Clinical trial NCT04175964: Role of the Ketogenic Diet in Women With PCOS
Official title: Role of the Ketogenic Diet in Women With PCOS
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Polycystic Ovary Syndrome
Lead sponsor: National Research Centre, Egypt
Sponsor class: OTHER
First posted: 2019-11-25
Enrollment: 240
Sex: FEMALE
Minimum age (years): 16
Maximum age (years): 35
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Role of the ketogenic diet in restoring normal ovulation that will be assessed by serial transvaginal ultrasound.
timeFrame: 8 weeks
measure: comparison between ketogenic diet, caloric diet and caloric diet with Metformin regarding ovulation that will be assessed by serial transvaginal ultrasound.
timeFrame: 8 weeks
Secondary outcomes:
measure: Role of the ketogenic diet in the affection of testosterone level
timeFrame: 8 weeks
measure: comparison between ketogenic diet, caloric diet and caloric diet with Metformin regarding testosterone level
timeFrame: 8 weeks
Other outcomes:
Locations:
Study officials:
affiliation: National Research Centre, Egypt
name: Amr Abbassy, MD
role: STUDY_DIRECTOR
References:
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.
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.
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.