Vascular Effects of Hesperidin in Metabolic Syndrome

• Sponsor: University of Rome Tor Vergata (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT00914251
• Collaborator: (none)
• Enrollment: 30
• Location: 1
• Arms: 2
• Duration (Months): 25
• Patients Per Site Per Month: 1.2

Study Details

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
• Anticipated 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: Nov 1, 2008
• Actual Primary Completion Date: Mar 1, 2009
• Anticipated Study Completion Date: Dec 1, 2010

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 [3 weeks]

Secondary Outcome Measures

1. Endothelial function assessed by FMD %. Inflammatory status assessed by biochemical markers. [3 weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 55 Years
• 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

Locations

	Site	City	State	Country	Postal Code
1	University of Rome Tor Vergata	Rome		Italy	00133

Sponsors and Collaborators

• University of Rome Tor Vergata

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.
• 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.

• ClinicalTrials.gov Identifier: NCT00914251
• Other Study ID Numbers: 073/09
• First Posted: Jun 4, 2009
• Last Update Posted: Jun 17, 2009
• Last Verified: Jun 1, 2009

• Keywords provided by , ,: endothelial; metabolic syndrome; hesperidin
• Additional relevant MeSH terms: Metabolic Syndrome; Syndrome

Study Results

No Results Posted as of Jun 17, 2009