NCT02137421

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2012

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2012

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

May 9, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 13, 2014

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

May 2, 2017

Status Verified

May 1, 2014

Enrollment Period

2.3 years

First QC Date

May 9, 2014

Last Update Submit

April 30, 2017

Conditions

Metabolic SyndromeCoronary Artery Disease

Keywords

Coronary artery diseaseMetabolic syndromeResveratrolβ-cateninWnt signalingFOXOMnSOD

Outcome Measures

Primary Outcomes (1)

  • 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 .

    Change from baseline after 12-hour treatment with resveratrol

Secondary Outcomes (2)

  • MnSOD enzyme activity assay .

    Change from baseline after 12-hour treatment with resveratrol

  • Total β-catenin protein measurement

    Change from baseline after 12-hour treatment with resveratrol

Other Outcomes (1)

  • PBMCs viability assay by MTT ( 3-(4,5-dimethylthiazol-2-yl)-2,5-diphenyltetrazolium bromide ) test .

    Change from baseline after 12 and 24-hour treatment with resveratrol

Study Arms (2)

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 .

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 .

Dietary Supplement: Resveratrol (3, 4´, 5 trihydroxystilbene)

Interventions

Resveratrol (3, 4´, 5 trihydroxystilbene)DIETARY_SUPPLEMENT

Resveratrol (RES) (3, 4´, 5 trihydroxystilbene)

CAD, Metabolic syndrome .Healthy subjects .

Eligibility Criteria

Age40 Years - 55 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Three vessel coronary artery disease with metabolic syndrome based on WHO criteria

You may not qualify if:

  • Malignancy,
  • Myocardial infarction,
  • Unstable angina,
  • Previous coronary intervention,
  • Inflammatory diseases,
  • Diabetes,
  • Hypertension,
  • Endocrine disorders,
  • Other known chronic diseases,
  • Antioxidant therapy or vitamin supplements in the previous 12 months,
  • Smokers .

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Islamic Republic of Iran

Tehran, Iran

Location

MeSH Terms

Conditions

Metabolic SyndromeCoronary Artery Disease

Interventions

Resveratrol

Condition Hierarchy (Ancestors)

Insulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesCoronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

StilbestrolsStilbenesBenzylidene CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolyphenolsPhenols

Study Officials

  • Taghi Golmohammadi, PhD

    Tehran University of Medical Sciences

    STUDY CHAIR

  • Arash Hosseinnejad, MD-PhD

    Tehran University of Medical Sciences

    STUDY CHAIR

  • Reza Meshkani, PhD

    Tehran University of Medical Sciences

    STUDY DIRECTOR

  • Mahmoud Shirzad, MD

    Tehran Heart Center,Tehran University of Medical Sciences

    STUDY DIRECTOR

  • Mehrnoosh Shanaki Bavarsad, PhD student

    Tehran University of Medical Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 9, 2014

First Posted

May 13, 2014

Study Start

April 1, 2012

Primary Completion

August 1, 2014

Study Completion

December 1, 2014

Last Updated

May 2, 2017

Record last verified: 2014-05

Locations

IR(1)