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Trial registered on ANZCTR


Registration number
ACTRN12621000994886
Ethics application status
Approved
Date submitted
7/06/2021
Date registered
28/07/2021
Date last updated
28/07/2021
Date data sharing statement initially provided
28/07/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
The effectiveness of a Mediterranean diet on hormonal, metabolic and body composition in overweight and obese women with Polycystic Ovary Syndrome.
Scientific title
Efficacy of a Mediterranean diet on hormonal, metabolic and body composition in overweight and obese women with Polycystic Ovary Syndrome
Secondary ID [1] 304134 0
Nil known
Universal Trial Number (UTN)
Trial acronym
MedPCOS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Polycystic Ovary Syndrome 321823 0
Condition category
Condition code
Metabolic and Endocrine 319556 319556 0 0
Other endocrine disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.

Intervention code [1] 320472 0
Lifestyle
Intervention code [2] 320764 0
Behaviour
Comparator / control treatment
The control diet will be a 12-week, individualized and prescribed low-fat dietary intervention. The Low-fat diet group will be asked to consume a diet consistent with the Australian Dietary Guidelines and Australian Guide to Healthy Eating. This will include a dietary pattern consisting of wholegrain breads and cereals, vegetables, fruit, low-fat dairy, lean meat, poultry and fish and smaller servings of unsaturated fats.

Participants will receive 7 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 outcomes, counselling and education on dietary protocol and a set of resources.
*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 each fortnight and 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.

To facilitate dietary adherence, all participants will receive a provision of 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).

Participants will be required to maintain their usual physical activity behaviour throughout the 12-week intervention.
Control group
Active

Outcomes
Primary outcome [1] 327423 0
Change in serum concentration of insulin (homeostatic model assessment (HOMA)) using 12-hour fasting blood test.
Timepoint [1] 327423 0
Baseline and week 12 (post intervention)
Primary outcome [2] 327775 0
Change in serum concentrations of total testosterone and sex hormone binding globulin (composite outcome) using 12-hour fasting blood test.
Timepoint [2] 327775 0
Baseline and week 12 (post-intervention)
Primary outcome [3] 328225 0
Change in fasting blood glucose concentrations (12-hour fasting blood test)
Timepoint [3] 328225 0
Baseline and post-intervention (week 12)
Secondary outcome [1] 395095 0
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,
Timepoint [1] 395095 0
Change in body mass: Baseline, weeks 2, 4, 6, 8, 10, 12 (post intervention)
Secondary outcome [2] 398175 0
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.
Timepoint [2] 398175 0
Baseline and post-intervention (week 12)
Secondary outcome [3] 398177 0
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.
Timepoint [3] 398177 0
Baseline and post-intervention (week 12)
Secondary outcome [4] 398178 0
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.
Timepoint [4] 398178 0
Baseline and post-intervention (week 12)
Secondary outcome [5] 398179 0
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.
Timepoint [5] 398179 0
Baseline, week 6 and week 12 (post intervention)
Secondary outcome [6] 398180 0
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.
Timepoint [6] 398180 0
Baseline and post-intervention (week 12)

Eligibility
Key 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
Minimum age
18 Years
Maximum age
45 Years
Gender
Females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
External off-site investigator
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Volunteers will be randomly assigned to either group (intervention or control) following the completion of all baseline measures using a random number, computer generated randomisation schedule.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
The required sample size is powered based on change in Homeostatic Model Assessment of Insulin Resistance (HOMA-IR). It was estimated that a total of n = 32 participants would provide 80% power to detect a significant (P less than 0.05, 2-sided) change in HOMA-IR by 1.7 +/-0.5. Assuming an attrition rate of 30%, the target sample size for the proposed study will be n=42 participants (MedDiet intervention n =21; Low-fat intervention n = 21).

All continuous variables will be presented as mean (+/- SD) or median (IQR) with categorical variables presented as frequencies or percentages. Paired t-tests will be used to identify whether outcome measures change over time. After adjusting for covariates, analysis of covariance (ANCOVA) will be applied to identify differences between groups over time, with diet groups as the independent variable and outcome parameters as the dependent variable.
Semi-structured interviews will be audio-recorded and transcribed verbatim and analysed using an inductive thematic approach. Following this, a coding framework will be used by the research team and applied to transcripts. Related codes will be subsequently grouped into themes.



Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 308512 0
Government body
Name [1] 308512 0
NHMRC Centre for Research Excellence in Women's Health in Reproductive Life
Address [1] 308512 0
16 Marcus Clarke Street, Canberra ACT 2601
Country [1] 308512 0
Australia
Funding source category [2] 308519 0
University
Name [2] 308519 0
Monash University
Address [2] 308519 0
Wellington Road, Clayton, Victoria 3800
Country [2] 308519 0
Australia
Primary sponsor type
Individual
Name
Dr Anthony Villani
Address
University of the Sunshine Coast; School of Health and Behavioural Sciences; 90 Sippy Downs Drive, Sippy Downs, QLD 4556
Country
Australia
Secondary sponsor category [1] 309373 0
University
Name [1] 309373 0
University of the Sunshine Coast
Address [1] 309373 0
90 Sippy Downs Drive, Sippy Downs QLD 4556
Country [1] 309373 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308470 0
University of the Sunshine Coast Human Research Ethics Committee
Ethics committee address [1] 308470 0
90 Sippy Downs Drive, Sippy Downs QLD 4556
Ethics committee country [1] 308470 0
Australia
Date submitted for ethics approval [1] 308470 0
23/02/2021
Approval date [1] 308470 0
11/05/2021
Ethics approval number [1] 308470 0
A211524

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 110802 0
Dr Anthony Villani
Address 110802 0
University of the Sunshine Coast
90 Sippy Downs Drive, Sippy Downs QLD 4556
Country 110802 0
Australia
Phone 110802 0
+61 7 5456 3546
Fax 110802 0
Email 110802 0
avillani@usc.edu.au
Contact person for public queries
Name 110803 0
Dr Anthony Villani
Address 110803 0
University of the Sunshine Coast
90 Sippy Downs Drive, Sippy Downs QLD 4556
Country 110803 0
Australia
Phone 110803 0
+61 7 5456 3546
Fax 110803 0
Email 110803 0
avillani@usc.edu.au
Contact person for scientific queries
Name 110804 0
Dr Anthony Villani
Address 110804 0
University of the Sunshine Coast
90 Sippy Downs Drive, Sippy Downs QLD 4556
Country 110804 0
Australia
Phone 110804 0
+61 7 5456 3546
Fax 110804 0
Email 110804 0
avillani@usc.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Primary or secondary data from this project will not be made available for other researchers or secondary parties to access at any time, unless required by law. All data will be stored for at least five years after completion of the project or any publication derived from it. Preliminary data may also be used for the purposes of applying for competitive grant funding.
What supporting documents are/will be available?
No other documents available
Summary results
No Results