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

Hyperlipidemias Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05015348
• Other study ID #: HS-2908
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 1, 2021
• Est. completion date: January 31, 2022

Study information

• Verified date: August 2021
• Source: Peking Union Medical College Hospital
• Contact: Kang Yu, master
• Phone: +8613801130457
• Email: yuk1997[@]sina.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 120
• Est. completion date: January 31, 2022
• Est. primary completion date: December 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 ß 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.

Related Conditions & MeSH terms

• Hyperlipidemias
• Hyperlipoproteinemias

Intervention

Other:
• fish oil with omega-3 PUFA
3.6g per day fish oil with omega-3 PUFA (EPA+DHA)
• placebo
palm oil as placebo

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	triglyceride	triglyceride in mmol/L	3 months
Primary	cholesterol	cholesterol in mmol/L	3 months
Primary	LDL-C	LDL-C in mmol/L	3 months
Primary	TNF-a	TNF-a in ng/ml	3 months
Primary	NF-?B	NF-?B in ng/ml	3 months
Primary	hsCRP	hsCRP in mmol/L	3 months
Primary	interlukin-6	IL-6 in ng/ml	3 months
Primary	body weight	weight in kilogram	3 months
Primary	BMI	BMI in kg/m2	3 months
Secondary	adiponectin	adiponectin in µg/mL	3 months
Secondary	leptin	leptin in µg/mL	3 months