Inofolic NRT and the Metabolic Syndrome | NCT01400724

Studies
Inofolic NRT and the Metabolic Syndrome

NCT01400724

Sponsor

University of Messina

Status

Completed

Last Update Posted

Jul 16, 2013Estimated

Enrollment

80Actual

Phase

Not Applicable

Conditions

Metabolic Syndrome
Postmenopausal Disorder

Interventions

Inofolic NRT

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

ID	Type	Description	Link
NRT-LO.LI	Other Grant/Funding Number	LO.LI Pharma

Status Module

Record Verification Date

Jul 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2011

Primary Completion Date

Jul 2012Actual

Completion Date

Oct 2012Actual

First Submitted Date

Jul 14, 2011

First Submission Date that Met QC Criteria

Jul 21, 2011

First Posted Date

Jul 22, 2011Estimated

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

Jul 15, 2013

Last Update Posted Date

Jul 16, 2013Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Rosario D'anna, associate professor, University of MessinaPrincipal Investigator

Lead Sponsor

University of MessinaOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

A prospective, randomized, controlled, open-label study will be carried out on 80 post-menopausal women affected by the metabolic syndrome (criteria are described in NIH ATP III). After a written informed consent, women will be randomly treated for 6 months with hypocaloric diet (control group) or with diet and a supplementation of myo-inositol 2000 mg plus cocoa polyphenols 30 mg and plus isoflavones 80 mg. will be given randomly Eighty post-menopausal women, affected by metabolic syndrome will be randomized into two groups: 40 treated with myo-inositol 2 g twice per day and forty treated with placebo for six months. The investigators hypothesize that the administration of myo-inositol would improve the insulin-receptor activity in these women, reducing insulin resistance.

Detailed Description

Inclusion Criteria: post-menopausal women (12 months after last menstruation) affected by metabolic syndrome according to ATP III, 2001.

At least 3 of following 5 criteria must be present:

waist circumference > 88 cm
Triglycerides > 150 mg/dl
HDL-cholesterol < 50 mg/dl
Fast glycemia > 110 mg/dl
Systolic blood pressure > 135 mmHg. diastolic > 85 mmHg -

Exclusion Criteria:1) post-menopausal women with less than 12 months from the last menstruation 2) less than 3 criteria according with ATP III 3) TSH > 3.5 4) in treatment with drugs lowering glycemia or cholesterol 5) allergy to cocoa

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

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

80Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Inofolic NRT	Experimental		Dietary Supplement: Inofolic NRT

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Inofolic NRT	Dietary Supplement	Dietary supplement: myo-inositol 2000 mg plus cocoa polyphenols 30 mg and plus isoflavones 80 mg	Inofolic NRT

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
percentage reduction of women with metabolic syndrome	evaluation of metabolic syndrome criteria according with ATP III 2001	at baseline and after 6 months.

Secondary Outcomes

Measure	Description	Time Frame
reduction of insulin resistance	evaluation of HOMA-IR	at baseline and after 6 months
Improvement of lipid profile	reduction of serum triglycerides and increase of HDL-cholesterol

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria: post-menopausal women (12 months after last menstruation) affected by metabolic syndrome according to ATP III, 2001.

At least 3 of following 5 criteria must be present:

waist circumference > 88 cm
Triglycerides > 150 mg/dl
HDL-cholesterol < 50 mg/dl
Fast glycemia > 110 mg/dl
Systolic blood pressure > 135 mmHg. diastolic > 85 mmHg -

Exclusion Criteria:

post-menopausal women with less than 12 months from the last menstruation
less than 3 criteria according with ATP III
TSH > 3.5
in treatment with drugs lowering glycemia or cholesterol
allergy to cocoa

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

50 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Rosario D'Anna, professor	University of Messina	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospital		Messina		98100	Italy

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
25254044	Derived	D'Anna R, Santamaria A, Cannata ML, Interdonato ML, Giorgianni GM, Granese R, Corrado F, Bitto A. Effects of a new flavonoid and Myo-inositol supplement on some biomarkers of cardiovascular risk in postmenopausal women: a randomized trial. Int J Endocrinol. 2014;2014:653561. doi: 10.1155/2014/653561. Epub 2014 Aug 31.

ID	Term
D024821	Metabolic Syndrome
D007333	Insulin Resistance

ID	Term
D006946	Hyperinsulinism
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases