Vascular Effects of Hesperidin in Metabolic Syndrome

June 16, 2009 updated by: University of Rome Tor Vergata

Positive Vascular Effect of Hesperidin in Subjects Affected by Metabolic Syndrome

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Rome, Italy, 00133
        • Recruiting
        • University of Rome Tor Vergata
        • Contact:
        • Principal Investigator:
          • Stefano Rizza, MD
        • Sub-Investigator:
          • Manfredi Tesauro, MD
        • Sub-Investigator:
          • Davide Lauro, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
Administration of oral Placebo, 500 mg/daily
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Safety of oral supplementation of hesperidin
Time Frame: 3 weeks
3 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Endothelial function assessed by FMD %. Inflammatory status assessed by biochemical markers.
Time Frame: 3 weeks
3 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Rome Tor Vergata

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2008

Primary Completion (Actual)

March 1, 2009

Study Completion (Anticipated)

December 1, 2010

Study Registration Dates

First Submitted

June 3, 2009

First Submitted That Met QC Criteria

June 3, 2009

First Posted (Estimate)

June 4, 2009

Study Record Updates

Last Update Posted (Estimate)

June 17, 2009

Last Update Submitted That Met QC Criteria

June 16, 2009

Last Verified

June 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 073/09

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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