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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
127
1.788 g/day EPA and 0.630 g/day DHA per day.
the same amont of corn oil as placebo
Peking Union Medical College Hospita
Beijing, Beijing Municipality, China
percentage change of triglyceride
percentage change in fasting triglyceride from baseline to week 12
Time frame: From enrollment to the end of treatment at 12 weeks
insulin resistance
homeostatic model assessment of insulin resistance (HOMA-IR)
Time frame: 3 months
visceral fat area (VFA)
visceral fat area (VFA) in cm2
Time frame: 3 months
body weight
weight in kilogram
Time frame: 3 months
non-HDL-C
non-HDL-C in mmol/L
Time frame: 3 months
HDL-C
high-density lipoprotein cholesterol in mmol/L
Time frame: 3 months
longitudinal TG trajectory of triglycerides
longitudinal TG trajectory at weeks 6 and 12
Time frame: 6 weeks and 12 weeks of the study
low-density lipoprotein cholesterol (LDL-C),
changes in low-density lipoprotein cholesterol (LDL-C)
Time frame: 3 months
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