Inofolic NRT and the Metabolic Syndrome

Study Overview
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Brief Summary
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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
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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

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

Conditions
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Metabolic Syndrome, Postmenopausal Disorder

Intervention / Treatment
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* Dietary Supplement: Inofolic NRT


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Inofolic NRT<br> | Dietary Supplement: Inofolic NRT<br>* Dietary supplement: myo-inositol 2000 mg plus cocoa polyphenols 30 mg and plus isoflavones 80 mg<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 Outcome Measures

| Outcome Measure | 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 | at baseline and after 6 months | 
| variation in serum concentration of adiponectin, visfatin and resistin |  | at baseline and after 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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menopause, metabolic syndrome, myo-inositol, insulin resistance, cocoa polyphenols, isoflavones