Vascular Effects of Hesperidin in Metabolic Syndrome
Positive Vascular Effect of Hesperidin in Subjects Affected by Metabolic Syndrome
1 other identifier
interventional
30
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Nov 2008
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2009
CompletedFirst Submitted
Initial submission to the registry
June 3, 2009
CompletedFirst Posted
Study publicly available on registry
June 4, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2010
CompletedJune 17, 2009
June 1, 2009
4 months
June 3, 2009
June 16, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Safety of oral supplementation of hesperidin
3 weeks
Secondary Outcomes (1)
Endothelial function assessed by FMD %. Inflammatory status assessed by biochemical markers.
3 weeks
Study Arms (2)
Hesperidin, 500 mg per day
ACTIVE COMPARATOR500 mg daily of oral Hesperidin for 3 weeks
Placebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Metabolic Syndrome (ATPIII criteria)
- BMI \<35
- Age 20-55
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Rome Tor Vergata
Rome, Rome, 00133, Italy
Related Publications (3)
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.
PMID: 19064532BACKGROUNDCollins 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.
PMID: 17724029BACKGROUNDRizza 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.
PMID: 21346065DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
June 3, 2009
First Posted
June 4, 2009
Study Start
November 1, 2008
Primary Completion
March 1, 2009
Study Completion
December 1, 2010
Last Updated
June 17, 2009
Record last verified: 2009-06