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Role of the Ketogenic Diet in Women With PCOS

Primary Purpose

Polycystic Ovary Syndrome

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
ketogenic diet
caloric diet with Metformin
caloric diet
Sponsored by
National Research Centre, Egypt
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Polycystic Ovary Syndrome

Eligibility Criteria

16 Years - 35 Years (Child, Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  1. Age range between 16-35 years.
  2. BMI ≥ 27.
  3. Normal Renal Function.
  4. Rotterdam criteria for the diagnosis of polycystic ovary syndrome:

    • Oligo/anovulation
    • Hyperandrogenism
    • Polycystic ovaries on ultrasound.

Exclusion Criteria:

  1. Age <16 or >35 years.
  2. BMI < 27.
  3. Pregnancy.
  4. Major medical disorders or other concurrent medical illnesses e.g. DM, other causes of androgen excess and hypercholesteremia
  5. Current or previous use of hormonal, anti-diabetic or anti-obesity drugs, or other drugs that affect hormone levels, carbohydrate metabolism or appetite.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    Experimental

    Arm Label

    Group 1

    Group 2

    Group 3

    Arm Description

    PCO patients that will receive ketogenic diet only

    PCO patients that will receive caloric diet with Metformin

    PCO patients that will receive caloric diet only

    Outcomes

    Primary Outcome Measures

    Role of the ketogenic diet in restoring normal ovulation that will be assessed by serial transvaginal ultrasound.
    To evaluate the role of the ketogenic diet in overweight and obese women with PCOS regarding ovulation that will be assessed by serial transvaginal ultrasound.
    comparison between ketogenic diet, caloric diet and caloric diet with Metformin regarding ovulation that will be assessed by serial transvaginal ultrasound.
    comparison between ketogenic diet, caloric diet and caloric diet with Metformin regarding ovulation that will be assessed by serial transvaginal ultrasound.

    Secondary Outcome Measures

    Role of the ketogenic diet in the affection of testosterone level
    To evaluate the role of the ketogenic diet in the affection of testosterone level in overweight and obese women with PCOS
    comparison between ketogenic diet, caloric diet and caloric diet with Metformin regarding testosterone level
    comparison between ketogenic diet, caloric diet and caloric diet with Metformin regarding testosterone level

    Full Information

    First Posted
    November 15, 2019
    Last Updated
    October 2, 2022
    Sponsor
    National Research Centre, Egypt
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04175964
    Brief Title
    Role of the Ketogenic Diet in Women With PCOS
    Official Title
    Role of the Ketogenic Diet in Women With PCOS
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    December 1, 2022 (Anticipated)
    Primary Completion Date
    April 30, 2023 (Anticipated)
    Study Completion Date
    June 30, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    National Research Centre, Egypt

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    For the fact of PCOS symptoms could be improved with weight loss and improving insulin resistance, the investigators will do this study to evaluate the role of the ketogenic diet in overweight and obese women with PCOS.
    Detailed Description
    Polycystic ovary syndrome (PCOS) is one of the most common endocrinal abnormalities that affect females within the reproductive age, and are found in about 4% of women. PCOS is commonly associated with symptoms of increased testosterone such as irregular or absent menstrual cycle, increased body hair, and infertility. PCOS is also associated with other disorders such as obesity, insulin resistance, hyperinsulinemia, diabetes mellitus type 2, and dyslipidemia. Until now, there is no known curative treatment for PCOS. However, anti-diabetic medications can improve many metabolic disorders such as insulin resistance, and increased levels of serum testosterone and total cholesterol. In addition, regulation of diet with exercise could improve the insulin sensitivity. Therefore, managements that aim to decrease the insulin level, improve the insulin resistance and decrease the body weight may be useful for improving symptoms of PCOS. Ketogenic diets are characterized by a reduction in carbohydrates (usually to less than 50 g/day) and a relative increase in the proportions of protein and fat. People following the keto diet gain 75% of their calories from fat, 20% from protein, and 5% from carbohydrates. Previous studies have revealed that the ketogenic diet of low carbohydrate could decrease the body weight and improve the insulin resistance.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Polycystic Ovary Syndrome

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    InvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    240 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Group 1
    Arm Type
    Experimental
    Arm Description
    PCO patients that will receive ketogenic diet only
    Arm Title
    Group 2
    Arm Type
    Experimental
    Arm Description
    PCO patients that will receive caloric diet with Metformin
    Arm Title
    Group 3
    Arm Type
    Experimental
    Arm Description
    PCO patients that will receive caloric diet only
    Intervention Type
    Behavioral
    Intervention Name(s)
    ketogenic diet
    Intervention Description
    The ketogenic diet will be designed according to the BMI for each participant by a consultant nutritionist. All participants will be prescribed this diet for 8 weeks.
    Intervention Type
    Combination Product
    Intervention Name(s)
    caloric diet with Metformin
    Intervention Description
    The caloric diet will be designed according to the BMI for each participant by a consultant nutritionist. All participants will be prescribed this diet with Metformin for 8 weeks.
    Intervention Type
    Behavioral
    Intervention Name(s)
    caloric diet
    Intervention Description
    The caloric diet will be designed according to the BMI for each participant by a consultant nutritionist. All participants will be prescribed this diet for 8 weeks.
    Primary Outcome Measure Information:
    Title
    Role of the ketogenic diet in restoring normal ovulation that will be assessed by serial transvaginal ultrasound.
    Description
    To evaluate the role of the ketogenic diet in overweight and obese women with PCOS regarding ovulation that will be assessed by serial transvaginal ultrasound.
    Time Frame
    8 weeks
    Title
    comparison between ketogenic diet, caloric diet and caloric diet with Metformin regarding ovulation that will be assessed by serial transvaginal ultrasound.
    Description
    comparison between ketogenic diet, caloric diet and caloric diet with Metformin regarding ovulation that will be assessed by serial transvaginal ultrasound.
    Time Frame
    8 weeks
    Secondary Outcome Measure Information:
    Title
    Role of the ketogenic diet in the affection of testosterone level
    Description
    To evaluate the role of the ketogenic diet in the affection of testosterone level in overweight and obese women with PCOS
    Time Frame
    8 weeks
    Title
    comparison between ketogenic diet, caloric diet and caloric diet with Metformin regarding testosterone level
    Description
    comparison between ketogenic diet, caloric diet and caloric diet with Metformin regarding testosterone level
    Time Frame
    8 weeks

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    16 Years
    Maximum Age & Unit of Time
    35 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Age range between 16-35 years. BMI ≥ 27. Normal Renal Function. Rotterdam criteria for the diagnosis of polycystic ovary syndrome: Oligo/anovulation Hyperandrogenism Polycystic ovaries on ultrasound. Exclusion Criteria: Age <16 or >35 years. BMI < 27. Pregnancy. Major medical disorders or other concurrent medical illnesses e.g. DM, other causes of androgen excess and hypercholesteremia Current or previous use of hormonal, anti-diabetic or anti-obesity drugs, or other drugs that affect hormone levels, carbohydrate metabolism or appetite.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Mazen Abdel Rasheed, PhD
    Phone
    +201111242366
    Email
    doctor_mazen@hotmail.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Amr Abbassy, MD
    Phone
    +201001446860
    Email
    abbassy2002@hotmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Amr Abbassy, MD
    Organizational Affiliation
    National Research Centre, Egypt
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    16359551
    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. doi: 10.1186/1743-7075-2-35.
    Results Reference
    background
    PubMed Identifier
    18158291
    Citation
    Palomba S, Giallauria F, Falbo A, Russo T, Oppedisano R, Tolino A, Colao A, Vigorito C, Zullo F, Orio F. Structured exercise training programme versus hypocaloric hyperproteic diet in obese polycystic ovary syndrome patients with anovulatory infertility: a 24-week pilot study. Hum Reprod. 2008 Mar;23(3):642-50. doi: 10.1093/humrep/dem391. Epub 2007 Dec 23.
    Results Reference
    background
    PubMed Identifier
    12574218
    Citation
    Moran LJ, Noakes M, Clifton PM, Tomlinson L, Galletly C, Norman RJ. Dietary composition in restoring reproductive and metabolic physiology in overweight women with polycystic ovary syndrome. J Clin Endocrinol Metab. 2003 Feb;88(2):812-9. doi: 10.1210/jc.2002-020815.
    Results Reference
    background

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    Role of the Ketogenic Diet in Women With PCOS

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