Metabolic Syndrome Clinical Trial
Official title:
Effects of Inofolic NRT on Post-menopausal Women Affected by the Metabolic Syndrome
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.
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
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Supportive Care
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