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Role of the Ketogenic Diet in Women With PCOS

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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

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.

Condition or disease Intervention/treatment Phase
Polycystic Ovary Syndrome Behavioral: ketogenic diet Combination Product: caloric diet with Metformin Behavioral: caloric diet Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Role of the Ketogenic Diet in Women With PCOS
Estimated Study Start Date : January 1, 2020
Estimated Primary Completion Date : October 31, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Group 1
PCO patients that will receive ketogenic diet only
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.

Experimental: Group 2
PCO patients that will receive caloric diet with Metformin
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.

Experimental: Group 3
PCO patients that will receive caloric diet only
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.




Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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

  2. 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



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Ages Eligible for Study:   16 Years to 35 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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.

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): NCT04175964


Contacts
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Contact: Mazen Abdel Rasheed, PhD +201111242366 doctor_mazen@hotmail.com
Contact: Amr Abbassy, MD +201001446860 abbassy2002@hotmail.com

Sponsors and Collaborators
National Research Center, Egypt
Investigators
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Study Director: Amr Abbassy, MD National research centre

Publications:
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Responsible Party: Mazen Abdel Rasheed, Researcher, Principal Investigator, National Research Center, Egypt
ClinicalTrials.gov Identifier: NCT04175964     History of Changes
Other Study ID Numbers: ketogenic diet in PCOS
First Posted: November 25, 2019    Key Record Dates
Last Update Posted: November 25, 2019
Last Verified: November 2019

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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
Ovarian Cysts
Cysts
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs