Hyperlipidemias
Conditions
Keywords
Hyperlipidemias, omega-3 PUFA
Brief summary
Patients with hyperlipidemia will be allocated to the intervention or control group randomly. Participants of the intervention group will be provided with Omega-3 PUFA, while participants of the control group will be provided with a placebo which looked same as the drug in the intervention group. During the study, all participants can have nutritional counseling and education for a healthy diet, such as energy restriction when appropriate, reduced saturated fat and refined carbohydrate intake, increased vegetables, whole grains, and dietary fiber, and avoidance of excessive alcohol intake. The lipids, inflammatory factors, weight, and body composition will be assessed and recorded before, at 6 weeks, and at 12 weeks of the study.
Detailed description
Randomization tables were generated by the statistician and provided to the investigational pharmacist who distributed the blinded capsules to participants. Participants of the intervention group will be provided with Omega-3 PUFA, while participants of the control group will be provided with a placebo. Participants in the omega-3 group took six fish-oil capsules daily. Each 600-mg fish-oil capsule contained 298 mg eicosapentaenoic acid (EPA) and 105 mg docosahexaenoic acid (DHA), providing 1.788 g/day EPA, 0.630 g/day DHA, and 2.418 g/day EPA plus DHA. The capsules were manufactured by Nuokang Biotechnology Co., Ltd. (China) and stored at room temperature. Participants in the placebo group received six visually identical corn oil capsules daily. Active and placebo capsules were identical in appearance, packaging, color, and labeling. During the study, all participants can have nutritional counseling and education for an energy-restricted and low-fat diet. The lipids, inflammatory factors, weight, and body composition will be assessed and recorded before, in the middle, and at the end of the study.
Interventions
DIETARY_SUPPLEMENTOmega-3 PUFA supplementation
1.788 g/day EPA and 0.630 g/day DHA per day.
OTHERplacebo
the same amont of corn oil as placebo
Sponsors
Peking Union Medical College Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 79 Years
Healthy volunteers
No
Inclusion criteria
* \[1\] Gender and age: male or female, 18 years old and above. * \[2\] Patients were diagnosed with hyperlipidemia. According to the definition of the 2016 guidelines for the prevention and treatment of dyslipidemia in Chinese adults, it meets the clinical diagnostic criteria of mild-moderate hyperlipidemia: hypertriglyceridemia \[TG 1.7-5.4mmol/L\]; Or mixed with TC≥5.2mmol/L\]; Or mixed with LDL-C≥3.4mmol/L\]. * \[3\] Before the study, the subjects fully understood and voluntarily signed the informed consent form, and fully understood the research content, process, and possible adverse reactions. * \[4\] Those who can eat orally. * \[5\] Be able to complete the research according to the requirements of the research protocol and obey the arrangements of doctors and researchers.
Exclusion criteria
* \[1\] Those who are receiving lipid-lowering drugs. * \[2\] Hyperlipidemia caused by secondary causes, such as nephrotic syndrome, hypothyroidism, renal failure, liver disease, systemic lupus erythematosus, glycogen accumulation, myeloma, fat atrophy, acute porphyria, polycystic ovary syndrome, etc; Use diuretics, non-cardiac selective β-receptor blockers, and glucocorticoids, which may cause secondary dyslipidemia. * \[3\] Patients with severe internal and external diseases, such as heart, liver, and kidney dysfunction, acute myocardial infarction, stroke, intracerebral hemorrhage, acute attack of COPD, respiratory failure, etc., in recent 3 months, patients who have undergone surgery in the past 3 months, or any person who is not suitable to participate in this study after clinician evaluation. * \[4\] Have hemorrhagic disease or bleeding tendency. * \[5\] Those who have a history of allergy to omega-3 polyenoic acid preparation. * \[6\] Pregnant and lactating women. * \[7\] Poor compliance, unable to follow up on time or unable to complete the follow-up of medication. * \[8\] In the course of diagnosis and treatment, if there is any seriously abnormal metabolism or further intervention is needed, or the patient is no longer suitable for continuing the study through the assessment of the competent physician, he can withdraw from the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| percentage change of triglyceride | From enrollment to the end of treatment at 12 weeks | percentage change in fasting triglyceride from baseline to week 12 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| insulin resistance | 3 months | homeostatic model assessment of insulin resistance (HOMA-IR) |
| visceral fat area (VFA) | 3 months | visceral fat area (VFA) in cm2 |
| body weight | 3 months | weight in kilogram |
| non-HDL-C | 3 months | non-HDL-C in mmol/L |
| HDL-C | 3 months | high-density lipoprotein cholesterol in mmol/L |
| longitudinal TG trajectory of triglycerides | 6 weeks and 12 weeks of the study | longitudinal TG trajectory at weeks 6 and 12 |
| low-density lipoprotein cholesterol (LDL-C), | 3 months | changes in low-density lipoprotein cholesterol (LDL-C) |
Countries
China
Contacts
STUDY_DIRECTORKang Yu, master
Peking Union Medical College Hospital
Outcome results
None listed