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Inofolic NRT and the Metabolic Syndrome

Primary Purpose

Metabolic Syndrome, Postmenopausal Disorder

Status

Completed

Phase

Not Applicable

Locations

Italy

Study Type

Interventional

Intervention

Inofolic NRT

About this trial

This is an interventional supportive care trial for Metabolic Syndrome focused on measuring menopause, metabolic syndrome, myo-inositol, insulin resistance, cocoa polyphenols, isoflavones

Eligibility Criteria

50 Years - 60 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Inofolic NRT

Arm Description

Outcomes

Primary Outcome Measures

percentage reduction of women with metabolic syndrome

evaluation of metabolic syndrome criteria according with ATP III 2001

Secondary Outcome Measures

reduction of insulin resistance

evaluation of HOMA-IR

Improvement of lipid profile

reduction of serum triglycerides and increase of HDL-cholesterol

variation in serum concentration of adiponectin, visfatin and resistin

Full Information

NCT ID

NCT01400724

First Posted

July 14, 2011

Last Updated

July 15, 2013

Sponsor

University of Messina

1. Study Identification

Unique Protocol Identification Number

NCT01400724

Brief Title

Inofolic NRT and the Metabolic Syndrome

Official Title

Effects of Inofolic NRT on Post-menopausal Women Affected by the Metabolic Syndrome

Study Type

Interventional

2. Study Status

Record Verification Date

July 2013

Overall Recruitment Status

Completed

Study Start Date

June 2011 (undefined)

Primary Completion Date

July 2012 (Actual)

Study Completion Date

October 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Messina

4. Oversight

Data Monitoring Committee

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Metabolic Syndrome, Postmenopausal Disorder

Keywords

menopause, metabolic syndrome, myo-inositol, insulin resistance, cocoa polyphenols, isoflavones

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

80 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Inofolic NRT

Arm Type

Experimental

Intervention Type

Dietary Supplement

Intervention Name(s)

Inofolic NRT

Intervention Description

Dietary supplement: myo-inositol 2000 mg plus cocoa polyphenols 30 mg and plus isoflavones 80 mg

Primary Outcome Measure Information:

Title

percentage reduction of women with metabolic syndrome

Description

evaluation of metabolic syndrome criteria according with ATP III 2001

Time Frame

at baseline and after 6 months.

Secondary Outcome Measure Information:

Title

reduction of insulin resistance

Description

evaluation of HOMA-IR

Time Frame

at baseline and after 6 months

Title

Improvement of lipid profile

Description

reduction of serum triglycerides and increase of HDL-cholesterol

Time Frame

at baseline and after 6 months

Title

variation in serum concentration of adiponectin, visfatin and resistin

Time Frame

at baseline and after 6 months

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

50 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Rosario D'Anna, professor

Organizational Affiliation

University of Messina

Official's Role

Principal Investigator

Facility Information:

Facility Name

University Hospital

City

Messina

ZIP/Postal Code

98100

Country

Italy

12. IPD Sharing Statement

Citations:

PubMed Identifier

25254044

Citation

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.

Results Reference

derived

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Inofolic NRT and the Metabolic Syndrome

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