Role of the Ketogenic Diet in Women With PCOS
- Conditions
- Polycystic Ovary Syndrome
- Interventions
- Combination Product: caloric diet with MetforminBehavioral: ketogenic dietBehavioral: caloric diet
- Registration Number
- NCT04175964
- Lead Sponsor
- National Research Centre, 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.
- 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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- Female
- Target Recruitment
- 240
-
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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group 2 caloric diet with Metformin PCO patients that will receive caloric diet with Metformin Group 1 ketogenic diet PCO patients that will receive ketogenic diet only Group 3 caloric diet PCO patients that will receive caloric diet only
- Primary Outcome Measures
Name Time Method 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.
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
Name Time Method 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
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