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
About this trial
This is an interventional supportive care trial for Polycystic Ovary Syndrome
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.
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
NCT ID
NCT04175964
First Posted
November 15, 2019
Last Updated
October 2, 2022
Sponsor
National Research Centre, Egypt
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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