Effects of a Ketogenic Diet on PCOS Outcomes

Polycystic Ovary Syndrome Clinical Trial

Official title:

Effects of a Low Calorie Mediterranean Ketogenic Diet in Women With Polycystic Ovary Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04163120
• Other study ID #: KDPCOS
• Status: Completed
• Phase: N/A
• Start date: January 2017
• Est. completion date: May 2017

Study information

• Verified date: November 2019
• Source: University of Padova
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: May 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Polycystic Ovary Syndrome
• Syndrome

Intervention

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

Locations

Country	Name	City	State
Italy	Nutrition and Exercise Lab, DSB, University of Padova	Padova

Sponsors (4)

Lead Sponsor	Collaborator
University of Padova	Universita di Verona, University of Palermo, Vita-Salute San Raffaele University

Country where clinical trial is conducted

Italy, 

References & Publications (5)

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. Epub 2007 Apr 4. — View 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. — View 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. Review. — View 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). pii: E534. doi: 10.3390/genes10070534. Review. — View 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. Review. Erratum in: Eur J Clin Nutr. 2014 May;68(5):641. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Body Weight	Body weight will be measured by an electronic scale	12 weeks
Primary	Fat body mass	will be analysed by Dual X Ray Absorptiometry (DEXA) Hologic HorizonTM QDR RSeries Bedford, Massachusetts, USA	12 weeks
Primary	LH	LH will be measured by immunochemiluminescent method (Roche Cobas e601, Roche Diagnostics, Mannheim, Germany)	after 12 weeks
Primary	FSH	FSH will be measured by immunochemiluminescent method (Roche Cobas e601, Roche Diagnostics, Mannheim, Germany)	12 weeks
Primary	Total testosterone	Total testosterone will be measured by immunochemiluminescent method (Roche Cobas e601, Roche Diagnostics, Mannheim, Germany)	12 weeks
Primary	Insulin	Insulin will be measured by immunochemiluminescent method (Roche Cobas e601, Roche Diagnostics, Mannheim, Germany)	12 weeks
Primary	DHEAS	DHEAS will be measured by immunochemiluminescent method (Roche Cobas e601, Roche Diagnostics, Mannheim, Germany)	12 weeks
Primary	progesterone	progesterone will be measured by immunochemiluminescent method (Roche Cobas e601, Roche Diagnostics, Mannheim, Germany)	12 weeks
Primary	estradiol	estradiol will be measured by immunochemiluminescent method (Roche Cobas e601, Roche Diagnostics, Mannheim, Germany)	12 weeks
Primary	SHBG	SHBG will be measured by immunochemiluminescent method (Roche Cobas e601, Roche Diagnostics, Mannheim, Germany)	12 weeks
Primary	HOMA	HOMA-IR will be calculated according to the formula "insulinemia (µU/mL) x glycemia (mmol/L)/22.5	12 weeks
Primary	blood glucose	blood glucose will be measured by enzymatic method with esokinase (Roche Cobas e702, Roche Diagnostics, Mannheim, Germany)	12 weeks
Primary	Hirsutism .	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.	12 weeks
Secondary	Ketone bodies	Ketone bodies will be measured by Precision Xtra® Blood ß-Ketone Test Strips and Precision Xtra® (28) (Abbott Laboratories, Illinois 60064-3500, USA)	12 weeks
Secondary	total cholesterol	total cholesterol will be measured by enzymatic colorimetric in homogenous phase (Roche Cobas e702, Roche Diagnostics, Mannheim, Germany)	12 weeks
Secondary	HDL cholesterol	HDL cholesterol will be measured by enzymatic colorimetric in homogenous phase (Roche Cobas e702, Roche Diagnostics, Mannheim, Germany)	12 weeks
Secondary	LDL cholesterol	LDL cholesterol will be measured by enzymatic colorimetric in homogenous phase (Roche Cobas e702, Roche Diagnostics, Mannheim, Germany)	12 weeks
Secondary	Triglycerides	TGs by an enzymatic colorimetric method (Roche Cobas e702, Roche Diagnostics, Mannheim, Germany)	12 weeks