Clinical Trial

Effect of Omega-3 Supplementation on Fasting Triglycerides During Lifestyle Intervention in Adults With Mild-to-moderate Hypertriglyceridemia

Completed
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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.
Protocol Amendment History 4 changes
critical Trial completed 2026-07-30
critical Primary endpoint(s) modified 2026-07-30
notable Primary completion moved earlier: 2024-03-01 -> 2023-12-01 2026-07-30
minor Completion moved earlier: 2024-12-31 -> 2024-12-01 2026-07-30
Trial Details
NCT Number NCT05015348
Lead Sponsor Peking Union Medical College Hospital
Conditions Hyperlipidemias
Enrollment 127 participants
Start Date 2021-12-01
Primary Completion 2023-12-01 (estimated)
Study Completion 2024-12-01 (estimated)
Updated on ClinicalTrials.gov 2026-07-29