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Vascular Effects of Hesperidin in Metabolic Syndrome

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2009 by University of Rome Tor Vergata.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University of Rome Tor Vergata
ClinicalTrials.gov Identifier:
NCT00914251
First received: June 3, 2009
Last updated: June 16, 2009
Last verified: June 2009
History of Changes
  Purpose

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 Intervention Phase
Endothelial Dysfunction
Metabolic Syndrome
 Drug: Hesperidin
Drug: Placebo
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Positive Vascular Effect of Hesperidin in Subjects Affected by Metabolic Syndrome

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Rome Tor Vergata:

Primary Outcome Measures:
  • Safety of oral supplementation of hesperidin [ Time Frame: 3 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Endothelial function assessed by FMD %. Inflammatory status assessed by biochemical markers. [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: November 2008
Estimated Study Completion Date: December 2010
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   20 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00914251

Locations
Italy
University of Rome Tor Vergata Recruiting
Rome, Italy, 00133
Contact: Stefano Rizza, MD         rizza@med.uniroma2.it    
Principal Investigator: Stefano Rizza, MD            
Sub-Investigator: Manfredi Tesauro, MD            
Sub-Investigator: Davide Lauro, MD            
Sponsors and Collaborators
University of Rome Tor Vergata
  More Information

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Stefano Rizza, Medicine Internal Department
ClinicalTrials.gov Identifier: NCT00914251     History of Changes
Other Study ID Numbers: 073/09
Study First Received: June 3, 2009
Last Updated: June 16, 2009
Health Authority: Italy: Ethics Committee

Keywords provided by University of Rome Tor Vergata:
endothelial
metabolic syndrome
hesperidin

Additional relevant MeSH terms:
Metabolic Syndrome X
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on June 17, 2013