Clinical trial NCT04163120: Effects of a Ketogenic Diet on PCOS Outcomes
Official title: Effects of a Low Calorie Mediterranean Ketogenic Diet in Women With Polycystic Ovary Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Polycystic Ovary Syndrome
Lead sponsor: University of Padova
Sponsor class: OTHER
Collaborators: name: University of Palermo
name: Universita di Verona
name: Vita-Salute San Raffaele University
First posted: 2019-11-14
Enrollment: 14
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single arm study
Primary purpose: TREATMENT

Brief summary: The aim of the study is to investigate the effects of a low calorie Mediterranean ketogenic diet on Polycystic Ovary Syndrome (PCOS) related outcomes.

Detailed description: 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.

Eligibility 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

Primary outcomes:
measure: Body Weight
timeFrame: 12 weeks
measure: Fat body mass
timeFrame: 12 weeks
measure: LH
timeFrame: after 12 weeks
measure: FSH
timeFrame: 12 weeks
measure: Total testosterone
timeFrame: 12 weeks
measure: Insulin
timeFrame: 12 weeks
measure: DHEAS
timeFrame: 12 weeks
measure: progesterone
timeFrame: 12 weeks
measure: estradiol
timeFrame: 12 weeks
measure: SHBG
timeFrame: 12 weeks
measure: HOMA
timeFrame: 12 weeks
measure: blood glucose
timeFrame: 12 weeks
measure: Hirsutism .
timeFrame: 12 weeks
Secondary outcomes:
measure: Ketone bodies
timeFrame: 12 weeks
measure: total cholesterol
timeFrame: 12 weeks
measure: HDL cholesterol
timeFrame: 12 weeks
measure: LDL cholesterol
timeFrame: 12 weeks
measure: Triglycerides
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Padova
country: Italy
facility: Nutrition and Exercise Lab, DSB, University of Padova
Study officials:
affiliation: University of Padova
name: Antonio Paoli, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Paoli A, Grimaldi K, Toniolo L, Canato M, Bianco A, Fratter A. Nutrition and acne: therapeutic potential of ketogenic diets. Skin Pharmacol Physiol. 2012;25(3):111-7. doi: 10.1159/000336404. Epub 2012 Feb 11.
citation: Paoli A, Rubini A, Volek JS, Grimaldi KA. Beyond weight loss: a review of the therapeutic uses of very-low-carbohydrate (ketogenic) diets. Eur J Clin Nutr. 2013 Aug;67(8):789-96. doi: 10.1038/ejcn.2013.116. Epub 2013 Jun 26.
citation: Paoli A, Mancin L, Bianco A, Thomas E, Mota JF, Piccini F. Ketogenic Diet and Microbiota: Friends or Enemies? Genes (Basel). 2019 Jul 15;10(7):534. doi: 10.3390/genes10070534.
citation: Mavropoulos JC, Yancy WS, Hepburn J, Westman EC. The effects of a low-carbohydrate, ketogenic diet on the polycystic ovary syndrome: a pilot study. Nutr Metab (Lond). 2005 Dec 16;2:35. doi: 10.1186/1743-7075-2-35.
citation: Galletly C, Moran L, Noakes M, Clifton P, Tomlinson L, Norman R. Psychological benefits of a high-protein, low-carbohydrate diet in obese women with polycystic ovary syndrome--a pilot study. Appetite. 2007 Nov;49(3):590-3. doi: 10.1016/j.appet.2007.03.222. Epub 2007 Apr 4.
citation: Paoli A, Mancin L, Giacona MC, Bianco A, Caprio M. Effects of a ketogenic diet in overweight women with polycystic ovary syndrome. J Transl Med. 2020 Feb 27;18(1):104. doi: 10.1186/s12967-020-02277-0.