Effects of a Mediterranean Diet and Synbiotic Supplementation on Anthropometric and Biochemical Parameters and Quality of Life in Obese Women With Polycystic Ovary Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 32
- 主要终点
- Change in body weight
研究概览
简要总结
This study will look at whether a reduced-calorie Mediterranean-style eating plan, together with a synbiotic supplement, can improve health measures and quality of life in women who have polycystic ovary syndrome (PCOS) and are overweight or have obesity. Participants will be assigned by chance (like flipping a coin) to receive either the synbiotic supplement or a placebo (a look-alike product with no active ingredients). All participants will follow the same reduced-calorie Mediterranean diet for 8 weeks. The study team will measure body composition and weight-related measurements, and will collect blood samples to evaluate selected laboratory markers before and after the 8-week period. Participants will also complete the PCOSQ-50 quality-of-life questionnaire before and after the intervention. The goal is to better understand the possible role of synbiotic supplementation alongside dietary treatment in PCOS.
详细描述
This randomized, placebo-controlled, single-blind clinical trial is designed to evaluate the effects of a hypocaloric Mediterranean diet combined with synbiotic supplementation on anthropometric measurements, biochemical parameters, and quality of life in overweight and obese women diagnosed with polycystic ovary syndrome (PCOS). Eligible participants will be randomly assigned to one of two study arms: a synbiotic supplementation group or a placebo group. Both groups will follow the same hypocaloric Mediterranean diet throughout the 8-week intervention period.
Anthropometric assessments, including body weight, body mass index, waist circumference, and body composition, will be performed at baseline and at the end of the intervention. Biochemical parameters will be evaluated through blood samples collected at baseline and after 8 weeks. Quality of life will be assessed using the PCOSQ-50 Quality of Life Questionnaire at both time points.
The study aims to determine whether the addition of synbiotic supplementation to a hypocaloric Mediterranean diet provides additional benefits in the management of PCOS-related metabolic parameters and quality of life compared with dietary intervention alone.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Premenopausal women who are overweight or obese, with a body mass index (BMI) between 25 and 35 kg/m²
- •Aged 18 to 45 years (reproductive age)
- •Diagnosed with polycystic ovary syndrome (PCOS)
- •No underlying metabolic diseases, including type 2 diabetes mellitus, hypertension, diagnosed anemia, or any other metabolic condition requiring a special diet
排除标准
- •Pregnancy or breastfeeding within the past 6 months
- •Presence of comorbid conditions, including kidney, liver, or cardiovascular disease, gout, hyperuricemia, or other related disorders
- •Use of oral contraceptives
- •Following a special dietary treatment or a hypocaloric diet within the last 3 months
- •Occasional or current use of medications that may affect fluid balance, including diuretics and laxatives
- •Participants will be withdrawn from the study in case of abnormal biochemical parameters, non-adherence to the prescribed diet, or failure to comply with the supplementation protoco
结局指标
主要结局
Change in body weight
时间窗: From enrollment to the end of treatment at 8 weeks
Changes in body weight measured in kilograms using the Tanita MC-780 bioelectrical impedance analysis (BIA) device at baseline and after the 8-week intervention.
Change in body mass index (BMI)
时间窗: From enrollment to the end of treatment at 8 weeks
Changes in body mass index (BMI), calculated as weight in kilograms divided by height in meters squared (kg/m²), with body weight measured using the Tanita MC-780 bioelectrical impedance analysis (BIA) device at baseline and after the 8-week intervention.
Change in body composition
时间窗: From enrollment to the end of treatment at 8 weeks
Changes in body composition parameters, including fat mass and fat-free mass, assessed using the Tanita MC-780 bioelectrical impedance analysis (BIA) device at baseline and after the 8-week intervention.
Change in waist circumference
时间窗: From enrollment to the end of treatment at 8 weeks
Changes in waist circumference measured in centimeters using a non-elastic measuring tape at baseline and after the 8-week intervention.
Change in hip circumference
时间窗: From enrollment to the end of treatment at 8 weeks
Changes in hip circumference measured in centimeters using a non-elastic measuring tape at baseline and after the 8-week intervention.
次要结局
- Change in insulin resistance (HOMA-IR)(From enrollment to the end of treatment at 8 weeks)
- Change in fasting blood glucose(From enrollment to the end of treatment at 8 weeks)
- Change in lipid profile(From enrollment to the end of treatment at 8 weeks)
- Change in follicle-stimulating hormone (FSH) levels(From enrollment to the end of treatment at 8 weeks)
- Change in luteinizing hormone (LH) levels(From enrollment to the end of treatment at 8 weeks)
- Change in quality of life(From enrollment to the end of treatment at 8 weeks)
研究者
Aysenur Emirhuseyinoglu Calik
Research Assistant
Atlas University