Role of the Ketogenic Diet in Women With PCOS

Sponsor
National Research Centre, Egypt (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04175964
Collaborator
(none)
240
3
12.9

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: ketogenic diet
  • Combination Product: caloric diet with Metformin
  • Behavioral: caloric diet
N/A

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 Design

Study Type:
Interventional
Anticipated 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
Anticipated Study Start Date :
Jun 1, 2022
Anticipated Primary Completion Date :
Apr 30, 2023
Anticipated Study Completion Date :
Jun 30, 2023

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Role of the ketogenic diet in restoring normal ovulation that will be assessed by serial transvaginal ultrasound. [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. [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 [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 [8 weeks]

    comparison between ketogenic diet, caloric diet and caloric diet with Metformin regarding testosterone level

Eligibility Criteria

Criteria

Ages Eligible for Study:
16 Years to 35 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • National Research Centre, Egypt

Investigators

  • Study Director: Amr Abbassy, MD, National research centre

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Mazen Abdel Rasheed, Researcher, Principal Investigator, National Research Centre, Egypt
ClinicalTrials.gov Identifier:
NCT04175964
Other Study ID Numbers:
  • ketogenic diet in PCOS
First Posted:
Nov 25, 2019
Last Update Posted:
Jan 12, 2022
Last Verified:
Jan 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 12, 2022