Suboptimal Health StatusPhase 3NCT02103517
Fish Oil and Cardiovascular Suboptimal Health
A Phase 3 study testing Omega -3 fatty acids in people with Suboptimal Health Status, run by Chinese PLA General Hospital at 3 sites in China.
Trial summary
The purpose of this study is to determine whether omega-3 fatty acids supplementation are effective in the improvement of suboptimal health status and cardiovascular risk. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Suboptimal Health Status
- What is being tested?
- Omega -3 fatty acids
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 422 participants
- Where
- 3 sitesChina
- Study dates
- Sep 2014to Jul 2015
- Phase
- Phase 3
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- suboptimal health status, defined as the score of suboptimal health questionnaire ≥35.
- at least one of cardiovascular risk factors:
- overweight or obesity, defined as body mass index (BMI) ≥25 kg/m2.
- systolic blood pressure ≥130 and <140 mmHg and diastolic blood pressure <90 mmHg, or diastolic blood pressure ≥85 and <90 mmHg and systolic blood pressure <140 mmHg
- fasting plasma glucose ≥100 and <126 mg/dL
- total cholesterol ≥200 and <240 mg/dL, triglyceride ≥150 and <200 mg/dL, low density lipoprotein-cholesterol ≥130 and <160 mg/dL,and/or high density lipoprotein-cholesterol <40 mg/dL
- written informed consent
Who cannot join
- history of system diseases, such as cardiovascular diseases, digestive system diseases, diseases of respiratory system, blood and immune system diseases, nervous system diseases, endocrine system diseases, and diseases of the genitourinary system.
- history of mental illness.
- pregnant or breastfeeding.
- use of antihypertensive, antidiabetic, or lipid-lowering drugs within the past two weeks.
- use of fish oil capsules or other supplements containing omega-3 fatty acids within the past two weeks.
- allergy or intolerance to fish oil, corn oil, omega-3 fatty acids, or vitamin E.
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- participation in another trial.
- unable to promise to not use drugs and other fish oils during the study.
- unable to provide informed written consent.
Trial locations and contacts
3 sites in 1 country.
China3 sites
Chinese PLA General Hospital
Beijing, Beijing Municipality, 100853
Sichuan Province People's Hospital
Chengdu, Sichuan, 610000
First Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, 150001
About this study
Official title: Risk and Prevention Study: Optimisation of the Preventive Strategies and Evaluation of the Efficacy of n-3 Fatty Acids in Subjects at High Cardiovascular Risk and Suboptimal Health Status
The purpose of this study is to determine whether omega-3 fatty acids supplementation are effective in the improvement of suboptimal health status and cardiovascular risk.
Read the detailed description
The Suboptimal health status questionnaire (SHSQ-25) is used to evaluate the suboptimal health status. The SHSQ-25 includes 25 questions. The score of the SHSQ-25 is from 0 to 100. Suboptimal health status is defined as the SHSQ-25 score above than 35. The higher scores of the SHSQ-25 one gets, the more severity of suboptimal health status he/she has. All participants are asked to fill in the SHSQ-25 before and after the intervention. If the score decreases after the intervention, it means that the suboptimal health status has been improved.
- Conditions
- Suboptimal Health Status
- Being tested
- Omega -3 fatty acids, Placebo: Corn oil
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Omega -3 fatty acidsDietary supplement
Each subject assigned to active treatment group will receive 4 g/day capsule of omega-3 fatty acids.
Placebo: Corn oilDietary supplement
Each subject assigned to the control group will receive 4 g/day capsule of corn oil.
| Study group | Role | What they receive |
|---|---|---|
| Omega-3 fatty acid capsules | Experimental | Omega-3 fatty acid capsules, 4 g/day, requiring intake 2 capsules (1g each one) in the morning and two at night for 3 months. Receives: Dietary Supplement: Omega -3 fatty acids |
| corn oil | Placebo comparator | Corn oil in similar presentation as omega-3 fatty acid capsules, requiring intake 2 capsules in the morning and two at night for 3 months. Receives: Dietary Supplement: Placebo: Corn oil |
What is being measured
The primary outcome is the main question the study is designed to answer.
the improvement of suboptimal health status
The improvement of suboptimal health status is evaluated by the change of the SHSQ-25 scores after intervention.
Measured: three months
the improvement of traditional cardiovascular risk factors
To investigate the changes of traditional cardiovascular risk factors such as blood pressure, lipids, fasting plasma glucose, and body mass index with three months supplementation of omega-3 fatty acids. Abnormal cardiovascular risk factors are defined according to the Adult Treatment Panel III criteria for metabolic syndromes and the recommendation by the Working Group on Obesity in China. The number of abnormal cardiovascular risk factors for each participant is recorded before and after intervention. If the number decreases after intervention, it means that the traditional cardiovascular risk factors have been improved.
Measured: three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2014 (estimated)
- Study startSep 2014
- Primary completionJul 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Suboptimal Health StatusStudies of the same condition, open and under way.
- More trials run by Chinese PLA General 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 422 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese PLA General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Qiang Zeng, MD, Chinese PLA General Hospital
- Investigators
- Qiang Zeng, M.D, Principal investigator, Chinese PLA General HospitalSheng-Yong Dong, M.D, Principal investigator, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02103517
- Sponsor's protocol ID
- 2012BAI37B04
- Other IDs
- N3FACSH
- Status last verified
- Jan 2017
- First submitted
- 27 Mar 2014
- Last updated
- 4 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Zeng Q, Dong SY, Liu YP, Fu J, Shuai P, Zhao ZM, Li TX. Effects of fish oil-derived fatty acids on suboptimal cardiovascular health: A multicenter, randomized, double-blind, placebo-controlled trial. Nutr Metab Cardiovasc Dis. 2017 Nov;27(11):964-970. doi: 10.1016/j.numecd.2017.09.004. Epub 2017 Sep 21.
PubMed 29066159
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk and Prevention Study: Optimisation of the Preventive Strategies and Evaluation of the Efficacy of n-3 Fatty Acids in Subjects at High Cardiovascular Risk and Suboptimal Health Status
- ClinicalTrials.gov ID
- NCT02103517
- Acronym / sponsor ID
- 2012BAI37B04
- Conditions
- Suboptimal Health Status
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 422 participants (actual)
- Lead sponsor
- Chinese PLA General HospitalUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 4 Apr 2014 (estimated)
- 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.
The purpose of this study is to determine whether omega-3 fatty acids supplementation are effective in the improvement of suboptimal health status and cardiovascular risk.
Detailed description
The Suboptimal health status questionnaire (SHSQ-25) is used to evaluate the suboptimal health status. The SHSQ-25 includes 25 questions. The score of the SHSQ-25 is from 0 to 100. Suboptimal health status is defined as the SHSQ-25 score above than 35. The higher scores of the SHSQ-25 one gets, the more severity of suboptimal health status he/she has. All participants are asked to fill in the SHSQ-25 before and after the intervention. If the score decreases after the intervention, it means that the suboptimal health status has been improved.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Omega-3 fatty acid capsules | Experimental | Dietary Supplement: Omega -3 fatty acidsOmega-3 fatty acid capsules, 4 g/day, requiring intake 2 capsules (1g each one) in the morning and two at night for 3 months. |
| corn oil | Placebo comparator | Dietary Supplement: Placebo: Corn oilCorn oil in similar presentation as omega-3 fatty acid capsules, requiring intake 2 capsules in the morning and two at night for 3 months. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- suboptimal health status, defined as the score of suboptimal health questionnaire ≥35.
- at least one of cardiovascular risk factors:
- written informed consent
Key exclusion criteria (9 listed)
- history of system diseases, such as cardiovascular diseases, digestive system diseases, diseases of respiratory system, blood and immune system diseases, nervous system diseases, endocrine system diseases, and diseases of the genitourinary system.
- history of mental illness.
- pregnant or breastfeeding.
- use of antihypertensive, antidiabetic, or lipid-lowering drugs within the past two weeks.
- use of fish oil capsules or other supplements containing omega-3 fatty acids within the past two weeks.
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 fatty acidsEach subject assigned to active treatment group will receive 4 g/day capsule of omega-3 fatty acids. | Dietary supplement | Omega-3 fatty acid capsules |
| Placebo: Corn oilEach subject assigned to the control group will receive 4 g/day capsule of corn oil. | Dietary supplement | corn oil |
Primary outcome
the improvement of suboptimal health status
Time frame: three months
The improvement of suboptimal health status is evaluated by the change of the SHSQ-25 scores after intervention.
the improvement of traditional cardiovascular risk factors
Time frame: three months
To investigate the changes of traditional cardiovascular risk factors such as blood pressure, lipids, fasting plasma glucose, and body mass index with three months supplementation of omega-3 fatty acids. Abnormal cardiovascular risk factors are defined according to the Adult Treatment Panel III criteria for metabolic syndromes and the recommendation by the Working Group on Obesity in China. The number of abnormal cardiovascular risk factors for each participant is recorded before and after intervention. If the number decreases after intervention, it means that the traditional cardiovascular risk factors have been improved.
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 4 Jan 2017.
- Derived from this study: PubMed 29066159Zeng Q, Dong SY, Liu YP, Fu J, Shuai P, Zhao ZM, Li TX. Effects of fish oil-derived fatty acids on suboptimal cardiovascular health: A multicenter, randomized, double-blind, placebo-controlled trial. Nutr Metab Cardiovasc Dis. 2017 Nov;27(11):964-970. doi: 10.1016/j.numecd.2017.09.004. Epub 2017 Sep 21.
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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.
Qiang Zeng, M.D principal investigator
Chinese PLA General Hospital
Sheng-Yong Dong, M.D principal investigator
Chinese PLA General Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Omega -3 fatty acids in people with Suboptimal Health Status, run by Chinese PLA General Hospital at 3 sites 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 7 inclusion and 9 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 4 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
the improvement of suboptimal health status (time frame: three months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02103517, which also lists 1 linked publication.
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 4 Jan 2017.