Thank you for registering your interest in participating in this clinical trial. So far, you have completed a questionnaire and provided a blood sample which has allowed us to ensure you are eligible for the study.

Below is the study information session video. This video includes an introduction into the ‘why’ we are doing the study, followed by the nitty gritty of ‘what, when and how’. We will explain the study protocol in more detail and outline what will be specifically requested of you during the study.

You will need to view this information session in its entirety. Once you have viewed the video, enter your email address below, tick the box to confirm that you have watched the video and then click the submit button. This will need to be completed prior to your next clinic appointment.

If you have any urgent questions, or have decided this study is not for you, please contact our trial coordinator, on (08) 8303 8988 or email CRUstudies@csiro.au.

Otherwise, we look forward to seeing you at your first appointment!

[Image of the SAHMRI building appears above CSIRO logo and text: CSIRO Nutrition & Health Research Clinic, www.csiro.au]

Narrator: Welcome to the CSIRO Nutrition and Health Research Clinic.

[Image shows a close-up of the base of the SAHMRI building and text appears: CSIRO Nutrition and Health Research Clinic, Our new state-of-the-art facility is located on the ground floor of the South Australian Health and Medical Research Institute (SAHMRI) on North Terrace (near the new Royal Adelaide Hospital). This brand new facility incorporates the latest technology and equipment for nutrition research and health diagnostics. CSIRO research scientists work with clinic staff to run a variety of human nutrition intervention studies that lead to improved health impacts for the Australian community]

Our new state of the art clinic is located within the South Australian Health and Medical Research Institute on North Terrace next to the new Royal Adelaide Hospital. Here our Research Scientists work with the Clinic Team to deliver gold standard clinical nutrition interventions with each study working towards improving the health of Australians.

[Image changes to show a photo of a researcher talking to a male laying back in a chair and text appears: Why should I participate? By becoming a participant you are assisting our scientific researchers to provide health and nutrition information to both Australians and global community. Scientific finding from our research are typically published in international journals. Our research is also used for the development of community diet and wellbeing programs, the development of novel foods with health attributes, as well as providing nutrition and health related recommendations to government agencies and companies.]

By participating in a study you are helping us grow and develop our understanding of nutrition and health to benefit Australians as well as the global community.

We publish our research in respected scientific journals as well as putting our knowledge to practical everyday use within the community.

[Image changes to show a researcher taking a male’s blood pressure and text appears: There are short term and long term advantages for you personally participating. Short term you will meet some new people and know you are contributing your time for a greater cause. Long term you will be contributing to the health of Australians as well as citizens worldwide. You are free to withdraw at any time during the study if you decide it’s not for you. We are also able to choose to end your participation and would explain why this was to occur.]

There are many benefits you will experience from participating. Short term you will meet some new people and know you are contributing your time for a cause. Long term you will be contributing to the health of Australians and citizens worldwide. You are free to withdraw at any time during the study if you decide it’s not for you. In some instances if we were to end your participation in the study we would explain why this was necessary.

[Image changes to show a photograph of grapes on a platter and text appears: The effect of de-alcoholised red wine on biomarkers of ageing Study, Information Session, CSIRO Nutrition & Health Research Clinic, www.csiro.au]

Today we will discuss the detail of the study that you’ve registered your interest in participating “The effect of de-alcoholised red wine on biomarkers of ageing”. Today’s information video will be an introduction into the why we are doing this study, followed by the nitty gritty of what, when and how and we will explain the study protocol in more detail and outline specifically what will be requested of you during the study.

[Text appears: Study Personnel, Principal Scientists, Professor Michael Fenech, Clinical Study Team Members, Bianca Benassi-Evans (Research Clinic Unit Leader), Anne McGuffin (Clinical Trials Co-ordinator), Theresa McKinnon (Research Nurse), Genevieve James-Martin (Research Dietitian), Gemma Williams (Research Dietitian), Megan Rebuli (Research Dietitian), Ian Zajac (Research Scientist, PhD), Varinderpal Dhillon (Research Scientist PhD), Theodora Almond (Research Assistant, B. Sc.), Tina McCarthy (Research Assistant, B. Sc.)

We have a large team involved in the study. Highlighted in blue are the people you are likely to interact with in the Clinic.

[Image changes to show a picture of a bunch of grapes and a glass of wine and text appears: Polyphenols, Polyphenols are a large class of chemical compounds found in plants, “poly” = many, phenols, which refers to the compound structure. Over 4,000 polyphenol compounds. Many are powerful antioxidants and can neutralise the effects of inflammation in the body. Resveratrol is one polyphenol compound found in red wine claimed to have anti-ageing effects]

The de-alcoholised wine study centres on the potential health benefits of wine polyphenols. Polyphenols are a large class of chemical compounds found in plants. The name refers to the fact that they are made up of many or poly phenol units which refers to the compound structure. There are over 4,000 polyphenol compounds that have been identified and we are continuing to learn about how these can be powerful antioxidants which can neutralise the effects of inflammation in the body. Resveratrol is one polyphenol compound found in red wine which you may have heard of.

[Image changes to show a bunch of grapes with juice dripping from the base next to a table displaying the potential benefits and harms of wine]

However, alcohol and wine contain a number of substances other than polyphenols and there is a balance between the harms and benefits of consuming alcohol. While wine polyphenols may have a range of health benefits from their antioxidant properties, the intake of excess alcohol brings about a range of health issues such as developmental defects if consumed during pregnancy, heart disease, accelerated ageing and cancer. At the most basic level these harms are the result of DNA damage caused by the harmful by-product of breaking down the alcohol.

[Text appears: Wine without alcohol (de-alcoholised wine), What if we could have the benefit of wine polyphenols without the detrimental health effects of alcohol? Social consumption, Pregnancy and breast-feeding, People with genetic variants who cannot metabolise acetaldehyde, the carcinogenic metabolite in alcohol common in Asian populations, People wanting to benefit from the potential brain protective effects, Study population, Overweight and obese individuals exhibit higher levels of DNA damage and are at higher risk of developing health conditions associated with DNA damage such as cancer, heart disease and neurodegenerative disorders]

More recently, alcohol reduced or removed wines have been developed. These wines have the potential to provide the health benefits of the wine polyphenols without the harms of toxic alcohol metabolites. This may benefit a range of people including those who wish to drink socially without the effects of alcohol, populations who have poor alcohol metabolism because of genetic traits common to Asian populations, pregnant or breast feeding mothers as well as anyone wanting to benefit from the potential brain protective effects of wine polyphenols. It may be particularly beneficial to people who are overweight and obese as these people are shown to have higher levels of DNA damage and are at higher risk of developing health related conditions. This is why we are conducting the study in this particular population.

[Image appears of a glass of wine next to a glass of water below text: Study aim, To test whether daily consumption of 375 m half a bottle) of de-alcoholised Shiraz wine prevents age-associated DNA damage and metabolic stress in overweight and obese men/women aged 50 years or older compared to a placebo, water. Cross-over design. You will be randomly allocated to be in the water or wine group for 8 weeks followed by the alternate group for the next 8 weeks.]

The aim of this study is to test whether daily consumption of half a bottle of de-alcoholised Shiraz wine prevents age associated DNA damage and metabolic stress in overweight and obese men and women aged 50 years or older. This will be compared to a placebo, water. The study design is a cross-over. This means you will consume both the de-alcoholised wine and the water, each for eight weeks. The order in which you consume these products will be randomly assigned.

[Image changes to show a Study Timeline table for the trial showing the three Phases]

So far you have completed a questionnaire and provided a blood sample which has allowed us to ensure you are eligible for the study. Should you choose to participate your next appointment is a consultation with a Dietitian. At this appointment you will fill out a consent form, discuss the diet protocol for the study and complete a diet recall where we will ask you about what you ate on the previous day. At this visit you’ll also complete some cognitive tests to assess aspects of your brain function such as memory and recall. After this consult you’ll start the first study phase, the Washout, which runs for four weeks. During this time you will adhere to the dietary guidelines for the study, a moderate polyphenol diet but will not consume any study products yet. This gives you time to get used to the dietary requirements and ensures that all study participants are having a similar level of polyphenol intake for the start of the study.

In Phase 2, weeks four to 12, you’ll consume 375 mils of your first test beverage, either the water or the wine. In Phase 3, weeks 13 to 20, you’ll swap to the alternate beverage and consume the same volume for the final eight weeks of the study. At visits two, three and four, you’ll have a blood sample taken. At this visit you’ll be asked to consume a dose of your current test beverage and 90 minutes later we’ll take another blood sample. This will allow us to look at the short term effects of the test beverage on the body. At these visits we’ll also check your blood pressure, repeat the cognitive function test and check in with the Dietitian to do another diet recall, as well as answering any questions you have. After each visit to the Clinic you’ll be contacted by phone by the Dietitian in the week following to do another diet recall. We’ll use this information to assess the nutrient intakes of the two study groups across the study.

[Image changes to show an outline human head with cogs inside the brain area, a joined dot network and brain scan image and text appears: Health tests during the study, DNA damage prevention tests, Oxidative stress tests, Blood pressure, Blood polyphenol level, Blood cholesterol and glucose, Blood metabolites linked to brain health, Liver function and iron status, Cognitive function, Buccal cells will also be collected to measure DNA damage prevention in tissues other than blood, You will receive your test results at the end of the study]

From your tests at the Clinic we will look at a range of health markers. These include blood polyphenol levels, cholesterol, glucose, liver function, iron status and blood metabolites linked to brain health. We’ll also look at markers of DNA damage and oxidative stress. In addition buccal cells collected from a cheek swab and saliva will be used to measure DNA damage in other tissues. Where possible we will share your results with you at the end of the study.

[Image changes to show a view of the Clinic kitchen]

Before you leave the Clinic, at each visit you’ll be provided with breakfast in our Clinic kitchen.

[Text appears: Dietary requirements during the study, Consume your test beverage (the water or wine daily). Follow the moderate polyphenol diet guidelines as instructed by the Dietitian, Don’t start a new diet or to change your diet during the study, e.g. starting a weight loss diet or going vegetarian, Record any accidental consumption of high polyphenol foods, Keep a record of your intake of your test beverage (water or wine), Return any unused product at each Clinic visit]

Now for a bit more detail about the diet. The most important aspects of the diet during the study are, Consume your test beverage (the water or wine daily). Keeping your diet the same as usual is important. We don’t want you to start a new diet or to change your diet dramatically during the study, such as going on a weight loss diet. You’ll need to follow the moderate polyphenol diet recommendations as instructed by the Dietitian. We’ll talk more about this in a moment. We’ll also ask you to record any accidental consumption of high polyphenol foods on the checklist we provide and to keep a record of your intake of your test beverage, the water or wine on the checklist we provide. Finally, we’ll ask that you return any unused product, so left over bottles of water or wine at each visit. We’ll talk a bit more about each of these points now.

[Text appears: Test beverage, Your first test beverage (water or wine) will be delivered to your home. Delivery details will be arranged at your first Clinic visit. The test beverage should be consumed each day in the evening. The test beverage can be split into two doses e.g. 187.5 mL before dinner, 187.5mL after dinner. Water will be provided in 1.5 litre bottles and you will be given a measuring container to measure your daily dose. You can freely consume other water across the day in addition to the test beverage amount. Wine will be delivered in bottles which contain exactly half of the 357mL dose. You’ll need to consume two bottles a day.]

Before the study starts, your first test beverage, the water or wine, will be delivered to your home. Delivery details will be arranged at your first Clinic visit. The test beverage should be consumed each day in the evening. It can be split into two doses, for example half consumed before dinner and half consumed after dinner. The water will be provided in 1.5 litre bottles and you will be given a measuring container to measure your daily dose. You are free to consume other water across the day in addition to the test beverage amount. The wine will be delivered in bottles which contain exactly 187.5 mils. You’ll need to consume two bottles a day.

[Image changes to show a table displaying polyphenol levels in various foods]

During the study you’ll be asked to follow a moderate polyphenol diet. As discussed earlier there are thousands of polyphenols in plants and hence many foods contain polyphenols in varying amounts. This table provides an example of some of the food and drinks we commonly consume and their polyphenol content. We are not asking you to exclude all polyphenol containing foods from your diet, just a select few which are high in polyphenols or consumed regularly.

[Image changes to show a table displaying food categories containing polyphenols and various foods in avoid, restrict and freely allowed columns]

At your first Clinic visit with the Dietitian you will discuss the dietary restrictions in detail and help you find substitutes if any of the foods you commonly consume need to be restricted. Briefly, all meat and dairy foods are allowed as well as most bread and cereal products. Soy products, such as soy milk, yoghurt and tofu are allowed in restricted amounts. You will need to restrict some fruits, avoiding plums, berries and black grapes. You can consume apples, peaches and prunes in restricted amounts and all other fruits can be eaten freely. Most vegetables are allowed freely with some restrictions on the amount of spinach, red onion and green olives.

[Image changes to show another table displaying food categories containing polyphenols and various foods in avoid, restrict or freely allowed columns]

You will need to avoid some nuts and seeds listed but others can be consumed up to a handful a day. If you use extra virgin olive oil you will need to swap this with another cooking oil. Herbal teas and some juices are excluded, along with cocoa powder, syrups or toppings containing cocoa. Coffee can be consumed but must be limited to one serve. Black or green tea can also be consumed up to one cup a day. Orange juice is limited to one serve a day. However, there are still plenty of drinks you can drink freely. You will need to avoid milk chocolate and dark chocolate during the study but you can have white chocolate. Chocolate powders such as Milo or Nesquik can also be consumed occasionally. Both study groups must avoid red wine, aside from the de-alcoholised wine provided. They also must avoid apple cider, however alcoholic beverages other than this are permitted. With the exception of cloves, herbs and spices are permitted in small amounts and we ask that you avoid starting any new supplements during the study.

[Image changes to show a picture of a hand ticking boxes on paper and feet on a pair of scales and text appears: Record keeping and monitoring, Paper-based record for keeping track of consumption of test beverage and recording any accidental consumption of high polyphenol foods, Return any unconsumed product at each visit, Weight monitored at clinic visits – weight stability is important.]

During the study it’s important that we monitor your intake of the test beverage. We’ll provide you with a paper checklist to record your daily intake of this and also to record if you accidentally consume any of the high polyphenol foods that we’ve asked you to avoid. In addition we’d like you to return any unused product, so any leftover bottles of wine or water, at each visit so that this can be counted. At each visit we’ll check your weight, as it’s important that this remains stable during the study. If your weight fluctuates the Dietitian will discuss this with you.

[Image changes to show a blue screen and text appears: Any Questions, Contact our Trial Coordinator: 08 8303 8988 or CRUstudies@csiro.au or write it down and ask at your scheduled Dietitian appointment. Thank you for taking the time to view this Information Session. This research would not be possible without your support. CSIRO Nutrition & Health Research Clinic]

Last but not least, a big thank you for taking the time to view this information session and for participating in the study. We cannot do it without you. If you have any questions, or have decided the study is not for you, please contact our Trial Co-ordinator. Otherwise, save your questions for your first consultation with the study Dietitian. We look forward to seeing you then.

[Music plays and CSIRO logo and text appears: Big ideas start here, www.csiro.au]

De-alcoholised wine and biomarkers of ageing: Study information

Note: if you experience any difficulties in watching the video or you are unclear about any of the information, please contact us on (08) 8303 8876 or email CRUstudies@csiro.au before you submit your confirmation below.

I confirm that I have viewed the study information video above in its entirety and understand the information that has been provided to me. I have noted any questions or queries I may have, and will either contact the trial co-ordinator immediately or bring these to my next clinic appointment.

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