Actively Recruiting
Effects of Omega-3 Polyenoic Acid on Blood Lipid, Inflammatory Factors and Body Composition in Patients with Hyperlipidemia
Led by Peking Union Medical College Hospital · Updated on 2025-01-01
120
Participants Needed
1
Research Sites
43 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of Omega-3 polyunsaturated fatty acids (PUFA) on blood lipids, inflammatory factors, and body composition in patients diagnosed with hyperlipidemia. This study compares an intervention group receiving Omega-3 PUFA with a control group receiving a placebo. Both groups also receive nutritional counseling and education about a low-fat diet to support their health during the study. Participants in the intervention group will take 3.6 grams per day of fish oil containing Omega-3 PUFA (EPA+DHA), while the control group will receive a placebo made to look identical but containing palm oil. The study is randomized and blinded to ensure unbiased results. Assessments will take place before treatment, at the midpoint, and at the end of the study to monitor changes in lipids, inflammatory markers, weight, and body composition. During the study, researchers will measure triglycerides, cholesterol, LDL cholesterol, inflammatory markers such as TNF-alpha, hsCRP, and interleukin-6, as well as body weight and BMI over a three-month period. Secondary outcomes include adiponectin and leptin levels. Participants will have regular visits for these assessments, and their adherence to the treatment and diet will be monitored throughout the study duration.
CONDITIONS
Brief Title
Effects of Omega-3 PUFA on Lipids, Inflammatory Factors and Body Composition in Patients with Hyperlipidemia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female aged 18 years or older
- Diagnosed with hyperlipidemia meeting clinical criteria: triglycerides ≥1.7 mmol/L, or total cholesterol ≥5.2 mmol/L, or LDL cholesterol ≥3.4 mmol/L
- Fully understand and voluntarily sign the informed consent
- Able to eat orally
- Able to complete the study and follow researchers' instructions
You will not qualify if you...
- Currently taking lipid-lowering drugs
- Hyperlipidemia caused by secondary conditions such as nephrotic syndrome, hypothyroidism, renal failure, liver disease, systemic lupus erythematosus, glycogen storage disease, myeloma, fat atrophy, acute porphyria, polycystic ovary syndrome
- Use of diuretics, non-cardiac selective beta blockers, or glucocorticoids that may cause secondary dyslipidemia
- Severe internal or external diseases including heart, liver, kidney dysfunction, recent acute myocardial infarction, stroke, intracerebral hemorrhage, COPD attack, respiratory failure within 3 months
- Surgery within the last 3 months
- Hemorrhagic disease or bleeding tendency
- History of allergy to omega-3 polyenoic acid
- Pregnant or breastfeeding women
- Poor compliance or unable to complete follow-up
- Serious abnormal metabolism or need for further intervention making continuation unsuitable as judged by physician
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 3 months
Participants take either Omega-3 PUFA or placebo daily while receiving nutritional counseling and education for a low-fat diet. Lipids, inflammatory factors, weight, and body composition are assessed.
3 visits (beginning, middle, and end of treatment)
Trial Site Locations
Total: 1 location
1
Peking Union Medical College Hospita
Beijing, Beijing Municipality, China, 100730
Actively Recruiting
Research Team
K
Kang Yu, master
F
Fang Wang, master
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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