Effects of Omega-3 on cholesterol and body composition in patients with high cholesterol
Effects of Omega-3 Polyenoic Acid on Blood Lipid, Inflammatory Factors and Body Composition in Patients with Hyperlipidemia
This study tests if taking Omega-3 supplements can help people with high cholesterol improve their cholesterol levels and body composition.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Peking Union Medical College Hospital Academic / other |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Trial ID | NCT05015348 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of Omega-3 polyunsaturated fatty acids (PUFA) on lipid levels, inflammatory markers, and body composition in patients diagnosed with hyperlipidemia. Participants will be randomly assigned to receive either Omega-3 PUFA or a placebo, with both groups receiving nutritional counseling for a low-fat diet. Assessments of lipids, inflammatory factors, weight, and body composition will be conducted at the beginning, middle, and end of the study to evaluate the intervention's effectiveness.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older diagnosed with hyperlipidemia according to specific clinical criteria.
Not a fit: Patients currently taking lipid-lowering medications or those with hyperlipidemia due to secondary causes may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new dietary intervention for managing high cholesterol levels and improving overall health in patients with hyperlipidemia.
How similar studies have performed: Previous studies have shown positive outcomes with Omega-3 PUFA in managing lipid levels, suggesting this approach may be effective.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Beijing, Beijing Municipality
- Peking Union Medical College Hospita — Beijing, Beijing Municipality, China (Recruiting)
Study contacts
- Study coordinator: Kang Yu, master
- Email: yuk1997@sina.com
- Phone: +8613801130457
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.