Role of the Ketogenic Diet in Women With PCOS
Palavras-chave
Resumo
Descrição
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.
datas
| Última verificação: | 04/30/2020 |
| Enviado pela primeira vez: | 11/14/2019 |
| Inscrição estimada enviada: | 11/20/2019 |
| Postado pela primeira vez: | 11/24/2019 |
| Última atualização enviada: | 05/07/2020 |
| Última atualização postada: | 05/11/2020 |
| Data real de início do estudo: | 06/30/2020 |
| Data Estimada de Conclusão Primária: | 04/29/2021 |
| Data Estimada de Conclusão do Estudo: | 06/29/2021 |
Condição ou doença
Intervenção / tratamento
Behavioral: Group 1
Combination Product: Group 2
Behavioral: Group 3
Fase
Grupos de Armas
| Braço | Intervenção / tratamento |
|---|---|
| Experimental: Group 1 PCO patients that will receive ketogenic diet only | Behavioral: Group 1 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: Group 2 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: Group 3 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. |
Critério de eleição
| Idades qualificadas para estudar | 16 Years Para 16 Years |
| Sexos elegíveis para estudo | Female |
| Aceita Voluntários Saudáveis | sim |
| Critério | 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. |
Resultado
Medidas de Resultado Primário
1. Role of the ketogenic diet in restoring normal ovulation that will be assessed by serial transvaginal ultrasound. [8 weeks]
2. comparison between ketogenic diet, caloric diet and caloric diet with Metformin regarding ovulation that will be assessed by serial transvaginal ultrasound. [8 weeks]
Medidas de Resultado Secundário
1. Role of the ketogenic diet in the affection of testosterone level [8 weeks]
2. comparison between ketogenic diet, caloric diet and caloric diet with Metformin regarding testosterone level [8 weeks]
