INOSIDEX study: to determine whether the combination of inositol and alpha lipoic acid as supplementation of low calories diet can adjust metabolic syndrome parameters in post-menopausal wome
Completed
- Conditions
- Optimum control of insulin resistance and lipid profile in post-menopausal womenNutritional, Metabolic, Endocrine
- Registration Number
- ISRCTN74096908
- Lead Sponsor
- Pharma Dancan s.r.l. (Italy)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Female
- Target Recruitment
- 155
Inclusion Criteria
1. Post-menopausal women affected by metabolic syndrome at any age participating to our clinical-instrumental program of surveillance for breast cancer prevention
2. Willing to be assigned to any of the study intervention groups
Exclusion Criteria
1. Women taking oral hypoglycemic drugs or insulin
2. Women taking statins
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Reduction of more than 20% of HOMA-IR index and of triglycerides<br>2. Improvement of high density lipoprotein cholesterol <br>3. Reduction of anthropometric features such as body mass index, waist and hip ratio<br>Measured at at baseline and at six months.
- Secondary Outcome Measures
Name Time Method Good control of metabolic syndrome helping diet results with insulin sensitizing supplements