Effects of a Ketogenic Diet on PCOS Outcomes

Not Applicable

Completed

• Conditions: Polycystic Ovary Syndrome
• Interventions: Other: Low calorie Mediterranean ketogenic diet with phytoextracts (KEMEPHY)

• Registration Number: NCT04163120
• Lead Sponsor: University of Padova

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.

Study Timeline

• Study Start: 2017-01
• Primary Completion: 2017-03
• Study Completion: 2017-05
• Status Verified: 2019-11
• Study First Submitted: 2019-11-10
• Study First Submitted QC: 2019-11-13
• Last Update Submitted: 2019-11-13
• Study First Posted: 2019-11-14
• Last Update Posted: 2019-11-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 14

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intervention	Low calorie Mediterranean ketogenic diet with phytoextracts (KEMEPHY)	In this single arm study subjects follow a low calorie mediterranean ketogenci diet

Primary Outcome Measures

Name	Time	Method
Fat body mass	12 weeks	will be analysed by Dual X Ray Absorptiometry (DEXA) Hologic HorizonTM QDR RSeries Bedford, Massachusetts, USA
Body Weight	12 weeks	Body weight will be measured by an electronic scale
LH	after 12 weeks	LH will be measured by immunochemiluminescent method (Roche Cobas e601, Roche Diagnostics, Mannheim, Germany)
FSH	12 weeks	FSH will be measured by immunochemiluminescent method (Roche Cobas e601, Roche Diagnostics, Mannheim, Germany)
Total testosterone	12 weeks	Total testosterone will be measured by immunochemiluminescent method (Roche Cobas e601, Roche Diagnostics, Mannheim, Germany)
Insulin	12 weeks	Insulin will be measured by immunochemiluminescent method (Roche Cobas e601, Roche Diagnostics, Mannheim, Germany)
DHEAS	12 weeks	DHEAS will be measured by immunochemiluminescent method (Roche Cobas e601, Roche Diagnostics, Mannheim, Germany)
progesterone	12 weeks	progesterone will be measured by immunochemiluminescent method (Roche Cobas e601, Roche Diagnostics, Mannheim, Germany)
estradiol	12 weeks	estradiol will be measured by immunochemiluminescent method (Roche Cobas e601, Roche Diagnostics, Mannheim, Germany)
SHBG	12 weeks	SHBG will be measured by immunochemiluminescent method (Roche Cobas e601, Roche Diagnostics, Mannheim, Germany)
Hirsutism .	12 weeks	we will use Ferriman Gallwey Score. A score of 1 to 4 is given for nine areas of the body. A total score less than 8 is considered normal, a score of 8 to 15 indicates mild hirsutism, and a score greater than 15 indicates moderate or severe hirsutism. A score of 0 indicates absence of terminal hair.
HOMA	12 weeks	HOMA-IR will be calculated according to the formula "insulinemia (μU/mL) x glycemia (mmol/L)/22.5
blood glucose	12 weeks	blood glucose will be measured by enzymatic method with esokinase (Roche Cobas e702, Roche Diagnostics, Mannheim, Germany)

Secondary Outcome Measures

Name	Time	Method
Ketone bodies	12 weeks	Ketone bodies will be measured by Precision Xtra® Blood β-Ketone Test Strips and Precision Xtra® (28) (Abbott Laboratories, Illinois 60064-3500, USA)
total cholesterol	12 weeks	total cholesterol will be measured by enzymatic colorimetric in homogenous phase (Roche Cobas e702, Roche Diagnostics, Mannheim, Germany)
Triglycerides	12 weeks	TGs by an enzymatic colorimetric method (Roche Cobas e702, Roche Diagnostics, Mannheim, Germany)
HDL cholesterol	12 weeks	HDL cholesterol will be measured by enzymatic colorimetric in homogenous phase (Roche Cobas e702, Roche Diagnostics, Mannheim, Germany)
LDL cholesterol	12 weeks	LDL cholesterol will be measured by enzymatic colorimetric in homogenous phase (Roche Cobas e702, Roche Diagnostics, Mannheim, Germany)

Trial Locations

Locations (1)

Nutrition and Exercise Lab, DSB, University of Padova; 🇮🇹 Padova, Italy