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

Not Applicable

Recruiting

• Conditions: Hyperlipidemias
• Interventions: Other: fish oil with omega-3 PUFA; Other: placebo

• Registration Number: NCT05015348
• Lead Sponsor: Peking Union Medical College Hospital

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.

Detailed Description

Randomization tables were generated by the statistician and provided to the investigational pharmacist who distributed the blinded pills to participants.

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.

Study Timeline

• Study First Submitted: 2021-07-24
• Study First Submitted QC: 2021-08-15
• Study First Posted: 2021-08-20
• Study Start: 2021-12-01
• Primary Completion: 2024-03-01
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-30
• Study Completion: 2024-12-31
• Last Update Posted: 2025-01-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 120

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
O3A arm	fish oil with omega-3 PUFA	participants of this arm will be provided with omega-3 PUFA
placebo arm	placebo	participants of this arm will be provided with same amount of palm oil as placebo

Primary Outcome Measures

Name	Time	Method
triglyceride	3 months	triglyceride in mmol/L
cholesterol	3 months	cholesterol in mmol/L
LDL-C	3 months	LDL-C in mmol/L
TNF-α	3 months	TNF-α in ng/ml
hsCRP	3 months	hsCRP in mmol/L
interlukin-6	3 months	IL-6 in ng/ml
body weight	3 months	weight in kilogram
BMI	3 months	BMI in kg/m2

Secondary Outcome Measures

Name	Time	Method
leptin	3 months	leptin in μg/mL
adiponectin	3 months	adiponectin in μg/mL

Trial Locations

Locations (1)

Peking Union Medical College Hospita; 🇨🇳 Beijing, Beijing, China