Vascular Effects of Hesperidin in Metabolic Syndrome | NCT00914251

Studies
Vascular Effects of Hesperidin in Metabolic Syndrome

NCT00914251

Sponsor

University of Rome Tor Vergata

Status

Unknown status

Last Update Posted

Jun 17, 2009Estimated

Enrollment

30Estimated

Phase

Phase 2

Conditions

Endothelial Dysfunction
Metabolic Syndrome

Interventions

Hesperidin
Placebo

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2009

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2008

Primary Completion Date

Mar 2009Actual

Completion Date

Dec 2010Estimated

First Submitted Date

Jun 3, 2009

First Submission Date that Met QC Criteria

Jun 3, 2009

First Posted Date

Jun 4, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 16, 2009

Last Update Posted Date

Jun 17, 2009Estimated

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Hesperidin, 500 mg per day	Active Comparator	500 mg daily of oral Hesperidin for 3 weeks	Drug: Hesperidin
Placebo	Placebo Comparator		Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Hesperidin	Drug	Administration of oral Hesperidin, 500 mg/daily	Hesperidin, 500 mg per day

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Safety of oral supplementation of hesperidin		3 weeks

Secondary Outcomes

Measure	Description	Time Frame
Endothelial function assessed by FMD %. Inflammatory status assessed by biochemical markers.		3 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

55 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Rome Tor Vergata	Recruiting	Rome	Rome	00133	Italy

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
19064532	Background	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.
17724029	Background

ID	Term
D007333	Insulin Resistance
D006946	Hyperinsulinism
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases

ID	Term
D044950	Flavanones
D005419	Flavonoids
D002867	Chromones
D001578	Benzopyrans
D011714