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Vascular Effects of Hesperidin in Metabolic Syndrome

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. 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
Information provided by:
University of Rome Tor Vergata

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.

Condition or disease Intervention/treatment Phase
Endothelial Dysfunction Metabolic Syndrome Drug: Hesperidin Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Positive Vascular Effect of Hesperidin in Subjects Affected by Metabolic Syndrome
Study Start Date : November 2008
Actual Primary Completion Date : March 2009
Estimated Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: Hesperidin, 500 mg per day
500 mg daily of oral Hesperidin for 3 weeks
Drug: Hesperidin
Administration of oral Hesperidin, 500 mg/daily

Placebo Comparator: Placebo Drug: Placebo
Administration of oral Placebo, 500 mg/daily

Primary Outcome Measures :
  1. Safety of oral supplementation of hesperidin [ Time Frame: 3 weeks ]

Secondary Outcome Measures :
  1. Endothelial function assessed by FMD %. Inflammatory status assessed by biochemical markers. [ Time Frame: 3 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00914251

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University of Rome Tor Vergata Recruiting
Rome, Italy, 00133
Contact: Stefano Rizza, MD   
Principal Investigator: Stefano Rizza, MD         
Sub-Investigator: Manfredi Tesauro, MD         
Sub-Investigator: Davide Lauro, MD         
Sponsors and Collaborators
University of Rome Tor Vergata
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Stefano Rizza, Medicine Internal Department Identifier: NCT00914251    
Other Study ID Numbers: 073/09
First Posted: June 4, 2009    Key Record Dates
Last Update Posted: June 17, 2009
Last Verified: June 2009
Keywords provided by University of Rome Tor Vergata:
metabolic syndrome
Additional relevant MeSH terms:
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Metabolic Syndrome
Pathologic Processes
Insulin Resistance
Glucose Metabolism Disorders
Metabolic Diseases