling and education for low-fat diet. The lipids, inflammatory factors, weight, and body composition will be assessed and recorded before, at the middle, and end of the study.
Randomization tables were generated by the statistician and provided to the investigational pharmacist who distributed the blinded pills to participants.
Participants of intervention group will be provided with Omega-3 PUFA, while participants of control group will be provided with placebo which looked same as the drug of intervention group. During the study, all participants can have nutritional counseling and education for low-fat diet. The lipids, inflammatory factors, weight, and body composition will be assessed and recorded before, at the middle, and end of the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| O3A arm | Experimental | participants of this arm will be provided with omega-3 PUFA |
|
| placebo arm | Placebo Comparator | participants of this arm will be provided with same amount of corn oil as placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| fish oil with omega-3 PUFA | Other | 3.6g per day fish oil with omega-3 PUFA (EPA+DHA) |
| |
| Measure | Description | Time Frame |
|---|---|---|
| triglyceride | triglyceride in mmol/L | 3 months |
| cholesterol | cholesterol in mmol/L | 3 months |
| LDL-C | LDL-C in mmol/L | 3 months |
| TNF-α | TNF-α in ng/ml | 3 months |
| hsCRP | hsCRP in mmol/L | 3 months |
| interlukin-6 | IL-6 in ng/ml | 3 months |
| body weight | weight in kilogram | 3 months |
| BMI | BMI in kg/m2 | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| adiponectin | adiponectin in μg/mL | 3 months |
| leptin | leptin in μg/mL | 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kang Yu, master | Contact | +8613801130457 | yuk1997@sina.com | |
| Fang Wang, master | Contact | +8615201646084 | yours.fang@Hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Kang Yu, master | Peking Union Medical College Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking Union Medical College Hospita | Recruiting | Beijing | Beijing Municipality | 100730 | China |
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| ID | Term |
|---|---|
| D006949 | Hyperlipidemias |
| ID | Term |
|---|---|
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D005395 | Fish Oils |
| D004281 | Docosahexaenoic Acids |
| ID | Term |
|---|---|
| D009821 | Oils |
| D008055 | Lipids |
| D015525 | Fatty Acids, Omega-3 |
| D004042 | Dietary Fats, Unsaturated |
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| placebo |
| Other |
palm oil as placebo |
|
| D004041 |
| Dietary Fats |
| D005223 | Fats |
| D005231 | Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |