Metabolic SyndromeNCT02137421
A Case Control Study of Resveratrol Effects in Coronary Artery Disease Patients With Metabolic Syndrome
A study testing Resveratrol (3, 4´, 5 trihydroxystilbene) in people with Metabolic Syndrome and Coronary Artery Disease, run by Tehran University of Medical Sciences at 1 site in Iran.
Trial summary
The aim of this study is to explore the role of Canonical β-catenin/Wnt and forkhead box O (FOXO) pathways by means of investigating their target genes in coronary artery disease (CAD) pathogenesis and to examine the effects of resveratrol (RES) on these pathways in CAD patients. Read more about this study
- Who is it for?
- Ages 40 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Metabolic Syndrome, Coronary Artery Disease
- What is being tested?
- Resveratrol (3, 4´, 5 trihydroxystilbene)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteIran
- Study dates
- Apr 2012to Dec 2014
- 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 40 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- -Three vessel coronary artery disease with metabolic syndrome based on WHO criteria
Who cannot join
- Malignancy,
- Myocardial infarction,
- Unstable angina,
- Previous coronary intervention,
- Inflammatory diseases,
- Diabetes,
Show all 11Show fewer
- Hypertension,
- Endocrine disorders,
- Other known chronic diseases,
- Antioxidant therapy or vitamin supplements in the previous 12 months,
- Smokers .
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Resveratrol on Crosstalk Between Canonical β-catenin/Wnt and FOXO Pathways in Coronary Artery Disease Patients With Metabolic Syndrome: A Case Control Study
The aim of this study is to explore the role of Canonical β-catenin/Wnt and forkhead box O (FOXO) pathways by means of investigating their target genes in coronary artery disease (CAD) pathogenesis and to examine the effects of resveratrol (RES) on these pathways in CAD patients.
Read the detailed description
Metabolic syndrome is a constellation of cardiovascular and metabolic risk factors including obesity, insulin resistance, hypertension and dyslipidemia. Coronary artery disease (CAD) is considerably linked with these risk factors. Oxidative stress has a major role in development of atherosclerosis that is believed as the most common pathologic process underlying CAD. The up-regulated gene-expression of free radical scavenging enzymes such as manganese superoxide dismutase (MnSOD) by members of the forkhead box O (FOXO) transcription factors is considered to be one of the paramount cell defensive mechanisms against oxidative damage. It is now well recognized that β-catenin binds to FOXOs during oxidative stress and acts as the pivotal mediator in canonical Wnt signaling, so that it translocates to the nucleus and interacts with the family of transcription factors T-cell factor/lymphoid enhancer factor (TCF/LEF), to regulate the expression of Wnt target genes. Recent evidence suggested that the canonical Wnt signaling plays a profound role in regulation of lipid metabolism and glucose homeostasis. Peroxisome proliferator-activated receptor delta (PPAR-δ) is one of the Wnt target genes which is believed to be operative in cardiometabolic protection. Interestingly, it has been demonstrated that impaired Wnt signaling pathway is contributed to inflammation, foam cell formation, and endothelial dysfunction which are recognized as atherosclerosis pathogenic factors. Resveratrol (RES) (3, 4´, 5 trihydroxystilbene), a natural polyphenol with antioxidant effects can be found in red grapes and its processed drinks (e.g. red wine), peanuts, pomegranates and mulberries.Increasing body of evidence suggest a protective role for RES against CAD, however the underlying mechanisms still remain to be elucidated. We perform this study on 10 metabolic syndrome patients with three-vessel CAD and 10 sex-aged matched (men with 40-55 years old) healthy subjects as controls. The effects of RES on β-Catenin, manganese superoxide dismutase (MnSOD), and peroxisome proliferator-activated receptor delta (PPAR-δ) expression are evaluated in peripheral blood mononuclear cells (PBMCs) of participants.
- Conditions
- Metabolic Syndrome, Coronary Artery Disease
- Being tested
- Resveratrol (3, 4´, 5 trihydroxystilbene)
- Keywords
- Coronary artery disease, Metabolic syndrome, Resveratrol, β-catenin, Wnt signaling, FOXO, MnSOD
- Medical subject headings
- Metabolic Syndrome, Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resveratrol (3, 4´, 5 trihydroxystilbene)Dietary supplement
Resveratrol (RES) (3, 4´, 5 trihydroxystilbene)
| Study group | Role | What they receive |
|---|---|---|
| CAD, Metabolic syndrome . | Experimental | Arm1:coronary artery disease with metabolic syndrome . Intervention:Resveratrol (3, 4´, 5 trihydroxystilbene), 50 micromolar,12hour treatment .
Each experiment repeats three times . Receives: Dietary Supplement: Resveratrol (3, 4´, 5 trihydroxystilbene) |
| Healthy subjects . | Experimental | Arm2:healthy subjects Intervention:Resveratrol (3, 4´, 5 trihydroxystilbene), 50 micromolar,12hour treatment .
Each experiment repeats three times . Receives: Dietary Supplement: Resveratrol (3, 4´, 5 trihydroxystilbene) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relative gene expression by real-time PCR (polymerase chain reaction)
PBMCs (2×106/well) are seeded in 96-well plates and undergo overnight incubation in humidified atmosphere at 37° C temperature with 5% CO2(carbon dioxide), then the medium is removed by centrifugation at 300g for 15 min and replaced with a fresh medium containing 50 micromolar resveratrol (dissolved in DMSO (Dimethyl sulfoxide)) for 12 hours. Then, RNA extraction, cDNA(complementary DNA) synthesis and real-time PCR are performed for β-catenin, MnSOD, and PPAR-delta genes .
Measured: Change from baseline after 12-hour treatment with resveratrol
Secondary outcomes (2)
MnSOD enzyme activity assay .
Measured: Change from baseline after 12-hour treatment with resveratrol
Total β-catenin protein measurement
Measured: Change from baseline after 12-hour treatment with resveratrol
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2014 (estimated)
- Study startApr 2012
- Primary completionAug 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic SyndromeStudies 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 N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tehran University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Taghi Golmohammadi, PhD, Study chair, Tehran University of Medical SciencesArash Hosseinnejad, MD-PhD, Study chair, Tehran University of Medical SciencesReza Meshkani, PhD, Study director, Tehran University of Medical SciencesMahmoud Shirzad, MD, Study director, Tehran Heart Center,Tehran University of Medical SciencesMehrnoosh Shanaki Bavarsad, PhD student, Principal investigator, Tehran University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02137421
- Sponsor's protocol ID
- 17001-30-01-91
- Status last verified
- May 2014
- First submitted
- 9 May 2014
- Last updated
- 2 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Resveratrol on Crosstalk Between Canonical β-catenin/Wnt and FOXO Pathways in Coronary Artery Disease Patients With Metabolic Syndrome: A Case Control Study
- ClinicalTrials.gov ID
- NCT02137421
- Acronym / sponsor ID
- 17001-30-01-91
- Conditions
- Metabolic Syndrome, Coronary Artery Disease
- Keywords
- Coronary artery disease, Metabolic syndrome, Resveratrol, β-catenin, Wnt signaling, FOXO, MnSOD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Tehran University of Medical SciencesUniversity, hospital or other
- Study start
- Apr 2012
- Primary completion
- Aug 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 13 May 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 to explore the role of Canonical β-catenin/Wnt and forkhead box O (FOXO) pathways by means of investigating their target genes in coronary artery disease (CAD) pathogenesis and to examine the effects of resveratrol (RES) on these pathways in CAD patients.
Detailed description
Metabolic syndrome is a constellation of cardiovascular and metabolic risk factors including obesity, insulin resistance, hypertension and dyslipidemia. Coronary artery disease (CAD) is considerably linked with these risk factors. Oxidative stress has a major role in development of atherosclerosis that is believed as the most common pathologic process underlying CAD. The up-regulated gene-expression of free radical scavenging enzymes such as manganese superoxide dismutase (MnSOD) by members of the forkhead box O (FOXO) transcription factors is considered to be one of the paramount cell defensive mechanisms against oxidative damage. It is now well recognized that β-catenin binds to FOXOs during oxidative stress and acts as the pivotal mediator in canonical Wnt signaling, so that it translocates to the nucleus and interacts with the family of transcription factors T-cell factor/lymphoid enhancer factor (TCF/LEF), to regulate the expression of Wnt target genes. Recent evidence suggested that the canonical Wnt signaling plays a profound role in regulation of lipid metabolism and glucose homeostasis. Peroxisome proliferator-activated receptor delta (PPAR-δ) is one of the Wnt target genes which is believed to be operative in cardiometabolic protection. Interestingly, it has been demonstrated that impaired Wnt signaling pathway is contributed to inflammation, foam cell formation, and endothelial dysfunction which are recognized as atherosclerosis pathogenic factors. Resveratrol (RES) (3, 4´, 5 trihydroxystilbene), a natural polyphenol with antioxidant effects can be found in red grapes and its processed drinks (e.g. red wine), peanuts, pomegranates and mulberries.Increasing body of evidence suggest a protective role for RES against CAD, however the underlying mechanisms still remain to be elucidated. We perform this study on 10 metabolic syndrome patients with three-vessel CAD and 10 sex-aged matched (men with 40-55 years old) healthy subjects as controls. The effects of RES on β-Catenin, manganese superoxide dismutase (MnSOD), and peroxisome proliferator-activated receptor delta (PPAR-δ) expression are evaluated in peripheral blood mononuclear cells (PBMCs) of participants.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CAD, Metabolic syndrome . | Experimental | Dietary Supplement: Resveratrol (3, 4´, 5 trihydroxystilbene)Arm1:coronary artery disease with metabolic syndrome . Intervention:Resveratrol (3, 4´, 5 trihydroxystilbene), 50 micromolar,12hour treatment . Each experiment repeats three times . |
| Healthy subjects . | Experimental | Dietary Supplement: Resveratrol (3, 4´, 5 trihydroxystilbene)Arm2:healthy subjects Intervention:Resveratrol (3, 4´, 5 trihydroxystilbene), 50 micromolar,12hour treatment . Each experiment repeats three times . |
Who may qualify
- Ages
- 40 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- -Three vessel coronary artery disease with metabolic syndrome based on WHO criteria
Key exclusion criteria (11 listed)
- Malignancy,
- Myocardial infarction,
- Unstable angina,
- Previous coronary intervention,
- Inflammatory diseases,
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 |
|---|---|---|
| Resveratrol (3, 4´, 5 trihydroxystilbene)Resveratrol (RES) (3, 4´, 5 trihydroxystilbene) | Dietary supplement | CAD, Metabolic syndrome ., Healthy subjects . |
Primary outcome
Relative gene expression by real-time PCR (polymerase chain reaction)
Time frame: Change from baseline after 12-hour treatment with resveratrol
PBMCs (2×106/well) are seeded in 96-well plates and undergo overnight incubation in humidified atmosphere at 37° C temperature with 5% CO2(carbon dioxide), then the medium is removed by centrifugation at 300g for 15 min and replaced with a fresh medium containing 50 micromolar resveratrol (dissolved in DMSO (Dimethyl sulfoxide)) for 12 hours. Then, RNA extraction, cDNA(complementary DNA) synthesis and real-time PCR are performed for β-catenin, MnSOD, and PPAR-delta genes .
2 secondary outcomes
MnSOD enzyme activity assay .
Time frame: Change from baseline after 12-hour treatment with resveratrol
Total β-catenin protein measurement
Time frame: Change from baseline after 12-hour treatment with resveratrol
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 2 May 2017.
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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.
Taghi Golmohammadi, PhD study chair
Tehran University of Medical Sciences
Arash Hosseinnejad, MD-PhD study chair
Tehran University of Medical Sciences
Reza Meshkani, PhD study director
Tehran University of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Resveratrol (3, 4´, 5 trihydroxystilbene) in people with Metabolic Syndrome and Coronary Artery 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 11 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 2 May 2017. 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. 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?
Relative gene expression by real-time PCR (polymerase chain reaction) (time frame: Change from baseline after 12-hour treatment with resveratrol). 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 2 May 2017.