VOLUNTEERS WANTED FOR CLINICAL TRIAL: Examining the effects of the Mediterranean diet on Type 2 Diabetes

Clinical Trial TYPE 2 Dibetic

Researchers at RMIT University in Australia, are seeking volunteer research participants to be involved in a study about the management of type 2 diabetes through an alternative dietary plan based on the Mediterranean diet.

Through the clinical trial scientists hope to learn whether a Mediterranean dietary pattern with or without intermittent fasting may better control diabetes, as compared with a conventional diet based on the current recommendations for patients with type 2 diabetes.

Would the research study be a good fit for me?
The study might be a good fit for you if:
• You are diagnosed with type 2 diabetes
• You are between 20-75 years old
• You are able to communicate in English
• Your Body mass index is between 20 - 35kg/m2
• You are not a shift worker
• You are not fasting for ≥12 hours/day
• You are willing to comply to the dietary intervention
• You DO NOT have any of the following medical conditions: Type 1 diabetes, history of malignant cancer (other than nonmelanoma), liver, kidney, respiratory, gastrointestinal, or cardiovascular disease; you are NOT pregnant or breastfeeding; you DO NOT have clinical depression; history of/or current eating disorder; inflammatory diseases (e.g. rheumatoid arthritis, Crohn’s disease, colostomy, malabsorption); you are NOT a smoker.

What would happen if I took part in the research study?
If you decide to take part in the research study, you will be asked to:
• Seek a referral to the study from your doctor
• Attend online appointments (via Zoom, phone or FaceTime) with the research nutritionist (PhD student) at the start of the study and again at 6 weeks, 12 weeks and 24 weeks.

• Fill in a 7-day food diary, a survey form which includes questions about your medical background, socio-demographic characteristics, a physical activity questionnaire, information about the medication you are taking and other health data, a wellbeing questionnaire, a Mediterranean diet adherence questionnaire and a satiety questionnaire, at the start of the study, at 6 weeks, 12 weeks and 24 weeks.

• You will be provided with a form to attend a local pathology service and have a blood and urine sample taken at the start of the study, and again at 6, 12 and 24 weeks.

• Participants assigned in the control group and the Mediterranean diet groups will be asked to consult via phone research nutritionists (PhD student and external dietitian) biweekly for 12 weeks and monthly thereafter. It will take 60 min biweekly for 3 months and 60 min per month for the following 3 months of your time for the nutrition consultations.

• For all participants, it will take 25 hours in total to be part of this study.

Will I be paid to take part in the research study?
You may be reimbursed for any reasonable travel, parking, meals and other expenses associated with the research project.

Who do I contact if I want more information or want to take part in the study?
If you would like more information or are interested in being part of the study, please contact:

Dimitra Papamichou (PhD student/nutritionist)
Department STEM
College School of Health and Biomedical Sciences of Sciences
RMIT University
Email: [email protected]