Vascular Effects of Hesperidin in Metabolic Syndrome

NCT ID: NCT00914251

Last Updated: 2009-06-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-11-30

Study Completion Date

2010-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Endothelial Dysfunction Metabolic Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Hesperidin, 500 mg per day

500 mg daily of oral Hesperidin for 3 weeks

Group Type ACTIVE_COMPARATOR

Hesperidin

Intervention Type DRUG

Administration of oral Hesperidin, 500 mg/daily

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Administration of oral Placebo, 500 mg/daily

Interventions

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Hesperidin

Administration of oral Hesperidin, 500 mg/daily

Intervention Type DRUG

Placebo

Administration of oral Placebo, 500 mg/daily

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Rome Tor Vergata

OTHER

Sponsor Role lead

Responsible Party

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Medicine Internal Department

Locations

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University of Rome Tor Vergata

Rome, Rome, Italy

Site Status RECRUITING

Countries

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Italy

Facility Contacts

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Stefano Rizza, MD

Role: primary

References

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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.

Reference Type BACKGROUND
PMID: 19064532 (View on PubMed)

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. doi: 10.1074/jbc.M702390200. Epub 2007 Aug 27.

Reference Type BACKGROUND
PMID: 17724029 (View on PubMed)

Rizza S, Muniyappa R, Iantorno M, Kim JA, Chen H, Pullikotil P, Senese N, Tesauro M, Lauro D, Cardillo C, Quon MJ. Citrus polyphenol hesperidin stimulates production of nitric oxide in endothelial cells while improving endothelial function and reducing inflammatory markers in patients with metabolic syndrome. J Clin Endocrinol Metab. 2011 May;96(5):E782-92. doi: 10.1210/jc.2010-2879. Epub 2011 Feb 23.

Reference Type DERIVED
PMID: 21346065 (View on PubMed)

Other Identifiers

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073/09

Identifier Type: -

Identifier Source: org_study_id

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