HyperlipidemiasNCT05015348
Effect of Omega-3 Supplementation on Fasting Triglycerides During Lifestyle Intervention in Adults With Mild-to-moderate Hypertriglyceridemia
A study testing Omega-3 PUFA supplementation in people with Hyperlipidemias, run by Peking Union Medical College Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 79 years
- Conditions the study is for
- Hyperlipidemias
- What is being tested?
- Omega-3 PUFA supplementation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 127 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2021to 1 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- [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.
Who cannot join
- [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.
Trial locations and contacts
1 site in 1 country.
China1 site
Peking Union Medical College Hospita
Beijing, Beijing Municipality, 100730
About this study
Official title: Effect of Omega-3 Supplementation on Fasting Triglycerides During Lifestyle Intervention in Adults With Mild-to-moderate Hypertriglyceridemia: a Randomized Controlled Trial
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.
Read the detailed description
Randomization tables were generated by the statistician and provided to the investigational pharmacist who distributed the blinded capsules to participants.
Participants of the intervention group will be provided with Omega-3 PUFA, while participants of the control group will be provided with a placebo. Participants in the omega-3 group took six fish-oil capsules daily. Each 600-mg fish-oil capsule contained 298 mg eicosapentaenoic acid (EPA) and 105 mg docosahexaenoic acid (DHA), providing 1.788 g/day EPA, 0.630 g/day DHA, and 2.418 g/day EPA plus DHA. The capsules were manufactured by Nuokang Biotechnology Co., Ltd. (China) and stored at room temperature. Participants in the placebo group received six visually identical corn oil capsules daily. Active and placebo capsules were identical in appearance, packaging, color, and labeling. During the study, all participants can have nutritional counseling and education for an energy-restricted and low-fat diet. The lipids, inflammatory factors, weight, and body composition will be assessed and recorded before, in the middle, and at the end of the study.
- Conditions
- Hyperlipidemias
- Being tested
- Omega-3 PUFA supplementation, placebo
- Keywords
- Hyperlipidemias, omega-3 PUFA
- Medical subject headings
- Hyperlipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Omega-3 PUFA supplementationDietary supplement
Also called lifestyle management
1.788 g/day EPA and 0.630 g/day DHA per day.
placeboOther
Also called lifestyle management
the same amont of corn oil as placebo
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
percentage change of triglyceride
percentage change in fasting triglyceride from baseline to week 12
Measured: From enrollment to the end of treatment at 12 weeks
Secondary outcomes (7)
insulin resistance
homeostatic model assessment of insulin resistance (HOMA-IR)
Measured: 3 months
visceral fat area (VFA)
visceral fat area (VFA) in cm2
Measured: 3 months
body weight
weight in kilogram
Measured: 3 months
non-HDL-C
non-HDL-C in mmol/L
Measured: 3 months
HDL-C
high-density lipoprotein cholesterol in mmol/L
Measured: 3 months
longitudinal TG trajectory of triglycerides
longitudinal TG trajectory at weeks 6 and 12
Measured: 6 weeks and 12 weeks of the study
low-density lipoprotein cholesterol (LDL-C),
changes in low-density lipoprotein cholesterol (LDL-C)
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2021
- Study start1 Dec 2021
- Primary completion1 Dec 2023
- Study completion1 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperlipidemiasStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 127 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kang Yu, master, Study director, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05015348
- Sponsor's protocol ID
- HS-2908
- Status last verified
- Jul 2026
- First submitted
- 24 Jul 2021
- Last updated
- 29 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Omega-3 Supplementation on Fasting Triglycerides During Lifestyle Intervention in Adults With Mild-to-moderate Hypertriglyceridemia: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05015348
- Acronym / sponsor ID
- HS-2908
- Conditions
- Hyperlipidemias
- Keywords
- Hyperlipidemias, omega-3 PUFA
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 127 participants (actual)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 1 Dec 2023 (actual)
- Study completion
- 1 Dec 2024 (actual)
- First posted
- 20 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Randomization tables were generated by the statistician and provided to the investigational pharmacist who distributed the blinded capsules to participants.
Participants of the intervention group will be provided with Omega-3 PUFA, while participants of the control group will be provided with a placebo. Participants in the omega-3 group took six fish-oil capsules daily. Each 600-mg fish-oil capsule contained 298 mg eicosapentaenoic acid (EPA) and 105 mg docosahexaenoic acid (DHA), providing 1.788 g/day EPA, 0.630 g/day DHA, and 2.418 g/day EPA plus DHA. The capsules were manufactured by Nuokang Biotechnology Co., Ltd. (China) and stored at room temperature. Participants in the placebo group received six visually identical corn oil capsules daily. Active and placebo capsules were identical in appearance, packaging, color, and labeling. During the study, all participants can have nutritional counseling and education for an energy-restricted and low-fat diet. The lipids, inflammatory factors, weight, and body composition will be assessed and recorded before, in the middle, and at the end of the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| omega-3 arm | Experimental | Dietary Supplement: Omega-3 PUFA supplementationparticipants 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. |
| placebo arm | Placebo comparator | Other: placeboParticipants 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. |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- [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.
Key exclusion criteria (8 listed)
- [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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Omega-3 PUFA supplementationAlso: lifestyle management1.788 g/day EPA and 0.630 g/day DHA per day. | Dietary supplement | omega-3 arm |
| placeboAlso: lifestyle managementthe same amont of corn oil as placebo | Other | placebo arm |
Primary outcome
percentage change of triglyceride
Time frame: From enrollment to the end of treatment at 12 weeks
percentage change in fasting triglyceride from baseline to week 12
7 secondary outcomes
insulin resistance
Time frame: 3 months
visceral fat area (VFA)
Time frame: 3 months
body weight
Time frame: 3 months
non-HDL-C
Time frame: 3 months
HDL-C
Time frame: 3 months
longitudinal TG trajectory of triglycerides
Time frame: 6 weeks and 12 weeks of the study
low-density lipoprotein cholesterol (LDL-C),
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2026.
- Individual participant dataSharing planned: No
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A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kang Yu, master study director
Peking Union Medical College Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Omega-3 PUFA supplementation in people with Hyperlipidemias, run by Peking Union Medical College Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
percentage change of triglyceride (time frame: From enrollment to the end of treatment at 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2026.