Cardiovascular DiseasePhase 4NCT02117960
Assessing the Effects of Omega-3 Supplementation on Serum HSP27, HSP70, YKL40, BMP-4 Levels in Male Patient With CAD
A Phase 4 study testing Omega-3 in people with Cardiovascular Disease, run by Tehran University of Medical Sciences at 1 site in Iran.
Trial summary
The aim of this study is the comparison between the effects of supplementation with omega 3 or placebo for 8 weeks in serum level of BMP-4, YKL40, HSP70, HSP27 in patients with cardiovascular disease. Read more about this study
- Who is it for?
- Ages 45 to 65 years, men only
- Conditions the study is for
- Cardiovascular Disease
- What is being tested?
- Omega-3
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 21 participants
- Where
- 1 siteIran
- Study dates
- Dec 2011to Oct 2013
- Phase
- Phase 4
- 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 45 to 65 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- CVD patients 45- 65 years old, patients with ≥ 50% stenosis in at least one coronary angiogram demonstrated, body mass index in the range 18.5- 35, avoidance of dietary supplements, vitamins and herbal products at least 3 months before and throughout the intervention, willingness to participation,
Who cannot join
- people who have used omega 3 supplements in last 3 months, having chronic renal disease , GI disease, hepatobiliary diseases, hematological disorders, hypo- or hyperthyroidism, Smokers
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessing the Effects of Omega-3 Supplementation on Serum HSP27, HSP70, YKL40, BMP-4 Levels in Male Patient With Coronary Artery Disease
The aim of this study is the comparison between the effects of supplementation with omega 3 or placebo for 8 weeks in serum level of BMP-4, YKL40, HSP70, HSP27 in patients with cardiovascular disease.
Read the detailed description
The aim of this study is the comparison between the effects of supplementation with omega 3 or placebo for 8 weeks in serum level of BMP-4, YKL40, HSP70, HSP27 in patients with cardiovascular disease. In this randomized, double-blind clinical trial, placebo-controlled, single-center, and phase two trials, 42men aged 45-65 years with Coronary Artery Disease are enrolled in the study from Tehran Heart Center. After signing informed consent all individuals complete a general information form , 24-hour food recall for 3 days will be taken from the participants at the beginning and the end of the study,. Selected samples are randomly classified into 2 blocks of groups receiving supplement and placebo. The supplement group, will receive 4 g/day omega 3 fatty acid for 8 weeks and the placebo group will also receive placebo (containing 4 g of edible paraffin) (similar in terms of color, shape and size). Patients are recommended to sustain their diets and medication dose (s) during the study and also advised to maintain a constant level of physical activity. Blood samples will be collected after 8-12 hours fasting and anthropometric variables, biochemical parameters and physical activity before and after the trial will be measured.
- Conditions
- Cardiovascular Disease
- Being tested
- Omega-3, Placebo
- Keywords
- atherosclerotic, BMP-4, YKL40, HSP70, HSP27
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Omega-3Dietary supplement
Also called n-3 fatty acids, n-3 PUFA
4 cap 1 g Omega-3 per day for 2 months
PlaceboDietary supplement
4 cap 1 g Placebo(paraffin) per day for 2 months
| Study group | Role | What they receive |
|---|---|---|
| CVD, Omega-3 | Active comparator | patients with Cardiovascular disease who receive 4g/d omega-3 Receives: Dietary Supplement: Omega-3 |
| CVD, Placebo | Placebo comparator | patients with cardiovascular disease who receive 4 cap of placebo/day Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum Heat Shock Protein 70(HSP70)
Measured: Change frome baseline at 2 months
Secondary outcomes (5)
Serum Ox-LDL
Measured: Change frome baseline at 2 months
Serum BMP4 (Bone Morphogenic Protein4)
Measured: Change frome baseline at 2 months
Serum Heat Shock Protein 27(HSP27)
Measured: Change frome baseline at 2 months
Serum YKL40
Measured: Change frome baseline at 2 months
Serum hsCRP
Measured: Change frome baseline at 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2014 (estimated)
- Study startDec 2011
- Primary completionAug 2013
- Study completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseaseStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tehran University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mahmoud Jalali, Ph.D, Study director, Department of Nutrition & Biochemistry, School of Public Health, Tehran University of Medical Sciences (TUMS)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02117960
- Sponsor's protocol ID
- 2486
- Status last verified
- Apr 2015
- First submitted
- 16 Apr 2014
- Last updated
- 8 Apr 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Effects of Omega-3 Supplementation on Serum HSP27, HSP70, YKL40, BMP-4 Levels in Male Patient With Coronary Artery Disease
- ClinicalTrials.gov ID
- NCT02117960
- Acronym / sponsor ID
- 2486
- Conditions
- Cardiovascular Disease
- Keywords
- atherosclerotic, BMP-4, YKL40, HSP70, HSP27
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Tehran University of Medical SciencesUniversity, hospital or other
- Study start
- Dec 2011
- Primary completion
- Aug 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 21 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 aim of this study is the comparison between the effects of supplementation with omega 3 or placebo for 8 weeks in serum level of BMP-4, YKL40, HSP70, HSP27 in patients with cardiovascular disease.
Detailed description
The aim of this study is the comparison between the effects of supplementation with omega 3 or placebo for 8 weeks in serum level of BMP-4, YKL40, HSP70, HSP27 in patients with cardiovascular disease. In this randomized, double-blind clinical trial, placebo-controlled, single-center, and phase two trials, 42men aged 45-65 years with Coronary Artery Disease are enrolled in the study from Tehran Heart Center. After signing informed consent all individuals complete a general information form , 24-hour food recall for 3 days will be taken from the participants at the beginning and the end of the study,. Selected samples are randomly classified into 2 blocks of groups receiving supplement and placebo. The supplement group, will receive 4 g/day omega 3 fatty acid for 8 weeks and the placebo group will also receive placebo (containing 4 g of edible paraffin) (similar in terms of color, shape and size). Patients are recommended to sustain their diets and medication dose (s) during the study and also advised to maintain a constant level of physical activity. Blood samples will be collected after 8-12 hours fasting and anthropometric variables, biochemical parameters and physical activity before and after the trial will be measured.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CVD, Omega-3 | Active comparator | Dietary Supplement: Omega-3patients with Cardiovascular disease who receive 4g/d omega-3 |
| CVD, Placebo | Placebo comparator | Dietary Supplement: Placebopatients with cardiovascular disease who receive 4 cap of placebo/day |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- CVD patients 45- 65 years old, patients with ≥ 50% stenosis in at least one coronary angiogram demonstrated, body mass index in the range 18.5- 35, avoidance of dietary supplements, vitamins and herbal products at least 3 months before and throughout the intervention, willingness to participation,
Key exclusion criteria (1 listed)
- people who have used omega 3 supplements in last 3 months, having chronic renal disease , GI disease, hepatobiliary diseases, hematological disorders, hypo- or hyperthyroidism, Smokers
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-3Also: n-3 fatty acids, n-3 PUFA4 cap 1 g Omega-3 per day for 2 months | Dietary supplement | CVD, Omega-3 |
| Placebo4 cap 1 g Placebo(paraffin) per day for 2 months | Dietary supplement | CVD, Placebo |
Primary outcome
Serum Heat Shock Protein 70(HSP70)
Time frame: Change frome baseline at 2 months
5 secondary outcomes
Serum Ox-LDL
Time frame: Change frome baseline at 2 months
Serum BMP4 (Bone Morphogenic Protein4)
Time frame: Change frome baseline at 2 months
Serum Heat Shock Protein 27(HSP27)
Time frame: Change frome baseline at 2 months
Serum YKL40
Time frame: Change frome baseline at 2 months
Serum hsCRP
Time frame: Change frome baseline at 2 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 8 Apr 2015.
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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.
Mahmoud Jalali, Ph.D study director
Department of Nutrition & Biochemistry, School of Public Health, Tehran University of Medical Sciences (TUMS)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Omega-3 in people with Cardiovascular Disease, run by Tehran University of Medical Sciences at 1 site in Iran.
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 1 inclusion and 1 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 8 Apr 2015. 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 Iran. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Serum Heat Shock Protein 70(HSP70) (time frame: Change frome baseline at 2 months). 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 8 Apr 2015.