Last Verified: | October/31/2019 |
First Submitted: | November/9/2019 |
Estimated Enrollment Submitted: | November/12/2019 |
First Posted: | November/13/2019 |
Last Update Submitted: | November/12/2019 |
Last Update Posted: | November/13/2019 |
Actual Study Start Date: | December/31/2016 |
Estimated Primary Completion Date: | February/28/2017 |
Estimated Study Completion Date: | April/30/2017 |
Study Type: | Interventional |
Allocation: | N/A |
: | Single arm study |
Primary Purpose: | Treatment |
Masking: | None (Open Label) |
Arm | Intervention/treatment |
---|---|
Experimental: Intervention In this single arm study subjects follow a low calorie mediterranean ketogenci diet | Other: Intervention The KEMEPHY diet (24-29) is a Mediterranean low calories ketogenic protocol (about 1000/1100 Kcal/day) with the use of some phytoextracts. During this protocol subjects are allowed to eat with no limits green leafy vegetables, cruciferous, zucchini, cucumbers and eggplants. The quantity of meat, eggs and fish was limited to once a day (120g of meat or 200g of fish or 1 egg) Table 1. Moreover, subjects daily consumed four food supplements and liquid herbal extracts. Food supplements are high proteins (19g/portion) and very low carbohydrate (3.5g/portion) formulas simulating the aspect and taste of common carbohydrate rich foods added with dry phytoextracts (30). Liquid herbal extracts were used for their draining /toning activity, useful to reduce some commonly reported light side effects of ketogenic diets as constipation, headache and halitosis. |
Ages Eligible for Study: | 18 Years to 18 Years |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Criteria: | Inclusion Criteria: diagnosis of PCOS according Rotterdam Criteria (at least 2 of 3 between - oligo/anovulation - hyperandrogenism - clinical (hirsutism or less commonly male pattern alopecia) or biochemical (raised FAI or free testosterone) polycystic ovaries on ultrasound Other inclusion criteria - fertile age (18-45 years); - BMI> 25 kg/m2, - desire to lose weight; - acceptance not to use contraceptives during the experimental period Exclusion Criteria: - pregnancy and lactation, - hormonal therapy and/or insulin-sensitizers in the last 2 months, - hepatic, renal and heart diseases |