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.
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)
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
Parallel
Synbiotic Supplement
Dietary supplementParticipants in this arm will receive a hypocaloric Mediterranean diet in addition to synbiotic supplementation for a period of 8 weeks.
Placebo
Other interventionParticipants in this arm will receive a hypocaloric Mediterranean diet in addition to a placebo for a period of 8 weeks.
Change in body weight
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)
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
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
Changes in waist circumference measured in centimeters using a non-elastic measuring tape at baseline and after the 8-week intervention.
Change in insulin resistance (HOMA-IR)
Changes in insulin resistance assessed using the Homeostatic Model Assessment of Insulin Resistance (HOMA-IR), calculated from fasting plasma glucose and fasting insulin levels. A HOMA-IR value below 2.5 will be considered indicative of the absence of insulin resistance. Measurements will be performed at baseline and after the 8-week intervention.
Change in fasting blood glucose
Changes in fasting blood glucose levels measured in mg/dL from venous blood samples collected at baseline and after the 8-week intervention.
Change in lipid profile
Changes in serum lipid profile parameters, including high-density lipoprotein cholesterol (HDL-C), low-density lipoprotein cholesterol (LDL-C), triglycerides (TG), and total cholesterol, measured in mg/dL from venous blood samples collected at baseline and after the 8-week intervention.
Change in follicle-stimulating hormone (FSH) levels
Changes in serum follicle-stimulating hormone (FSH) levels measured from venous blood samples collected at baseline and after the 8-week intervention.
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options:
