Vascular Effects of Hesperidin in Metabolic Syndrome

Metabolic Syndrome Clinical Trial

Official title:

Positive Vascular Effect of Hesperidin in Subjects Affected by Metabolic Syndrome

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00914251
• Other study ID #: 073/09
• Status: Recruiting
• Phase: Phase 2
• First received: June 3, 2009
• Last updated: June 16, 2009
• Start date: November 2008
• Est. completion date: December 2010

Study information

• Verified date: June 2009
• Source: University of Rome Tor Vergata
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 2010
• Est. primary completion date: March 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 55 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Endothelial Dysfunction
• Metabolic Syndrome
• Metabolic Syndrome X
• Syndrome

Intervention

Drug:
• Hesperidin
Administration of oral Hesperidin, 500 mg/daily
• Placebo
Administration of oral Placebo, 500 mg/daily

Locations

Country	Name	City	State
Italy	University of Rome Tor Vergata	Rome

Sponsors (1)

Lead Sponsor	Collaborator
University of Rome Tor Vergata

Country where clinical trial is conducted

Italy, 

References & Publications (2)

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. — View Citation

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. doi: 10.3945/ajcn.2008.26457. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety of oral supplementation of hesperidin		3 weeks	Yes
Secondary	Endothelial function assessed by FMD %. Inflammatory status assessed by biochemical markers.		3 weeks	No