Back to resultsEffects of Omega-3 PUFA on Lipids, Inflammatory Factors and Body Composition in Patients With Hyperlipidemia
Primary Purpose
Hyperlipidemias
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
fish oil with omega-3 PUFA
placebo
Sponsored by
About this trial
This is an interventional treatment trial for Hyperlipidemias
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
O3A arm
placebo arm
Arm Description
participants of this arm will be provided with omega-3 PUFA
participants of this arm will be provided with same amount of palm oil as placebo
Outcomes
Primary Outcome Measures
triglyceride
triglyceride in mmol/L
cholesterol
cholesterol in mmol/L
LDL-C
LDL-C in mmol/L
TNF-α
TNF-α in ng/ml
NF-κB
NF-κB in ng/ml
hsCRP
hsCRP in mmol/L
interlukin-6
IL-6 in ng/ml
body weight
weight in kilogram
BMI
BMI in kg/m2
Secondary Outcome Measures
adiponectin
adiponectin in μg/mL
leptin
leptin in μg/mL
Full Information
NCT ID
NCT05015348
First Posted
July 24, 2021
Last Updated
August 15, 2021
Sponsor
Peking Union Medical College Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05015348
Brief Title
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
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Unknown status
Study Start Date
September 1, 2021 (Anticipated)
Primary Completion Date
December 1, 2021 (Anticipated)
Study Completion Date
January 31, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Peking Union Medical College Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperlipidemias
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
O3A arm
Arm Type
Experimental
Arm Description
participants of this arm will be provided with omega-3 PUFA
Arm Title
placebo arm
Arm Type
Placebo Comparator
Arm Description
participants of this arm will be provided with same amount of palm oil as placebo
Intervention Type
Other
Intervention Name(s)
fish oil with omega-3 PUFA
Intervention Description
3.6g per day fish oil with omega-3 PUFA (EPA+DHA)
Intervention Type
Other
Intervention Name(s)
placebo
Intervention Description
palm oil as placebo
Primary Outcome Measure Information:
Title
triglyceride
Description
triglyceride in mmol/L
Time Frame
3 months
Title
cholesterol
Description
cholesterol in mmol/L
Time Frame
3 months
Title
LDL-C
Description
LDL-C in mmol/L
Time Frame
3 months
Title
TNF-α
Description
TNF-α in ng/ml
Time Frame
3 months
Title
NF-κB
Description
NF-κB in ng/ml
Time Frame
3 months
Title
hsCRP
Description
hsCRP in mmol/L
Time Frame
3 months
Title
interlukin-6
Description
IL-6 in ng/ml
Time Frame
3 months
Title
body weight
Description
weight in kilogram
Time Frame
3 months
Title
BMI
Description
BMI in kg/m2
Time Frame
3 months
Secondary Outcome Measure Information:
Title
adiponectin
Description
adiponectin in μg/mL
Time Frame
3 months
Title
leptin
Description
leptin in μg/mL
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kang Yu, master
Phone
+8613801130457
Email
yuk1997@sina.com
First Name & Middle Initial & Last Name or Official Title & Degree
Fang Wang, master
Phone
+8615201646084
Email
yours.fang@Hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kang Yu, master
Organizational Affiliation
Peking Union Medical College Hospital
Official's Role
Study Director
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effects of Omega-3 PUFA on Lipids, Inflammatory Factors and Body Composition in Patients With Hyperlipidemia
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