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Effects of a Ketogenic Diet on PCOS Outcomes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04163120
Recruitment Status : Completed
First Posted : November 14, 2019
Last Update Posted : November 14, 2019
Sponsor:
Collaborators:
University of Palermo
Universita di Verona
Vita-Salute San Raffaele University
Information provided by (Responsible Party):
Antonio Paoli, University of Padova

Tracking Information
First Submitted Date  ICMJE November 10, 2019
First Posted Date  ICMJE November 14, 2019
Last Update Posted Date November 14, 2019
Actual Study Start Date  ICMJE January 2017
Actual Primary Completion Date March 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 13, 2019)
  • Body Weight [ Time Frame: 12 weeks ]
    Body weight will be measured by an electronic scale
  • Fat body mass [ Time Frame: 12 weeks ]
    will be analysed by Dual X Ray Absorptiometry (DEXA) Hologic HorizonTM QDR RSeries Bedford, Massachusetts, USA
  • LH [ Time Frame: after 12 weeks ]
    LH will be measured by immunochemiluminescent method (Roche Cobas e601, Roche Diagnostics, Mannheim, Germany)
  • FSH [ Time Frame: 12 weeks ]
    FSH will be measured by immunochemiluminescent method (Roche Cobas e601, Roche Diagnostics, Mannheim, Germany)
  • Total testosterone [ Time Frame: 12 weeks ]
    Total testosterone will be measured by immunochemiluminescent method (Roche Cobas e601, Roche Diagnostics, Mannheim, Germany)
  • Insulin [ Time Frame: 12 weeks ]
    Insulin will be measured by immunochemiluminescent method (Roche Cobas e601, Roche Diagnostics, Mannheim, Germany)
  • DHEAS [ Time Frame: 12 weeks ]
    DHEAS will be measured by immunochemiluminescent method (Roche Cobas e601, Roche Diagnostics, Mannheim, Germany)
  • progesterone [ Time Frame: 12 weeks ]
    progesterone will be measured by immunochemiluminescent method (Roche Cobas e601, Roche Diagnostics, Mannheim, Germany)
  • estradiol [ Time Frame: 12 weeks ]
    estradiol will be measured by immunochemiluminescent method (Roche Cobas e601, Roche Diagnostics, Mannheim, Germany)
  • SHBG [ Time Frame: 12 weeks ]
    SHBG will be measured by immunochemiluminescent method (Roche Cobas e601, Roche Diagnostics, Mannheim, Germany)
  • HOMA [ Time Frame: 12 weeks ]
    HOMA-IR will be calculated according to the formula "insulinemia (μU/mL) x glycemia (mmol/L)/22.5
  • blood glucose [ Time Frame: 12 weeks ]
    blood glucose will be measured by enzymatic method with esokinase (Roche Cobas e702, Roche Diagnostics, Mannheim, Germany)
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: November 13, 2019)
  • 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)
  • total cholesterol [ Time Frame: 12 weeks ]
    total cholesterol will be measured by enzymatic colorimetric in homogenous phase (Roche Cobas e702, Roche Diagnostics, Mannheim, Germany)
  • HDL cholesterol [ Time Frame: 12 weeks ]
    HDL cholesterol will be measured by enzymatic colorimetric in homogenous phase (Roche Cobas e702, Roche Diagnostics, Mannheim, Germany)
  • LDL cholesterol [ Time Frame: 12 weeks ]
    LDL cholesterol will be measured by enzymatic colorimetric in homogenous phase (Roche Cobas e702, Roche Diagnostics, Mannheim, Germany)
  • Triglycerides [ Time Frame: 12 weeks ]
    TGs by an enzymatic colorimetric method (Roche Cobas e702, Roche Diagnostics, Mannheim, Germany)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effects of a Ketogenic Diet on PCOS Outcomes
Official Title  ICMJE Effects of a Low Calorie Mediterranean Ketogenic Diet in Women With Polycystic Ovary Syndrome
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Intervention Model Description:
Single arm study
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Polycystic Ovary Syndrome
Intervention  ICMJE 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.
Study Arms  ICMJE Experimental: Intervention
In this single arm study subjects follow a low calorie mediterranean ketogenci diet
Intervention: Other: Low calorie Mediterranean ketogenic diet with phytoextracts (KEMEPHY)
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 13, 2019)
14
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 2017
Actual Primary Completion Date March 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Italy
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04163120
Other Study ID Numbers  ICMJE KDPCOS
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Antonio Paoli, University of Padova
Study Sponsor  ICMJE University of Padova
Collaborators  ICMJE
  • University of Palermo
  • Universita di Verona
  • Vita-Salute San Raffaele University
Investigators  ICMJE
Principal Investigator: Antonio Paoli, MD University of Padova
PRS Account University of Padova
Verification Date November 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP