Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID05015348

Effects of Omega-3 Polyunsaturated Fatty Acids on Blood Lipids, 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

160 weeks

Total Duration

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AI-Summary

What this Trial Is About

This research focuses on patients with hyperlipidemia, a condition characterized by elevated blood lipids. It aims to evaluate the effects of Omega-3 polyunsaturated fatty acids (PUFA) on blood lipids, inflammatory factors, and body composition. Participants will be randomly assigned to either an intervention group receiving Omega-3 PUFA or a control group receiving a placebo, with all participants receiving nutritional counseling for a low-fat diet. 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 of palm oil that looks identical to the active treatment. The study is blinded and randomized, with pills distributed by an investigational pharmacist according to a randomization table. Lipid levels, inflammatory markers, body weight, and body composition will be assessed at the start, middle, and end of the study. Throughout the study, participants will have their triglycerides, cholesterol, LDL cholesterol, TNF-alpha, hsCRP, interleukin-6, body weight, and BMI measured at three months. Researchers will track these markers to understand changes during the study period. Nutritional counseling and education are provided to support adherence to a low-fat diet. The total length of participation is at least three months, including regular assessments and monitoring of health and treatment effects.

CONDITIONS

Official Title

Effects of Omega-3 PUFA on Lipids, Inflammatory Factors and Body Composition in Patients with Hyperlipidemia

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Male or female, 18 years old and above
  • 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 informed consent
  • Able to eat orally
  • Able to follow the research protocol and comply with doctor and researcher instructions
Not Eligible

You will not qualify if you...

  • Currently receiving 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, or use of certain medications causing secondary dyslipidemia
  • Severe diseases including heart, liver, kidney dysfunction, recent acute myocardial infarction, stroke, intracerebral hemorrhage, acute COPD attack, respiratory failure within 3 months; recent surgery within 3 months; or deemed unsuitable by clinician
  • Hemorrhagic disease or bleeding tendency
  • History of allergy to omega-3 polyenoic acid preparations
  • Pregnant or lactating women
  • Poor compliance or inability to complete follow-up
  • Serious abnormal metabolism or need for further intervention making continued participation unsuitable as assessed by physician

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Peking Union Medical College Hospita

Beijing, Beijing Municipality, China, 100730

Actively Recruiting

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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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