Short Term Ketogenic Diet in Polycictic Ovary Syndrome
NCT Number: NCT06469255
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Polycystic Ovary Syndrome
Interventions: OTHER: Diet Treatment
Sponsor: Istanbul Bilgi University
Sex: FEMALE
Age: ADULT
Enrollment: 13
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2019-10-01
Completion Date: 2020-03-30
Locations: İstanbul Bilgi University, İstanbul, 34060, Turkey

Summary:
Polycystic ovary syndrome (PCOS) is one of the most common health problems in women of reproductive age, characterized by increased androgen levels, impaired ovulatory functions, and polycystic ovaries. In addition to cosmetic problems including hirsutism and acne, it also poses a risk for significant chronic diseases, including infertility, dyslipidemia, obesity, sleep apnea, diabetes, cardiovascular diseases, and various malignancies.

The aim of this clinical study was to investigate the effects of short-term low-calorie ketogenic diet (LCKD) intervention on anthropometric, biochemical and hormonal parameters in women with PCOS. The main questions it aims to answer are:

* Is a short-term low-calorie ketogenic diet effective on body composition in overweight women with PCOS?
* Is a short-term low-calorie ketogenic diet effective on biochemical and hormonal parameters in overweight women with PCOS?

Participants were diagnosed with PCOS according to the Rotterdam 2003 criteria as a result of the clinical, biochemical and ultrasonographic medical evaluation made by the gynecologist, and those who were found to be eligible for LCKD and volunteered to participate in the study were included in the study.

Researchers are examining whether a low-calorie ketogenic diet applied between two menstrual cycles has any effects on anthropometric, biochemical and hormonal parameters in women with PCOS.

Primary Outcome Measures: Anthropometric Measurements - Body weight and composition, Body weight (kg) of the participants were measured in light clothing on an empty stomach, following anthropometric measurement standards (Norton, 2018). Total body weight and body composition analysis (fat ratio, fat, muscle, fluid mass, and phase angle \[PhA\]) were performed following the protocol using the TANİTA MC780 MA bio-electrical impedance device with a sensitivity of 50 grams., 4 weeks (Between two menstrual cycle)|Anthropometric Measurements - Height, Height (cm) measurements of the participants were measured following anthropometric measurement standards with stadiometer (Norton, 2018)., 4 weeks (Between two menstrual cycle)|Anthropometric Measurements - Circumferences, Waist, hip, neck, upper middle arm, and chest circumference measurements of the participants were measured in light clothing on an empty stomach, following anthropometric measurement standards (Norton, 2018)., 4 weeks (Between two menstrual cycle)|Body Mass Index, Body mass index (BMI) (kg/m2) was calculated using the following equation: body weight (kg)/height (m2) (Misra \& Dhurandhar, 2019)., 4 weeks (Between two menstrual cycle)|Biochemical Measurements, This study was conducted between two menstrual cycles to accurately determine baseline and ending basal hormone levels, and biochemical parameters were measured by blood collection on the second to third day of menstruation. On the following days, a nurse extracted blood samples following an 8-12-h fasting. Subsequently, the blood samples were examined for fasting insulin, fasting blood glucose, total cholesterol, triglyceride, HDL-cholesterol, LDL-cholesterol, DHEA-SO4, androstenedione, LH, FSH, estradiol, SHBG, total testosterone, prolactin, IGF-1, and TNF-α levels. HOMA-IR, which was developed by Mathews et al., was used to determine insulin resistance using fasting glucose and insulin levels. It is calculated using the following formula: HOMA-IR = (fasting glucose \[mg/dL\] × fasting insulin \[uIU/mL\])/405 (Matthews et al., 1985)., 4 weeks (Between two menstrual cycle)
Secondary Outcome Measures: Food Consumption Evaluation, Participants' food consumption before the dietary intervention was recorded using the 24-h reminder method (2 days on weekdays and 1 day on the weekend). Intakes of macro- and micronutrients such as energy, carbohydrates, proteins, and fats were evaluated using the Nutrition Information System (BeBİS) 8.2 full version program (BeBİS, 2019)., 1 times before intervention