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

NCT05015348 | Recruiting

• 1 other identifier: HS-2908
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Hyperlipidemias

Outcome Measures

Primary Outcomes (8)

• 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 Outcomes (2)

• adiponectin

  3 months

• leptin

  3 months

Study Arms (2)

O3A arm

EXPERIMENTAL

participants of this arm will be provided with omega-3 PUFA

Other: fish oil with omega-3 PUFA

placebo arm

PLACEBO COMPARATOR

participants of this arm will be provided with same amount of corn oil as placebo

Other: placebo

Interventions

fish oil with omega-3 PUFA OTHER

3.6g per day fish oil with omega-3 PUFA (EPA+DHA)

O3A arm

placebo OTHER

palm oil as placebo

placebo arm

Eligibility Criteria

• Age: 18 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 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.

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 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.

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

Study Sites (1)

Peking Union Medical College Hospita

Beijing, Beijing Municipality, 100730, China

RECRUITING

MeSH Terms

Conditions

Hyperlipidemias

Interventions

Fish Oils; Docosahexaenoic Acids

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Oils; Lipids; Fatty Acids, Omega-3; Dietary Fats, Unsaturated; Dietary Fats; Fats; Fatty Acids, Unsaturated; Fatty Acids

Study Officials

• Kang Yu, master

  Peking Union Medical College Hospital

  STUDY DIRECTOR

Central Study Contacts

Kang Yu, master

CONTACT

+8613801130457; yuk1997@sina.com

Fang Wang, master

CONTACT

+8615201646084; yours.fang@Hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, 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: March 1, 2024
• Study Completion: December 31, 2024
• Last Updated: January 1, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)