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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