Clinical trial NCT05015348: Effects of Omega-3 PUFA on Lipids, Inflammatory Factors and Body Composition in Patients with Hyperlipidemia
Official title: Effects of Omega-3 Polyenoic Acid on Blood Lipid, Inflammatory Factors and Body Composition in Patients with Hyperlipidemia
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hyperlipidemias
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2021-08-20
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: triglyceride
timeFrame: 3 months
measure: cholesterol
timeFrame: 3 months
measure: LDL-C
timeFrame: 3 months
measure: TNF-α
timeFrame: 3 months
measure: hsCRP
timeFrame: 3 months
measure: interlukin-6
timeFrame: 3 months
measure: body weight
timeFrame: 3 months
measure: BMI
timeFrame: 3 months
Secondary outcomes:
measure: adiponectin
timeFrame: 3 months
measure: leptin
timeFrame: 3 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospita
state: Beijing
Study officials:
affiliation: Peking Union Medical College Hospital
name: Kang Yu, master
role: STUDY_DIRECTOR
References: