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

Launched by PEKING UNION MEDICAL COLLEGE HOSPITAL · Aug 15, 2021

Keywords

ClinConnect Summary

This clinical trial is studying the effects of Omega-3 fatty acids on patients with high levels of fats in the blood, a condition known as hyperlipidemia. Participants will be randomly placed into two groups: one will receive Omega-3 supplements, while the other will receive a placebo, which looks the same but does not contain the active ingredient. All participants will also receive guidance on following a low-fat diet. Throughout the study, researchers will check and record important health measurements, including levels of fats in the blood, inflammation markers, weight, and overall body composition at the beginning, middle, and end of the trial.

To be eligible for this trial, you must be at least 18 years old and diagnosed with hyperlipidemia, meaning your blood tests show high levels of fats like triglycerides or cholesterol. However, if you are currently taking medication to lower blood fats or have certain medical conditions that can affect fat levels, you may not qualify. Participants can expect to receive nutritional support and will need to attend follow-up appointments to monitor their health throughout the study. This research aims to better understand how Omega-3 supplements can help manage high blood fat levels and improve overall health.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • \[1\] Gender and age: male or female, 18 years old and above.
• • \[2\] Patients were diagnosed with hyperlipidemia. According to the definition of 2016 guidelines for the prevention and treatment of dyslipidemia in Chinese adults, it meets the clinical diagnostic criteria of hyperlipidemia: hypertriglyceridemia \[TG≥1.7mmol/L\]; 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.
• Exclusion Criteria:
• • \[1\] 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 recent 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.