Role of the Ketogenic Diet in Women With PCOS

National Research Centre, Egypt

Status: Not yet enrolling

Conditions: Polycystic Ovary Syndrome

Treatments: Combination Product: caloric diet with Metformin; Behavioral: caloric diet; Behavioral: ketogenic diet

Study type: Interventional

Funder types: Other

Identifiers

NCT04175964

ketogenic diet in PCOS

Details and patient eligibility

About

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.

Full 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.

Enrollment: 240 estimated patients

Sex: Female

Ages: 16 to 35 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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240 participants in 3 patient groups

Group 1

Experimental group

Description:

PCO patients that will receive ketogenic diet only

Treatment:

Behavioral: ketogenic diet

Group 2

Experimental group

Description:

PCO patients that will receive caloric diet with Metformin

Treatment:

Combination Product: caloric diet with Metformin

Group 3

Experimental group

Description:

PCO patients that will receive caloric diet only

Treatment:

Behavioral: caloric diet