Effect of Omega-3 Supplementation on Fasting Triglycerides During Lifestyle Intervention in Adults With Mild-to-moderate Hypertriglyceridemia

Effect of Omega-3 Supplementation on Fasting Triglycerides During Lifestyle Intervention in Adults With Mild-to-moderate Hypertriglyceridemia: a Randomized Controlled Trial

Patients with hyperlipidemia will be allocated to the intervention or control group randomly. Participants of the intervention group will be provided with Omega-3 PUFA, while participants of the control group will be provided with a placebo which looked same as the drug in the intervention group. During the study, all participants can have nutritional counseling and education for a healthy diet, such as energy restriction when appropriate, reduced saturated fat and refined carbohydrate intake, increased vegetables, whole grains, and dietary fiber, and avoidance of excessive alcohol intake. The lipids, inflammatory factors, weight, and body composition will be assessed and recorded before, at 6 weeks, and at 12 weeks of the study.

Study Overview

• Status: Completed
• Conditions: Hyperlipidemias
• Intervention / Treatment: Dietary supplement: Omega-3 PUFA supplementation; Other: placebo

Detailed Description

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

Participants of the intervention group will be provided with Omega-3 PUFA, while participants of the control group will be provided with a placebo. Participants in the omega-3 group took six fish-oil capsules daily. Each 600-mg fish-oil capsule contained 298 mg eicosapentaenoic acid (EPA) and 105 mg docosahexaenoic acid (DHA), providing 1.788 g/day EPA, 0.630 g/day DHA, and 2.418 g/day EPA plus DHA. The capsules were manufactured by Nuokang Biotechnology Co., Ltd. (China) and stored at room temperature. Participants in the placebo group received six visually identical corn oil capsules daily. Active and placebo capsules were identical in appearance, packaging, color, and labeling. During the study, all participants can have nutritional counseling and education for an energy-restricted and low-fat diet. The lipids, inflammatory factors, weight, and body composition will be assessed and recorded before, in the middle, and at the end of the study.

• Study Type: Interventional
• Enrollment (Actual): 127
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100730
      • Peking Union Medical College Hospita

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 the 2016 guidelines for the prevention and treatment of dyslipidemia in Chinese adults, it meets the clinical diagnostic criteria of mild-moderate hyperlipidemia: hypertriglyceridemia [TG 1.7-5.4mmol/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 the past 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: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: omega-3 arm; participants of this arm will be provided with omega-3 PUFA, which contains 1.788 g/day EPA and 0.630 g/day DHA per day.	Dietary supplement: Omega-3 PUFA supplementation; 1.788 g/day EPA and 0.630 g/day DHA per day.; Other Names: lifestyle management
Placebo Comparator: placebo arm; Participants of this arm will be provided with the same amount of corn oil as the placebo, which is identical in appearance, packaging, color, and labeling.	Other: placebo; the same amont of corn oil as placebo; Other Names: lifestyle management

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
percentage change of triglyceride	percentage change in fasting triglyceride from baseline to week 12	From enrollment to the end of treatment at 12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
body weight	weight in kilogram	3 months
insulin resistance	homeostatic model assessment of insulin resistance (HOMA-IR)	3 months
visceral fat area (VFA)	visceral fat area (VFA) in cm2	3 months
non-HDL-C	non-HDL-C in mmol/L	3 months
HDL-C	high-density lipoprotein cholesterol in mmol/L	3 months
longitudinal TG trajectory of triglycerides	longitudinal TG trajectory at weeks 6 and 12	6 weeks and 12 weeks of the study
low-density lipoprotein cholesterol (LDL-C),	changes in low-density lipoprotein cholesterol (LDL-C)	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): December 1, 2023
• Study Completion (Actual): December 1, 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): July 29, 2026
• Last Update Submitted That Met QC Criteria: July 28, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: Hyperlipidemias; omega-3 PUFA
• Additional Relevant MeSH Terms: Metabolic Diseases; Dyslipidemias; Lipid Metabolism Disorders; Nutritional and Metabolic Diseases; Hyperlipidemias
• 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