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Completed

NCT Number: NCT04163120

Effects of a Ketogenic Diet on PCOS Outcomes

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

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Key information

Conditions

Polycystic Ovary Syndrome Adnexal Diseases Cysts Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Gonadal Disorders Neoplasms Ovarian Cysts Ovarian Diseases Urogenital Diseases

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Nutrition and Exercise Lab, DSB, University of Padova

Padova, 35131, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Low calorie Mediterranean ketogenic diet with phytoextracts (KEMEPHY)

Other

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.

Primary outcomes

  1. Body Weight

    Time frame: 12 weeks

    Body weight will be measured by an electronic scale

  2. Fat body mass

    Time frame: 12 weeks

    will be analysed by Dual X Ray Absorptiometry (DEXA) Hologic HorizonTM QDR RSeries Bedford, Massachusetts, USA

  3. LH

    Time frame: after 12 weeks

    LH will be measured by immunochemiluminescent method (Roche Cobas e601, Roche Diagnostics, Mannheim, Germany)

  4. FSH

    Time frame: 12 weeks

    FSH will be measured by immunochemiluminescent method (Roche Cobas e601, Roche Diagnostics, Mannheim, Germany)

  5. Total testosterone

    Time frame: 12 weeks

    Total testosterone will be measured by immunochemiluminescent method (Roche Cobas e601, Roche Diagnostics, Mannheim, Germany)

  6. Insulin

    Time frame: 12 weeks

    Insulin will be measured by immunochemiluminescent method (Roche Cobas e601, Roche Diagnostics, Mannheim, Germany)

  7. DHEAS

    Time frame: 12 weeks

    DHEAS will be measured by immunochemiluminescent method (Roche Cobas e601, Roche Diagnostics, Mannheim, Germany)

  8. progesterone

    Time frame: 12 weeks

    progesterone will be measured by immunochemiluminescent method (Roche Cobas e601, Roche Diagnostics, Mannheim, Germany)

  9. estradiol

    Time frame: 12 weeks

    estradiol will be measured by immunochemiluminescent method (Roche Cobas e601, Roche Diagnostics, Mannheim, Germany)

  10. SHBG

    Time frame: 12 weeks

    SHBG will be measured by immunochemiluminescent method (Roche Cobas e601, Roche Diagnostics, Mannheim, Germany)

  11. HOMA

    Time frame: 12 weeks

    HOMA-IR will be calculated according to the formula "insulinemia (μU/mL) x glycemia (mmol/L)/22.5

  12. blood glucose

    Time frame: 12 weeks

    blood glucose will be measured by enzymatic method with esokinase (Roche Cobas e702, Roche Diagnostics, Mannheim, Germany)

  13. Hirsutism .

    Time frame: 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.

Secondary outcomes

  1. Ketone bodies

    Time frame: 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)

  2. total cholesterol

    Time frame: 12 weeks

    total cholesterol will be measured by enzymatic colorimetric in homogenous phase (Roche Cobas e702, Roche Diagnostics, Mannheim, Germany)

  3. HDL cholesterol

    Time frame: 12 weeks

    HDL cholesterol will be measured by enzymatic colorimetric in homogenous phase (Roche Cobas e702, Roche Diagnostics, Mannheim, Germany)

  4. LDL cholesterol

    Time frame: 12 weeks

    LDL cholesterol will be measured by enzymatic colorimetric in homogenous phase (Roche Cobas e702, Roche Diagnostics, Mannheim, Germany)

  5. Triglycerides

    Time frame: 12 weeks

    TGs by an enzymatic colorimetric method (Roche Cobas e702, Roche Diagnostics, Mannheim, Germany)

Sponsors and collaborators

Lead sponsor

University of Padova

Other

Collaborators

  • Universita di Verona
  • University of Palermo
  • Università Vita-Salute San Raffaele

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Nov 14, 2019
Registry last updated
Nov 14, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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