Effects of a Mediterranean-style diet and fish oil supplements on mood and health Chief Investigators INFORMATION SHEET Background and aim

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1 Effects of a Mediterranean-style diet and fish oil supplements on mood and health Chief Investigators University of South Australia: Dr Natalie Parletta, Dr Dorota Zarnowiecki, Ji Hyun (Catherine) Cho, Anthony Villani, Dr Sarah Blunden, Dr Svetlana Bogomolova, Professor Leonie Segal, Professor Kerin O Dea La Trobe University: A/Prof Catherine Itsiopoulos; Deakin University: A/Prof Felice Jacka University of Wollongong: A/Prof Barbara Meyer, A/Prof Marijka Batterham; University of Adelaide: Professor Bernhard Baune INFORMATION SHEET Background and aim If you have experienced symptoms of depression over the past 2 months or more, we would like to invite you to take part in a 6-month research project. This project involves a focus on investigating healthy diet and fish oil supplements to help improve physical health and mood. Many people know that diet is important for good physical health but not a lot of people realise how important good nutrition is also for mental health. The omega-3 fatty acids in fish oil are good for heart health and are highly concentrated in the brain accordingly, previous research indicates that they may assist some people with improving their mood and mental health. What will it involve? If you are interested in taking part, please call (08) and leave a message giving the name of the study (Helfimed), your name and your contact phone number. A member of our team will call you and ask you questions about your age, whether you have suffered from depression, and some questions about your diet to determine if you are eligible for the study. If you are eligible and agree to be involved, you will visit our clinic in the city for assessments at the beginning of the study, then at 3 months and 6 months. You will be randomly allocated to either take part in the intervention (cooking workshops, nutrition education and fish oil supplements) or a control group (regular social activity). People who are randomised to the intervention will receive a free food hamper each fortnight for 3 months and free fish oil capsules for 6 months. If you have any food allergies we will not provide any foods that you are allergic to. You will be asked to take 2 capsules containing fish oil each day, take part in nutrition education and cooking workshops, and do your best to eat and cook healthy food/meals of your choice. People who are randomised to the control group will attend a fortnightly social group. You will receive a free double movie pass as a thank you following each round of assessments that you complete. At the end of 6 months you will be given 3 months free supply of fish oil capsules and nutrition information/recipes as provided to the intervention group. 1

2 What data will be collected? As indicated above we will collect data at the beginning of the study, and at 3 and 6 months after that. These data include blood tests, a urine sample, height, weight and waist measurements, and blood pressure as well as questionnaires that will take around minutes to complete. To complete these assessments we will organise a time for you to visit the Sansom Clinical Trial Facility at the University of South Australia on Frome Road first thing in the morning after an overnight fast (i.e. no eating or drinking overnight other than water). After the blood test, urine sample, height, weight, waist/hip and blood pressure measurements are taken you will be provided with a light breakfast and then given the following questionnaires to complete: - A background, demographic questionnaire (only once at the beginning) - Psychological questionnaires about mood and emotional states - A quality of life questionnaire with 35 questions - A 14-item Mediterranean diet questionnaire You will be given a 3-day food diary at each assessment point to take home and complete on 2 week days and one weekend day, and send back to us in a pre-paid envelope provided. The blood samples will measure your apolipoprotein ratio A/B1 (a marker of cardiovascular health), fatty acids, glucose, insulin, carotenoids (antioxidants to measure increased fruit/vegetable intake), and other inflammatory and oxidative markers. A urine sample will be taken to measure your sodium:potassium ratio. These measures allow us to assess cardiometabolic (heart) health and markers of diet quality; we will be able to provide your personal fatty acid, apolipoprotein A/B1 and potassium/sodium results at the end of the study with an explanation of what they mean. If you are in the intervention group, we will ask some questions about your experience of the program in focus groups at the beginning and after 3 and 6 months and record the conversations for the purpose of transcribing the information and identifying common themes. Your identity will not be divulged in any reports generated from this data. It is designed to get your feedback and assist us to identify how successful the program is and modify and improve it as necessary. What are the benefits of participating in the study? You may not benefit directly from this study but you will be providing a valuable contribution to scientific knowledge in this field and hopefully to the awareness of the role of nutrition in mental and physical health. A summary of results will be provided to you. If you are randomised to the intervention group you will receive free fortnightly food hampers for 3 months, containing extra virgin olive oil, fruit and vegetables, nuts and legumes to assist with cooking healthy meals, along with guidance and support, and free fish oil capsules that contain omega 3 fatty acids for 6 months - all of which are good for your health you will need to take 2 fish oil capsules per day, providing 1g omega-3s. You will also learn new skills around shopping, budgeting and cooking healthy meals and be involved in group activities around cooking and eating. If you are randomised to the control group, you will receive double movie vouchers for each round of assessments, and free 3 months supply of fish oil capsules after the 6 month assessments, along with nutrition education and cooking materials that were provided to the intervention group. 2

3 Are there any risks involved? Blood samples will be taken as part of this project which introduces a slight risk of bruising and infection and could cause some distress. To minimise this risk, all blood samples will be collected by a qualified phlebotomist trained in this technique, and standard aseptic techniques used to protect against cross-infection. The fish oil capsules will be donated by a reputable supplier who has approval from the Therapeutic Goods Administration (TGA) for commercially available fish oil capsules, and dosages (1g/day) are one third of recommended upper limits for daily fish oil intake (3g/day). There are no established adverse effects from fish oil apart from fishy burps and loose stools in rare cases, and the capsules are free from gluten, sugar, dairy products, and artificial colours, flavours or sweeteners. The fish oil has been subjected to strict quality control and independent testing and is free from harmful pollutants, toxins or metals including mercury. In the unlikely event of a possible adverse effect, volunteers are asked to contact the researchers immediately to decide whether they should continue taking them. How will my privacy be protected? Complete confidentiality cannot be guaranteed regarding participation in this study although focus group participants will be requested to keep information confidential. All personal information will be identified by a code and stored securely in a locked filing cabinet in the Playford Building at the University of South Australia, for the duration of the study. After that they will be archived, with no personally identifiable information, for 15 years, after which they will be destroyed. We may take photos during cooking workshops that will go on the study website and may be used for conference presentations. If you are happy to be included in the photos please tick the box on the consent form. Any information collected from you will be used solely for the purpose of conducting this study in accordance with the NHMRC National Statement on Ethical Conduct in Research Involving Humans. The research team will have access to the data and results. All tissue samples and records containing personal information will remain confidential and no information which could lead to your identification will be released, except as required by law. If the results of this study are published, for example in scientific journals, you will not be identified by name. What if I wish to withdraw? Your participation in this study is entirely voluntary and you have the right to withdraw from the study at any time without giving a reason. If you decide not to participate in this study, or if you withdraw from the study, you may do so freely. If you choose to withdraw, your personal details will be retained along with those of the continuing participants. Your details up until your withdrawal are an important part of the data set for analytical purposes. We are also required to retain documents for clinical studies for up to 15 years, deidentified and stored securely (with ID numbers only), at the end of which all documents are confidentially destroyed. Publication Project outcomes (with no individually identifying information) will be published in conference papers and scientific journals and may be promoted by the media. 3

4 If you have further questions For further questions about the study, please contact Dorota Zarnowiecki, phone (08) , or Natalie Parletta on (08) , You are invited to discuss this with family and friends. If at any time you feel distress during the assessments or study, you are invited to contact the Psychology Clinic at the University of South Australia on (08) , (see website: for further information. We can also recommend Beyond Blue ( on , or Lifeline on This study has been approved by the University of South Australia s Human Research Ethics Committee. Should you wish to discuss the project with someone not directly involved, in particular in relation to matters concerning policies, information about the conduct of the study, or your rights as a participant, please contact the UniSA Ethics Officer, Ms Vicki Allen on ; fax ; vicki.allen@unisa.edu.au. 4

5 CONSENT FORM I, (please print your name) give consent to my involvement in the research project HELFIMED; Effects of a Mediterranean-style diet and fish oil supplements on mood and health. 1. I acknowledge that I have read and understand the attached Information Sheet entitled: HELFIMED: Healthy Eating for Life with a Mediterranean-style diet. I have had the details of the study explained to me by named researchers and I agree to take part. 2. I understand that I will either be randomised to an intervention group or a control group. Whatever group I am in I understand that taking part in this project involves visiting our clinic on Frome Road in the city to provide blood and urine samples and complete questionnaires on three occasions during a 6 month period. 3. If I am randomised to the intervention group I understand I will attend fortnightly cooking workshops for 3 months, receive food hampers each fortnight for 3 months, take 2 fish oil capsules every day for 6 months, and take part in 3 recorded focus groups. 4. If I am randomised to the control group I understand that I will attend fortnightly social groups for 3 months, receive double movie passes for each round of assessments, and receive 3 months supply of fish oil after the 12 month assessments. 5. I understand that while information gained during this study may be published, I will not be identified and my personal results will not be divulged. I understand that the research team will have access to the data. 6. I understand that I am free to withdraw from the project at any stage. 7. I understand that any information obtained from my participation will be used for the purposes of research related to this study, as specified in the information sheet. I understand that any information gained will not be released in identifiable form, nor will data be transferred to non-study personnel or organisations without approval from the ethics committee. 8. I do / do not wish to take part in group photographs for publishing in study newsletters and the website. 9. I agree to maintain confidentiality of focus group discussions and preserve the identification of focus group participation. 10. I understand data will be stored at the University of South Australia in electronic form and in locked filing cabinets for the duration of the study and then archived for 15 years. Name of Volunteer Signature of Volunteer.. Date ... Signature of Principal Investigator (or nominee)..... Date..... Contact details for researchers: natalie.parletta@unisa.edu.au (phone ); dorota.zarnowiecki@unisa.edu.au (phone ). 5