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

Effects of Omega-3 Polyenoic Acid on Blood Lipid, Inflammatory Factors and Body Composition in Patients with Hyperlipidemia

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.

Study Overview

• Status: Recruiting
• Conditions: Hyperlipidemias
• Intervention / Treatment: Other: fish oil with omega-3 PUFA; Other: placebo

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 Type: Interventional
• Enrollment (Estimated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Fang Wang, master; Phone Number: +8615201646084; Email: yours.fang@Hotmail.com
• Study Contact Backup: Name: Kang Yu, master; Phone Number: +8613801130457; Email: yuk1997@sina.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100730
      • Recruiting
      • Peking Union Medical College Hospita
      • Contact: Kang Yu, MD; Phone Number: +8613801130457; Email: yuk1997@sina.com
      • Contact: Fang Wang, MD, MS; Phone Number: +8615201646084; Email: yours.fang@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: O3A arm; participants of this arm will be provided with omega-3 PUFA	Other: fish oil with omega-3 PUFA; 3.6g per day fish oil with omega-3 PUFA (EPA+DHA)
Placebo Comparator: placebo arm; participants of this arm will be provided with same amount of corn oil as placebo	Other: placebo; palm oil as placebo

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
adiponectin	adiponectin in μg/mL	3 months
leptin	leptin in μg/mL	3 months

Collaborators and Investigators

• Sponsor: Peking Union Medical College Hospital
• Investigators: Study Director: Kang Yu, master, Peking Union Medical College Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2021
• Primary Completion (Actual): March 1, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: July 24, 2021
• First Submitted That Met QC Criteria: August 15, 2021
• First Posted (Actual): August 20, 2021

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 30, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Dyslipidemias; Lipid Metabolism Disorders; Hyperlipidemias; Hyperlipoproteinemias
• Other Study ID Numbers: HS-2908

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No