Effects of a Ketogenic Diet on PCOS Outcomes
Ключови думи
Резюме
Описание
Fourteen overweight women with diagnosis of Polycystic Ovary Syndrome (PCOS) will undergo to a low calorie ketogenic Mediterranean diet with phyoextracts (KEMEPHY) for 12 week. Changes in body weight, body mass index (BMI), fat body mass (FBM), lean body mass (LBM), visceral adipose tissue (VAT), insulin, glucose, HOMA-IR, total cholesterol, low density lipoprotein (LDL), high density lipoprotein (HDL(, triglycerides (TGs), total and free testosterone, luteinizing hormone (LH), follicle stimulating hormone (FSH); dehydroepiandrosterone sulfate (DHEAs), estradiol, progesterone, sex hormone binding globulin (SHBG) and Ferriman Gallwey score will be evaluated.
Дати
| Последна проверка: | 10/31/2019 |
| Първо изпратено: | 11/09/2019 |
| Очаквано записване подадено: | 11/12/2019 |
| Първо публикувано: | 11/13/2019 |
| Изпратена последна актуализация: | 11/12/2019 |
| Последна актуализация публикувана: | 11/13/2019 |
| Действителна начална дата на проучването: | 12/31/2016 |
| Приблизителна дата на първично завършване: | 02/28/2017 |
| Очаквана дата на завършване на проучването: | 04/30/2017 |
Състояние или заболяване
Интервенция / лечение
Other: Intervention
Фаза
Групи за ръце
| Arm | Интервенция / лечение |
|---|---|
| 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. |
Критерии за допустимост
| Възрасти, отговарящи на условията за проучване | 18 Years Да се 18 Years |
| Полове, допустими за проучване | Female |
| Приема здрави доброволци | Да |
| Критерии | 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 |
Резултат
Първични изходни мерки
1. Body Weight [12 weeks]
2. Fat body mass [12 weeks]
3. LH [after 12 weeks]
4. FSH [12 weeks]
5. Total testosterone [12 weeks]
6. Insulin [12 weeks]
7. DHEAS [12 weeks]
8. progesterone [12 weeks]
9. estradiol [12 weeks]
10. SHBG [12 weeks]
11. HOMA [12 weeks]
12. blood glucose [12 weeks]
13. Hirsutism . [12 weeks]
Вторични изходни мерки
1. Ketone bodies [12 weeks]
2. total cholesterol [12 weeks]
3. HDL cholesterol [12 weeks]
4. LDL cholesterol [12 weeks]
5. Triglycerides [12 weeks]
