NCT01400724

Inofolic NRT and the Metabolic Syndrome

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: University of Messina · Academic / Other
• Sex: Female
• Age: 50 Years – 60 Years
• Healthy volunteers: Accepted

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: 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

Conditions

• Metabolic Syndrome
• Postmenopausal Disorder

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Inofolic NRT	Dietary supplement: myo-inositol 2000 mg plus cocoa polyphenols 30 mg and plus isoflavones 80 mg

Timeline

• Start date: 2011-06-01
• Primary completion: 2012-07-01
• Completion: 2012-10-01
• First posted: 2011-07-22
• Last updated: 2013-07-16

Locations

1 site across 1 country: Italy