Metabolic Syndrome, Postmenopausal Disorder
Conditions
Keywords
menopause, metabolic syndrome, myo-inositol, insulin resistance, cocoa polyphenols, isoflavones
Brief 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
Interventions
Dietary supplement: myo-inositol 2000 mg plus cocoa polyphenols 30 mg and plus isoflavones 80 mg
Sponsors
Study design
Eligibility
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| percentage reduction of women with metabolic syndrome | at baseline and after 6 months. | evaluation of metabolic syndrome criteria according with ATP III 2001 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| reduction of insulin resistance | at baseline and after 6 months | evaluation of HOMA-IR |
| Improvement of lipid profile | at baseline and after 6 months | reduction of serum triglycerides and increase of HDL-cholesterol |
| variation in serum concentration of adiponectin, visfatin and resistin | at baseline and after 6 months | — |
Countries
Italy