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

NCT05015348 | Completed DMC

• 1 other identifier: HS-2908
• Study Type: interventional
• Target: 127
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hyperlipidemias

Keywords

Hyperlipidemias; omega-3 PUFA

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• insulin resistance

  3 months

• visceral fat area (VFA)

  3 months

• body weight

  3 months

• non-HDL-C

  3 months

• HDL-C

  3 months

Study Arms (2)

omega-3 arm

EXPERIMENTAL

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

placebo arm

PLACEBO COMPARATOR

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

Interventions

placebo OTHER

the same amont of corn oil as placebo

Also known as: lifestyle management

placebo arm

Omega-3 PUFA supplementation DIETARY_SUPPLEMENT

1.788 g/day EPA and 0.630 g/day DHA per day.

Also known as: lifestyle management

omega-3 arm

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \[1\] 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.

You may not qualify if:

• \[1\] 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.

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

Study Sites (1)

Peking Union Medical College Hospita

Beijing, Beijing Municipality, 100730, China

Location

MeSH Terms

Conditions

Hyperlipidemias

Condition Hierarchy (Ancestors)

Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Kang Yu, master

  Peking Union Medical College Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 24, 2021
• First Posted: August 20, 2021
• Study Start: December 1, 2021
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2024
• Last Updated: July 29, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)