Effect of Omega-3 Supplementation on Fasting Triglycerides During Lifestyle Intervention in Adults With Mild-to-moderate Hypertriglyceridemia: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 127
- 试验地点
- 1
- 主要终点
- percentage change of triglyceride
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •[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.
排除标准
- •[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.
研究组 & 干预措施
placebo arm
Participants of this arm will be provided with the same amount of corn oil as the placebo, which is identical in appearance, packaging, color, and labeling.
干预措施: placebo (Other)
omega-3 arm
participants of this arm will be provided with omega-3 PUFA, which contains 1.788 g/day EPA and 0.630 g/day DHA per day.
干预措施: Omega-3 PUFA supplementation (Dietary Supplement)
结局指标
主要结局
percentage change of triglyceride
时间窗: From enrollment to the end of treatment at 12 weeks
percentage change in fasting triglyceride from baseline to week 12
次要结局
- HDL-C(3 months)
- insulin resistance(3 months)
- visceral fat area (VFA)(3 months)
- body weight(3 months)
- non-HDL-C(3 months)
- longitudinal TG trajectory of triglycerides(6 weeks and 12 weeks of the study)
- low-density lipoprotein cholesterol (LDL-C),(3 months)