None listed
Conditions
Brief summary
The purpose of this research project is to investigate the effectiveness of a Mediterranean diet on hormonal, metabolic, body weight and body composition without the need to reduce total calorie intake in overweight and obese women with diagnosed Polycystic Ovary Syndrome. This will be compared against a standard low-fat diet that is aligned with the Australian Dietary Guidelines. We are also interested in finding out participants' opinions on the Mediterranean diet and how well it can be followed. The Mediterranean diet is a type of dietary pattern high in vegetables, legumes, fruit, wholegrains and extra-virgin olive oil; moderate in nuts and seeds, fermented dairy, eggs, fish and seafood and red wine. We know that insulin resistance and risk for type 2 diabetes is a common metabolic consequence in reproductive-aged women with Polycystic Ovary Syndrome. In addition, many women with Polycystic Ovary Syndrome also have difficulty achieving a healthy weight, which further worsens insulin resistance. The current guidelines for the management of Polycystic Ovary Syndrome emphasise achieving and maintaining a healthy weight and lifestyle (diet and physical activity). However, there is no high-quality evidence supporting specific dietary recommendations for reproductive-aged women with Polycystic Ovary Syndrome. The Mediterranean diet is a type of dietary pattern consistent with good health and has shown to be effective at improving insulin resistance, even without the need to reduce total calories. Therefore, this study will provide a valuable contribution to the scientific knowledge in this field.
Interventions
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 ser
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 provision of patient-centered counselling/education and the provision of resources on how principles of each intervention can be incorporated into the participants lifestyle and routine. As such, recommended servings of key food groups will be adjusted according to estimated energy requirements and participant dietary preferences, whilst still maintaining a nutrient profile that is consistent/aligned with the MedDiet (intervention) or standard low-fat diet (control). To facilitate dietary adherence, all participants will receive educational resources which will include meal plans and recipes in the form of a ‘cookbook’, shopping lists, label reading resources, recommended daily/weekly servings of core food groups, online education resources and weekly (x 12 in total) text messages in the form of ‘healthy’ nudges to facilitate dietary compliance. For participants without online access, this will be presented as a physical resource (e.g. hard copy format). All educational resources for this trial were developed by members of the research team, specifically for use by women diagnosed with PCOS; this process also involved considerable consumer feedback in the development and design of educational resources through our stakeholder advisory committee. Participants will be required to maintain their usual physical activity behaviour throughout the 12-week intervention.
Sponsors
Dr Anthony Villani
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Healthy volunteers
No
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
Exclusion criteria
Participants will be excluded based on the following criteria: Pregnancy Type 2 diabetes Current use of hormonal contraceptives or insulin sensitizing drugs High adherence to a MedDiet defined as a score >10 using the 14-item Mediterranean diet adherence screener (MEDAS) Cushing's syndrome Hypothyroidism Androgen tumors Active cancer
Outcome results
None listed