Role of the Ketogenic Diet in Women With PCOS

Polycystic Ovary Syndrome Clinical Trial

Official title:

Role of the Ketogenic Diet in Women With PCOS

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04175964
• Other study ID #: ketogenic diet in PCOS
• Status: Not yet recruiting
• Phase: N/A
• Start date: December 1, 2022
• Est. completion date: June 30, 2023

Study information

• Verified date: October 2022
• Source: National Research Centre, Egypt
• Contact: Mazen Abdel Rasheed, PhD
• Phone: +201111242366
• Email: doctor_mazen[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 240
• Est. completion date: June 30, 2023
• Est. primary completion date: April 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 16 Years to 35 Years

Eligibility

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.

Related Conditions & MeSH terms

• Polycystic Ovary Syndrome

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
National Research Centre, Egypt

References & Publications (3)

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. — View 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. — View 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. Epub 2007 Dec 23. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	8 weeks
Primary	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.	8 weeks
Secondary	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	8 weeks
Secondary	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	8 weeks