NCT05015348 Effects of Omega-3 PUFA on Lipids, Inflammatory Factors and Body Composition in Patients with Hyperlipidemia
| NCT ID | NCT05015348 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Peking Union Medical College Hospital |
| Condition | Hyperlipidemias |
| Study Type | INTERVENTIONAL |
| Enrollment | 120 participants |
| Start Date | 2021-12-01 |
| Primary Completion | 2024-03-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 120 participants in total. It began in 2021-12-01 with a primary completion date of 2024-03-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Patients with hyperlipidemia will be allocated into intervention or control group randomly. Participants of intervention group will be provided with Omega-3 PUFA, while participants of control group will be provided with placebo which looked same as the drug of intervention group. During the study, all participants can have nutritional counseling and education for low-fat diet. The lipids, inflammatory factors, weight, and body composition will be assessed and recorded before, at the middle, and end of the study.
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.
Contact & Investigator
Kang Yu, master
STUDY DIRECTOR
Peking Union Medical College Hospital
Frequently Asked Questions
Who can join the NCT05015348 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Hyperlipidemias. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05015348 currently recruiting?
Yes, NCT05015348 is actively recruiting participants. Contact the research team at yuk1997@sina.com for enrollment information.
Where is the NCT05015348 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT05015348 clinical trial?
NCT05015348 is sponsored by Peking Union Medical College Hospital. The principal investigator is Kang Yu, master at Peking Union Medical College Hospital. The trial plans to enroll 120 participants.