Inofolic NRT and the Metabolic Syndrome

Overview

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.

Full Title of Study: “Effects of Inofolic NRT on Post-menopausal Women Affected by the Metabolic Syndrome”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Supportive Care
    • Masking: Single (Participant)
  • Study Primary Completion Date: July 2012

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: 1. waist circumference > 88 cm 2. Triglycerides > 150 mg/dl 3. HDL-cholesterol < 50 mg/dl 4. Fast glycemia > 110 mg/dl 5. 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

Interventions

  • Dietary Supplement: Inofolic NRT
    • Dietary supplement: myo-inositol 2000 mg plus cocoa polyphenols 30 mg and plus isoflavones 80 mg

Arms, Groups and Cohorts

  • Experimental: Inofolic NRT

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

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

Participating in This Clinical Trial

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: 1. waist circumference > 88 cm 2. Triglycerides > 150 mg/dl 3. HDL-cholesterol < 50 mg/dl 4. Fast glycemia > 110 mg/dl 5. 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

Gender Eligibility: Female

Minimum Age: 50 Years

Maximum Age: 60 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • University of Messina
  • Provider of Information About this Clinical Study
    • Principal Investigator: Rosario D’anna, associate professor – University of Messina
  • Overall Official(s)
    • Rosario D’Anna, professor, Principal Investigator, University of Messina

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