The effectiveness of a Mediterranean diet on hormonal, metabolic and body composition in overweight and obese women with Polycystic Ovary Syndrome.

INTERVENTION: Participants will be randomly allocated one of two prescribed and individualised 12‐week dietary interventions. The Mediterranean diet (MedDiet) group will be asked to consume a diet consistent with a traditional Mediterranean Diet including: 1–4 tablespoons of extra virgin olive oil/day 5–6 serves of vegetables/day 2–3 serves of fruit/day 4–6 serves of wholegrains/day up to 200ml red wine/day 3 serves of legumes/wk 3 serves of nuts/wk 3 serves of Greek yoghurt/wk 2‐3 servings of eggs/wk 2‐3 serves of fish and seafood/wk 1–3 servings of poultry/wk up to 1 serve of red meat/wk Participants will receive fortnightly face to face consultations with an Accredited Practising Dietitian at a consultation room at the University of the Sunshine Coast. Consultations will consist of: *Baseline lasting 60‐90mins to include assessment of outcome measures, counselling and education on the dietary protocol and a set of educational resources to facilitate dietary compliance *Five fortnightly consults at weeks 2, 4, 6, 8 and 10 lasting 30mins to include dietary counselling, education and monitoring of body mass. *Final lasting 60‐90mins to include assessment of outcomes. Participants will complete a daily dietary checklist consistent with the dietary protocol and return the checklist each fortnight. Participants will also complete a 4‐day food diary at baseline, week 6 and week 12. These will be used to facilitate discussion and education during the Dietetic consultations. In each of the five fortnightly consults, all participants (irrespective of the treatment allocation) will receive individual counselling and education by an Accredited Practising Dietitian. As such, part of this process will also involve the provisi CONDITION: Metabolic and Endocrine ‐ Other endocrine disorders Polycystic Ovary Syndrome; ; Polycystic Ovary Syndrome PRIMARY OUTCOME: Change in fasting blood glucose concentrations (12‐hour fasting blood test)[Baseline and post‐intervention (week 12)] Change in serum concentration of insulin (homeostatic model assessment (HOMA)) using 12‐hour fasting blood test.[Baseline and week 12 (post intervention)] Change in serum concentrations of total testosterone and sex hormone binding globulin (composite outcome) using 12‐hour fasting blood test.[Baseline and week 12 (post‐intervention)] INCLUSION CRITERIA: 1. Confirmed diagnosis of Polycystic Ovary Syndrome according to the Rotterdam criteria which is based on participants presenting with two of the three following criteria including: 1) menstrual irregularity (infrequent menstrual periods) and/or anovulation; 2) clinical and/or biochemical hyperandrogenism; 3) polycystic ovaries based on ultrasound examination. 2. Body mass index of 25kg/m2 or more SECONDARY OUTCOME: Adherence to a Mediterranean diet. This will will be assessed using the previously validated 14‐item MEDAS, used in the Prevención con Dieta Mediterránea (PREDIMED) study. The MEDAS determines adherence scores according to pre‐defined normative criterion cut‐off points for the habitual frequency of consumption or amount consumed (pre‐defined servings/day or servings/week) of 12 main dietary elements and two food habits related to a traditional MedDiet pattern. The 14 questions in the questionnaire will each be scored a 0 or 1, generating a maximum score of 14. Specifically, a MEDAS score greater than 10 suggests high adherence, scores between 6 and 9 indicate moderate adherence, and a score less than 5 is considered low adherence.[Baseline and post‐intervention (week 12)] Change in body mass (kg). A calibrated digital scale (AND Weighing; HW‐KGL, Melbourne, Australia) will be used to record body mass to the nearest 0.1 kg,[Change in body mass: Baseline, weeks 2, 4, 6, 8, 10, 12 (post intervention)] Change in waist circumference. This measure will be performed by trained research personnel and measured to the nearest 0.1 cm using a flexible steel tape measure (Lufkin Executive Thinline) at the point midway between the iliac crest and the lower costal border (lower rib) according to standardized protocols. This will be measured on three separate occasions with the mean of the three measures used for final analyses.[Baseline and post‐intervention (week 12)] Dietary intake. this will be assessed using a 4‐day food record.Participants will be asked to record all food and beverage intake for a period of 4‐days (3 weekdays and 1 weekend day) using standard household utensils such as cup/teaspoon and tablespoon measures before sending the food record back to the investigators using the return paid envelope provided. All food records will be entered into Foodworks by a member of the research team for a comprehensive nutrient analysis assessment using food composition data derived from two Australian databases, AUSNUT 2007 and NUTTAB 2010. [Baseline, week 6 and week 12 (post intervention)] Feasibility to the MedDiet intervention. Participants randomized to the MedDiet intervention will complete an individual semi‐structured interview and complete a series of Likert scales to assess their opinion of the acceptability of the study resources and their confidence in their ability to follow a MedDiet. [Baseline and post‐intervention (week 12)] Physical activity status. This will be monitored using the short version of the International Physical Activity Questionnaire (IPAQ‐SF). IPA‐SF quantifies physical activity during the previous seven days and is divided into four categories: vigorous intensity, moderate intensity, walking and sedentary behaviour. Furthermore, intensity, frequency and duration of physical activity are also assessed.[Baseline and post‐intervention (week 12)]