Vascular Effects of Hesperidin in Metabolic Syndrome

This study is currently recruiting participants.

Verified by University of Rome Tor Vergata, June 2009

First Received: June 3, 2009 Last Updated: June 16, 2009 History of Changes

Sponsored by:	University of Rome Tor Vergata
Information provided by:	University of Rome Tor Vergata
ClinicalTrials.gov Identifier:	NCT00914251

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 II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Subject), Placebo Control, Crossover Assignment, Safety/Efficacy Study
Official Title:	Positive Vascular Effect of Hesperidin in Subjects Affected by Metabolic Syndrome

Resource links provided by NLM:

Drug Information available for: Hesperidin

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

Muniyappa R, Hall G, Kolodziej TL, Karne RJ, Crandon SK, Quon MJ. Cocoa consumption for 2 wk enhances insulin-mediated vasodilatation without improving blood pressure or insulin resistance in essential hypertension. Am J Clin Nutr. 2008 Dec;88(6):1685-96.

Collins QF, Liu HY, Pi J, Liu Z, Quon MJ, Cao W. Epigallocatechin-3-gallate (EGCG), a green tea polyphenol, suppresses hepatic gluconeogenesis through 5'-AMP-activated protein kinase. J Biol Chem. 2007 Oct 12;282(41):30143-9. Epub 2007 Aug 27.

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

Keywords provided by University of Rome Tor Vergata:

endothelial
metabolic syndrome
hesperidin

Study placed in the following topic categories:

Hesperidin

Additional relevant MeSH terms:

Pathologic Processes
Disease
Syndrome

ClinicalTrials.gov processed this record on September 03, 2009