Inositol and Metformin Administration in Mediterranean Diet and Low-Carbohydrate Diets in Women With PCOS
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age20-40
SponsorDicle University
About this trial
Polycystic ovary syndrome (PCOS) is a common endocrine disorder frequently associated with obesity, insulin resistance (IR), and metabolic dysfunction. Although lifestyle modification is recommended as first-line therapy, the optimal dietary approach for women with PCOS remains uncertain. This randomized, controlled, open-label, parallel-group trial aims to compare the effects of a Mediterranean diet (MD) and a low-carbohydrate diet (LCD), each combined with metformin, inositol, or folic acid (active control), in obese women with PCOS and IR. A total of 102 participants will be randomly assigned to one of six intervention groups and followed for two months. Anthropometric measurements, body composition, biochemical parameters, and hedonic hunger will be assessed at baseline and after the intervention. The primary outcome is the change in insulin resistance, assessed by the Homeostatic Model Assessment for Insulin Resistance (HOMA-IR), from baseline to 2 months. Secondary outcomes include changes in body composition, metabolic and biochemical parameters, and hedonic hunger.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Women aged 20-40
Diagnosed with PCOS (Rotterdam, 2004)
Insulin resistant (newly diagnosed or diagnosed within the last 3 months)
Obese according to the World Health Organization (2006) in grades 1 and 2 (BMI: 30-40 kg/m²)
Disqualifiers
Pregnant or breastfeeding women
Those undergoing/contemplating IVF treatment
Early menopause diagnosis
Diabetes diagnosis, use of oral antidiabetic agents
Trial design
Design model
Parallel
Treatments tested in this trial
Metformin
DrugMetformin will be administered orally for 2 months. Treatment will begin at 500 mg once daily during the first week and will be increased to 1000 mg/day (500 mg twice daily) from the second week onward, as tolerated. Dose escalation is intended to improve gastrointestinal tolerability while achieving the target maintenance dose.
İnositol
Dietary supplementMyo-inositol will be administered orally as a powdered sachet formulation. Participants will receive two sachets daily for 2 months, providing a total daily dose of 4000 mg myo-inositol and 400 µg folic acid.
Folic Acid
Dietary supplementFolic acid will be administered orally at a dose of 400 µg once daily for 2 months. Folic acid is provided to participants in the metformin and control groups to standardize folate intake across intervention groups, as the myo-inositol supplement administered in the inositol groups also contains 400 µg of folic acid per day.
Mediterranean diet
Other interventionParticipants will receive individualized hypocaloric Mediterranean diet counseling for 2 months. Daily energy requirements will be calculated individually, and meal plans will be prescribed with an energy deficit of approximately 500 kcal/day to promote weight loss. The dietary pattern will emphasize vegetables, fruits, whole grains, legumes, nuts, olive oil as the principal source of fat, moderate consumption of fish, poultry, and low-fat dairy products, and limited consumption of red and processed meat, refined grains, and foods high in added sugars and saturated fat. Dietary adherence will be monitored at regular follow-up visits throughout the intervention period.
Low-Carbohydrate Diet
Other interventionParticipants will receive individualized hypocaloric low-carbohydrate diet counseling for 2 months. Daily energy requirements will be calculated individually, and meal plans will be prescribed with an energy deficit of approximately 500 kcal/day to promote weight loss. The diet will provide 50-130 g/day of carbohydrates or approximately 25-30% of total daily energy from carbohydrates. After achieving the carbohydrate target, the remaining energy intake will be distributed to provide approximately 15-30% of total energy from protein and 35-50% from fat, according to individual energy requirements. Dietary adherence will be monitored at regular follow-up visits throughout the intervention period.
Treatment groups
90 Participants
are divided into 6 treatment groups6
Treatment groupsSee each treatment group below.
Group A: Group Receiving Mediterranean Diet and Inositol SupplementExperimental treatment 2 interventions
Group B: Group Receiving Mediterranean Diet and Metformin TreatmentExperimental treatment 3 interventions
Group C: Mediterranean Diet Active Control GroupActive comparator 2 interventions
Group D: Group Receiving Low-Carbohydrate Diet and Inositol SupplementExperimental treatment 2 interventions
Group E: Group Receiving Low-Carbohydrate Diet and Metformin TreatmentExperimental treatment 3 interventions
Group F: Low-Carbohydrate Diet Active Control GroupActive comparator 2 interventions
Trial outcomes
Primary outcomes
1
Change in Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) from Baseline to 2 Months
Insulin resistance will be assessed using the Homeostatic Model Assessment for Insulin Resistance (HOMA-IR), calculated from fasting plasma glucose and fasting serum insulin concentrations. The primary outcome will be the change in HOMA-IR from baseline to 2 months. Lower HOMA-IR values indicate improved insulin sensitivity.
Time frame
Baseline and 2 monthsSecondary outcomes
1
Change in Body Weight From Baseline to 2 Months
Body weight will be measured in kilograms (kg). Change in body weight will be calculated as the value at 2 months minus the baseline value.
Time frame
Baseline and 2 months2
Change in Body Mass Index From Baseline to 2 Months
Body mass index (BMI) will be calculated as body weight in kilograms divided by height in meters squared (kg/m²). Change in BMI will be calculated as the value at 2 months minus the baseline value.
Time frame
Baseline and 2 months3
Change in Body Fat Percentage From Baseline to 2 Months
Body fat percentage will be assessed by bioelectrical impedance analysis (BIA) and reported as a percentage (%). Change in body fat percentage will be calculated as the value at 2 months minus the baseline value.
Time frame
Baseline to 2 Months4
Change in Body Fat Mass From Baseline to 2 Months
Body fat mass will be assessed by bioelectrical impedance analysis (BIA) and reported in kilograms (kg). Change in body fat mass will be calculated as the value at 2 months minus the baseline value.
Time frame
Baseline to 2 MonthsSponsors and contacts
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Source ClinicalTrials.gov
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