Effects of a Ketogenic Diet on PCOS Outcomes

University of Padova

Status: Completed

Conditions: Polycystic Ovary Syndrome

Treatments: Other: Low calorie Mediterranean ketogenic diet with phytoextracts (KEMEPHY)

Study type: Interventional

Funder types: Other

Identifiers

NCT04163120

KDPCOS

Details and patient eligibility

About

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

Full 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.

Enrollment: 14 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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14 participants in 1 patient group

Intervention

Experimental group

Description:

In this single arm study subjects follow a low calorie mediterranean ketogenci diet

Treatment:

Other: Low calorie Mediterranean ketogenic diet with phytoextracts (KEMEPHY)