Effects of Omega-3 PUFA on Lipids, Inflammatory Factors and Body Composition in Patients with Hyperlipidemia
NCT ID: NCT05015348
Last Updated: 2025-01-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
120 participants
INTERVENTIONAL
2021-12-01
2024-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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O3A arm
participants of this arm will be provided with omega-3 PUFA
fish oil with omega-3 PUFA
3.6g per day fish oil with omega-3 PUFA (EPA+DHA)
placebo arm
participants of this arm will be provided with same amount of corn oil as placebo
placebo
palm oil as placebo
Interventions
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fish oil with omega-3 PUFA
3.6g per day fish oil with omega-3 PUFA (EPA+DHA)
placebo
palm oil as placebo
Eligibility Criteria
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Inclusion Criteria
* \[2\] 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
* \[2\] 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.
18 Years
ALL
No
Sponsors
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Peking Union Medical College Hospital
OTHER
Responsible Party
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Principal Investigators
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Kang Yu, master
Role: STUDY_DIRECTOR
Peking Union Medical College Hospital
Locations
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Peking Union Medical College Hospita
Beijing, Beijing Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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HS-2908
Identifier Type: -
Identifier Source: org_study_id
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