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Vascular Effects of Hesperidin in Metabolic Syndrome

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ClinicalTrials.gov Identifier: NCT00914251
Recruitment Status : Unknown
Verified June 2009 by University of Rome Tor Vergata.
Recruitment status was:  Recruiting
First Posted : June 4, 2009
Last Update Posted : June 17, 2009
Sponsor:
Information provided by:
University of Rome Tor Vergata

Tracking Information
First Submitted Date  ICMJE June 3, 2009
First Posted Date  ICMJE June 4, 2009
Last Update Posted Date June 17, 2009
Study Start Date  ICMJE November 2008
Actual Primary Completion Date March 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 3, 2009)
Safety of oral supplementation of hesperidin [ Time Frame: 3 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 3, 2009)
Endothelial function assessed by FMD %. Inflammatory status assessed by biochemical markers. [ Time Frame: 3 weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Vascular Effects of Hesperidin in Metabolic Syndrome
Official Title  ICMJE Positive Vascular Effect of Hesperidin in Subjects Affected by Metabolic Syndrome
Brief Summary It has been suggested that cardiovascular risk factors either independently or in cluster (metabolic syndrome) increase the risk of both type 2 diabetes (DM2) and cardiovascular diseases (CVD). Consumption of citrus fruits is linked to reduced cardiovascular morbidity and mortality. Hesperidin is a flavanone abundant in citrus fruit with putative vasodilator actions in vitro. While molecular mechanisms of vascular actions of hesperidin begin to be explored, no data on in vivo vascular effect of this flavanone has been ever acquired.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE
  • Endothelial Dysfunction
  • Metabolic Syndrome
Intervention  ICMJE
  • Drug: Hesperidin
    Administration of oral Hesperidin, 500 mg/daily
  • Drug: Placebo
    Administration of oral Placebo, 500 mg/daily
Study Arms  ICMJE
  • Active Comparator: Hesperidin, 500 mg per day
    500 mg daily of oral Hesperidin for 3 weeks
    Intervention: Drug: Hesperidin
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: June 3, 2009)
30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2010
Actual Primary Completion Date March 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Metabolic Syndrome (ATPIII criteria)
  • BMI <35
  • Age 20-55

Exclusion Criteria:

  • History of cancer.
  • History of cardiovascular diseases.
  • Any other acute or chronic illness which requires administration of steroids or other drugs able to interfere with glucose or lipid metabolism.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Italy
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00914251
Other Study ID Numbers  ICMJE 073/09
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Stefano Rizza, Medicine Internal Department
Study Sponsor  ICMJE University of Rome Tor Vergata
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account University of Rome Tor Vergata
Verification Date June 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP