Inofolic NRT and the Metabolic Syndrome

Sponsor

University of Messina (Other)

Overall Status

Completed

CT.gov ID

NCT01400724

Collaborator

(none)

Enrollment

Location

Arm

Duration (Months)

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Metabolic Syndrome Postmenopausal Disorder	Dietary Supplement: Inofolic NRT	N/A

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

Study Design

Study Type:

Interventional

Actual Enrollment :

80 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Supportive Care

Official Title:

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

Study Start Date :

Jun 1, 2011

Actual Primary Completion Date :

Jul 1, 2012

Actual Study Completion Date :

Oct 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Inofolic NRT	Dietary Supplement: Inofolic NRT Dietary supplement: myo-inositol 2000 mg plus cocoa polyphenols 30 mg and plus isoflavones 80 mg

Arm

Intervention/Treatment

Experimental: Inofolic NRT

Dietary Supplement: Inofolic NRT

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

Outcome Measures

Primary Outcome Measures

percentage reduction of women with metabolic syndrome [at baseline and after 6 months.]
evaluation of metabolic syndrome criteria according with ATP III 2001

Secondary Outcome Measures

reduction of insulin resistance [at baseline and after 6 months]
evaluation of HOMA-IR
Improvement of lipid profile [at baseline and after 6 months]
reduction of serum triglycerides and increase of HDL-cholesterol
variation in serum concentration of adiponectin, visfatin and resistin [at baseline and after 6 months]