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Vascular Effects of Hesperidin in Metabolic Syndrome

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified June 2009 by University of Rome Tor Vergata.
Recruitment status was:  Recruiting
ClinicalTrials.gov Identifier:
First Posted: June 4, 2009
Last Update Posted: June 17, 2009
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.
Information provided by:
University of Rome Tor Vergata
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
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Positive Vascular Effect of Hesperidin in Subjects Affected by Metabolic Syndrome

Resource links provided by NLM:

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

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

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

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


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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.
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00914251

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 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
First Submitted: June 3, 2009
First Posted: June 4, 2009
Last Update Posted: June 17, 2009
Last Verified: June 2009

Keywords provided by University of Rome Tor Vergata:
metabolic syndrome

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