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Role of the Ketogenic Diet in Women With PCOS

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04175964
Recruitment Status : Not yet recruiting
First Posted : November 25, 2019
Last Update Posted : November 25, 2019
Sponsor:
Information provided by (Responsible Party):
Mazen Abdel Rasheed, National Research Center, Egypt

Tracking Information
First Submitted Date  ICMJE November 15, 2019
First Posted Date  ICMJE November 25, 2019
Last Update Posted Date November 25, 2019
Estimated Study Start Date  ICMJE January 1, 2020
Estimated Primary Completion Date October 31, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 21, 2019)
  • Role of the ketogenic diet in restoring normal ovulation that will be assessed by serial transvaginal ultrasound. [ Time Frame: 8 weeks ]
    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. [ Time Frame: 8 weeks ]
    comparison between ketogenic diet, caloric diet and caloric diet with Metformin regarding ovulation that will be assessed by serial transvaginal ultrasound.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: November 21, 2019)
  • Role of the ketogenic diet in the affection of testosterone level [ Time Frame: 8 weeks ]
    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 [ Time Frame: 8 weeks ]
    comparison between ketogenic diet, caloric diet and caloric diet with Metformin regarding testosterone level
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 Role of the Ketogenic Diet in Women With PCOS
Official Title  ICMJE Role of the Ketogenic Diet in Women With PCOS
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Condition  ICMJE Polycystic Ovary Syndrome
Intervention  ICMJE
  • Behavioral: ketogenic diet
    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.
  • Combination Product: caloric diet with Metformin
    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.
  • Behavioral: caloric diet
    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.
Study Arms  ICMJE
  • Experimental: Group 1
    PCO patients that will receive ketogenic diet only
    Intervention: Behavioral: ketogenic diet
  • Experimental: Group 2
    PCO patients that will receive caloric diet with Metformin
    Intervention: Combination Product: caloric diet with Metformin
  • Experimental: Group 3
    PCO patients that will receive caloric diet only
    Intervention: Behavioral: caloric diet
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 Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: November 21, 2019)
240
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2020
Estimated Primary Completion Date October 31, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 16 Years to 35 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Mazen Abdel Rasheed, PhD +201111242366 doctor_mazen@hotmail.com
Contact: Amr Abbassy, MD +201001446860 abbassy2002@hotmail.com
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04175964
Other Study ID Numbers  ICMJE ketogenic diet in PCOS
Has Data Monitoring Committee Not Provided
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 Not Provided
Responsible Party Mazen Abdel Rasheed, National Research Center, Egypt
Study Sponsor  ICMJE National Research Center, Egypt
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Amr Abbassy, MD National research centre
PRS Account National Research Center, Egypt
Verification Date November 2019

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