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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

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.

Condition or disease Intervention/treatment Phase
Polycystic Ovary Syndrome Other: Low calorie Mediterranean ketogenic diet with phytoextracts (KEMEPHY) Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Single arm study
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effects of a Low Calorie Mediterranean Ketogenic Diet in Women With Polycystic Ovary Syndrome
Actual Study Start Date : January 2017
Actual Primary Completion Date : March 2017
Actual Study Completion Date : May 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Intervention
In this single arm study subjects follow a low calorie mediterranean ketogenci diet
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.




Primary Outcome Measures :
  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 Outcome Measures :
  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)



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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04163120


Locations
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Italy
Nutrition and Exercise Lab, DSB, University of Padova
Padova, Italy, 35131
Sponsors and Collaborators
University of Padova
University of Palermo
Universita di Verona
Vita-Salute San Raffaele University
Investigators
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Principal Investigator: Antonio Paoli, MD University of Padova

Publications:
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Responsible Party: Antonio Paoli, Professor, University of Padova
ClinicalTrials.gov Identifier: NCT04163120     History of Changes
Other Study ID Numbers: KDPCOS
First Posted: November 14, 2019    Key Record Dates
Last Update Posted: November 14, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Polycystic Ovary Syndrome
Syndrome
Disease
Pathologic Processes
Ovarian Cysts
Cysts
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases