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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:

Study Description
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

Study Design

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
Primary Completion Date : March 2009
Estimated Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

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


Outcome Measures

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 ]

Eligibility Criteria

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
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

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


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:
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 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:
endothelial
metabolic syndrome
hesperidin

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