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 8876 or email CRUstudies@csiro.au.

Otherwise, your next appointment is a consultation with a dietitian.

We look forward to seeing you!

[Music plays and text appears on screen: Nutrition and health research clinic]

Narrator: Welcome to the CSIRO Nutrition and health research clinic.

[100 Years of Innovation logo appears on screen with text: Welcome, and thank you for joining us in this special year, as CSIRO celebrates 100 years of innovation for Australians.]

You are joining us as CSIRO celebrates 100 years of delivering scientific innovation to the Australian community and worldwide.

[New text appears below the logo: We are grateful for your interest and registering to participate in this study]

We are grateful for your interest and selfless commitment to assist us in our endeavours to make Australia a healthy nation.

[Image changes to show an outside shot of the Nutrition and Health Research Clinic building]

Our new, state of the art facility is located on the ground floor of the South Australian Health and Medical Research Institute on North Terrace, near the new Royal Adelaide Hospital.

[Image changes to show a man entering the building and being greeted by a woman who is seated behind a desk, text appears: Adelaide]

This brand new facility incorporates the latest technology and equipment for nutrition research and health diagnostics.

[Image changes to show colleagues together behind a desk]

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.

[Image changes to show scientists in a laboratory type setting conducting different experiments and tests]

[Camera stops at one of the scientists, and then moves to show a clinician performing tests on a man, text appear: Why should I participate?

  • By becoming a participant you are assisting our scientific researchers to provide health and nutritional information to both Australians and global community.
  • Scientific findings 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 put our knowledge to practical everyday use within the community. We also work with government agencies and companies to develop healthier diets, wellbeing plans and novel food products and ingredients.

[Image changes to show the same clinician with a different male, 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 a study if you decided it is not for you. We are also able to choose to end your participation and would explain why if this was to occur.]

There are short term and long term advantages for you personally in participating. Short term, you’ll 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 a study if you decide it is not for you. We are also able to choose to end your participation and would explain why if this was to occur.

[Image changes to show Jane and Genevieve standing and talking to the camera]

Jane: Hi, my name’s Jane and I’m one of the research scientists managing this study. I’m joined by Genevieve, one of our research dieticians. This information video will explain why we are doing the study and outline, specifically, what we will request of you.

Genevieve: We’ll also provide a detailed explanation of each of the clinical measures we’ll take during the study and also the dietary requirements we need you to follow for the study.

[Image changes back to show an outside shot of the Nutrition and Health Research Clinic building, with text: Advancing the metabolic health benefits of almonds. Information Session]

Narrator: Today we will discuss the details of the study that you have expressed an interest in, the study called Advancing the metabolic health benefits of almonds.

[New text appears: Team – the people you will meet – Clinical Research Team

  • Julia Weaver, Anne McGuffin, Vanessa Courage, Jessica Winkler, Lindy Lawson, Heather Webb, Julie Syrette, Brad Klinger, Bianca Benassi-Evans, Genevieve James-Martin, Gemma Williams.

The people behind the scenes – Science Team

  • Grant Brinkworth, Welma Stonehouse, Jane Bowen, Natalie Luscombe-Marsh, Cuong Tran, Campbell Thompson, Geraint Rogers, Nathan Johnson, Carly Rosewarne

Laboratory Research Team

  • Vanessa Russell, Cathryn Pape, Emma Watson]

During this study you will meet many of the CSIRO Clinical Research Team. There is also a really big team of researchers working behind the scenes and in our laboratory.

[Image changes to show an animation of the Effect of obesity on health: Obesity sits in the middle surrounded by circles labelled (starting at the top and moving clockwise) Sleep Apnoea, Excess Liver Fat, Diabetes, High blood pressure, Coronary heart disease, Abnormal blood fats (e.g. high cholesterol), Stroke, Impaired Glucose Tolerance]

And now for some background information to explain why we are doing this study. In recent years, overweight and obesity has become an increasing health issue in Australia and globally. Excess body weight causes health complications and diseases such as Type 2 Diabetes and cardiovascular disease. What we eat and the types of snacks we consume also contribute to these health conditions, so this study will investigate the effects of consuming different snacks on a range of health outcomes that are associated with overweight and obesity. Some of these include excess fat stored in the liver, blood glucose control, diabetes risk and diabetes control, along with blood fats and blood pressure.

[New text appears: Background – Nuts and almonds

  • Nuts are an important part of healthy eating patterns
  • Nuts contain compounds that affect many processes in your body
  • There is strong research evidence for many health benefits from eating almonds, including

Improved weight management

Healthy blood fat profile

  • But there is less understood about the effect of eating almonds and nuts on:
  • Blood glucose control
  • Liver fat levels
  • Gut health]

Nuts, including almonds, are an important component of healthy eating patterns. Research has shown that eating almonds can help with weight management and can improve blood fat profiles. However, less is known about the effect of almonds on blood glucose control, fat stores in the liver and gut health.

[New text appears: Study Aim

To replace between meal snacks for 8 weeks with either:

  • 2 servings of almonds (56 g / day)
  • 2 servings of sweet biscuits
  • as part of an individual’s regular diets; and observe effects on:
  • Blood glucose control
  • Fat stores in the liver and abdomen
  • Liver function
  • Gut health
  • Body weight, and fat and muscle levels
  • Indicators of heart health
  • Other markers of metabolic health]

So this study aims to investigate the effect of daily consumption of either almonds or sweet biscuits over eight weeks on blood glucose control, fat stores in the liver, liver function, gut health, body weight, body fat and muscle levels and other markers of cardio vascular disease risk.

[Next text appears: Study Design – 8 Week intervention

We will provide all your snacks in individual portions for the whole study. A stick figure with text: Randomly assigned to, with arrows pointing to two boxes with more text, from left to right: Almond Group Consume almonds: 2 servings per day: 1 morning snack (28 g), 1 afternoon snack (28 g). Control Group Consume shortbread biscuit 4 per day: 2 in the morning, 2 in the afternoon]

In this research study participants will be randomly allocated into either the Almond Group or the Control Group, we will provide all the study snacks in individual portions.

[New text appears: Dietary protocol

Test snacks

  • Replace your usual mid meal snacks with test snacks (biscuits or almonds).
  • Consume your test snacks twice a day between meals, along with your usual diet.
  • Consume them at least 1 hour before or after a main meal.
  • To ensure your weight remains the same we will advise you on foods of a similar energy value to substitute.]

You will need to consume your test snacks, the almonds or biscuits, twice each day as a mid-meal snack. By this we mean at least one hour before or after a main meal period, this could be at morning tea, afternoon tea or supper. If you currently consume mid-meal snacks this would mean simply substituting the test snacks for your current snacks. If you don’t usually consume snacks the study dietician will be able to discuss how best to incorporate the almonds or biscuits into your diet without adding extra energy. This may mean replacing a small amount of food or drink from a main meal with the test snacks to ensure your weight remains stable across the study.

[New text appears: Dietary protocol

Nut and seed free diet

  • Avoid other nuts and seeds which are whole, in paste or meal form
  • You do NOT need to avoid foods which say “May contain traces of nuts or seeds” or nut and seed oils or milks e.g. sesame oil, almond milk]
  • We will provide guidance on how to identify these foods and suggest similar substitute foods]

Aside from adding the almonds or biscuits, the other important dietary component of the study will be to follow a nut and seed free diet. The nut and seed free diet will commence from two weeks prior to your first study measurements being taking and continue until the end of the study. This is an important part of answering our research question as we want to make sure that any changes we see during the study are related to the test snacks rather than other habitual consumption of nuts and seeds in the diet.

This means avoiding nuts and seeds which are in whole, paste or meal form, such as in breads, breakfast cereals, spreads, biscuits, cakes and savoury dishes. You do not need to avoid foods which say “May contain traces of nuts or seeds” or avoid nut or seed milk such as almond milk or oils such as sesame oil, just foods which contain the whole nuts or seeds as an ingredient. The study dietician will help you identify nuts and seeds in your diet and suggest similar substitute foods.

Apart from the avoidance of nuts and seeds in your diet and the addition of the study snacks we ask that you keep your diet the same as usual and do not make any sudden changes during the study, such as commencing a weight loss diet.

[New text appears: Participation

Inclusion criteria for participation are:

  • Males and females aged 20-70 years
  • Body mass index (BMI) ≥ 27kg/m²
  • Elevated waist circumference
  • Elevated blood glucose level OR previously medically diagnosed type 2 diabetes
  • Weight stable (i.e. no more than 3 kg weight loss/ gain in the past 2 months)]

To be eligible to participate in this study we are looking for males and females who are aged between 20 to 70 years, who have a body mass index above 27 and have an elevated waist circumference, they must also have elevated blood glucose levels or previously diagnosed type 2 diabetes, must also be weight stable.

[New text appears: Participation

Exclusion criteria:

  • Usage of medications/supplements, health conditions and lifestyle factors that may affect the study outcomes
  • Have Type 2 diabetes and using oral hypoglycaemic and/or insulin medication or have an HbA1c > 10%
  • Body weight above 140 kg due to technical difficulties with MRI liver scans
  • History of smoking during 6 month prior to the study
  • History of heavy alcohol consumption (>4 standard drinks /day)
  • Known allergy to nuts, dairy or gluten, or not willing to consume, test foods
  • Women who are attempting to become pregnant, lactating
  • Extended absences due to travel or other commitments
  • On any weight loss program
  • Past history of claustrophobia
  • Presence of any ferrous metal in the body]

If any of the criteria on this screen apply to you, you will not be able to participate in this study. Now, so far you have completed a medical questionnaire, the next stage of the screening process involves coming to our clinic for a finger-prick blood sample, this may be followed by a venous blood sample, you will need to fast overnight before coming in for this screening appointment. This means no food or beverages from midnight prior to coming to the clinic. The results of these blood samples will enable us to ensure you are eligible for the study and safe to participate.

[Image changes to show more details of what the process entails and an outline of what’s required, entitled: Study requirements and Clinic Appointments]

If you are eligible and choose to participate your next appointment will be with a dietician at our clinic in about two weeks before starting the snacks. You’ll be asked to give written informed consent; the dietitian will also discuss the dietary requirements of the study, provide you with any study materials, provide all your times for clinic appointments and, of course, answer any questions you might have. After this appointment you will need to start excluding all nuts and seeds from your diet and continue this until the study is finished. During the first week you will need to complete a weighed food record over three days at home, the dietician will explain how to do this. You will then come into the clinic one week before starting the snacks for an hour long appointment. A continuous glucose monitor will be fitted, you will wear this on your body for the next seven days, during this week you will need to collect a single faecal sample, we will provide you with all the necessary materials and instructions to do this in a discreet and hygienic way, you will be asked to bring this faecal sample into the clinic on the day that it’s collected or the following morning. The sooner this goes into our freezer the better.

At the end of seven days of glucose monitoring you will come back into our clinic for another morning appointment after fasting overnight. This appointment will take approximately three hours; we will remove the glucose monitor and perform a range of other tests. Again, you will need to fast overnight prior to this appointment. Before you leave you are always welcome to help yourself to breakfast at our clinic kitchen, you also start eating the snacks on this day.

A few days after this long visit you will be asked to go to St. Andrews Hospital on South Terrace in the city, this is for an MRI scan of your abdomen and liver, these appointments are all scheduled very early in the morning and they are a very costly test and the appointments are difficult to secure, therefore, your attendance at your allocated time is very important to us and to the study.

Over the next four weeks you then consume your allocated snacks twice a day, there will be a simple daily checklist to complete. We will also send you a weekly email with a link to a short, simple, online questionnaire, this questionnaire allows us to check how you’re going. At the four week mark, you come back into the clinic to collect more snack foods and be weighed; you don’t need to fast for this appointment.

At the end of the study we ask you to repeat the same procedures that you did at the beginning of the study, so you will complete a three day weighed food record, during the sixth week you’ll come into the clinic to have your glucose monitor fitted and while you’re wearing that monitor we will ask you to collect another faecal sample and bring it to the clinic. After seven days of wearing the monitor you will come back to the clinic for the same measures, after an overnight fast. Within a few days of this visit you will have your final MRI scan at St. Andrews Hospital.

[New text appears: Clinical Assessments:

  • Body weight, blood pressure and waist circumference
  • Body Composition (fat mass and fat free mass) measured using bioelectrical impedance scales.
  • Fast, simple, non-invasive test
  • No discomfort or risk
  • Required to wear light clothing
  • Venous blood sample will be taken to measure blood glucose, cholesterol and markers of liver function and inflammation. Total of 60 ml of blood per visit.]

We are now going to provide you with a bit more detail about the specific assessments that we will perform at the beginning and end of this study. Body weight, blood pressure and waist circumference will be measured. We will measure the amount of muscle and body fat using bioelectric impedance scales; this is a fast, simple, no-invasive test that does not involve any discomfort. You’ll be required to wear light clothing for this, but it is not suitable for anyone with an implanted electrical device. A blood sample will be taken to measure blood glucose, cholesterol and markers of liver function and inflammation; this will involve approximately 60 mls of blood per visit. With any blood sample, whether it is done here at CSIRO or a doctor’s office, there is a small risk of infection and bruising, however, all samples will be taken by our very experienced Nurses using standard aseptic techniques to decrease any risk and discomfort.

[New text appears: Clinical Assessments – Continuous Glucose Monitoring

  • Wireless sensor worn for 7 days
  • Sensor probe inserted under skin
  • Provides daily blood glucose profile
  • Finger-prick glucose reading required for unit calibration (4 per day)
  • Return to clinic for removal]

Continuous glucose monitors are a commercially available and routinely used device in diabetes management. They are a wireless sensor about the size of a fifty cent piece, which is worn for seven days. The device has a sensor probe that is inserted under the skin; these devices provide us with daily blood glucose profiles so we can see the effect the snacks have on blood glucose control. For these sensors to work they need to be calibrated using finger-prick blood glucose readings four times per day. After seven days you will return to the clinic and have the sensor removed. Just like a blood sample, there is a small risk of infection when you insert the probe under the skin. However, this risk is very small and our staff our well trained.

[New text appears: Clinical Assessments – Dual Sugar Test

  • Consume a drink that contains small quantities of 2 types of sugar: rhamnose and lactulose.
  • 90 minutes later a blood sample is collected to measure the level of these sugars in your blood.
  • This test provides an indicator of healthy gut function.]

The Dual Sugar Test provides an indicator of healthy gut function and will help us to determine how the consumption of different snacks might affect gut health. To do this, participants consume a drink that contains small quantities of two types of sugar, rhamnose and lactulose, 90-minutes later a blood sample is collected to measure the level of these sugars in your blood. This test will be completed while you are here at the clinic with us.

[New text appears: Clinical Assessments – Magnetic Resonance Imaging

  • Performed by qualified radiographer
  • Uses magnetic field to measure liver fat level
  • Test involves lying on your back inside the scanner for ~20 – 25 minutes
  • You will need to change into a gown
  • Please wear underwear with no metal clips, wires or metallic threads]

The MRI is performed by a qualified radiographer and uses a magnetic field to measure the amount of fat in your liver. This test involves lying on your back inside the scanner for approximately 20 minutes. You will need to change into a gown, please remember to wear underwear that does not have metal clips, wires or metallic threads.

[New text appears: Clinical Assessments – Magnetic Resonance Imaging

  • Scanner tube you lie in is around 70 cm wide.
  • Test is painless.
  • Some people feel a warm sensation during the scan while others feel nothing
  • Lie very still while pictures are taken. Scanner is very noisy; hearing protection will be provided and you have option to listen to music radio
  • All appointments are at St. Andrews Hospital, South Tce, Adelaide, early in the morning.

APPOINTMENTS EXTREMELY VALUABLE.

The tube of the scanner that you will lie is around 70 cm wides, the test is painless, although some people feel a warm sensation during the scan. You will need to lie very still while the pictures are taken, the scanner can be quite noisy, but we will provide you with hearing protection and you will also have the choice to listen to music or the radio. All appointments are at St Andrews Hospital, South Tce in the city and all appointments are early in the morning. Remember, these appointments are extremely valuable, so please do your best not to miss them.

[New text appears:

Clinical Assessments – Faecal Sample

  • Single faecal sample collected hygienically and discretely at home.
  • Collection and storage materials and instructions will be provided.
  • Keep sample cold at all times by storing in the esky provided with frozen ice bricks.

Please bring into clinic same day (before 4 PM) or morning after collection. The sooner we can put into a freezer the better]

The faecal sample will be collected at the beginning and the end of the study at your convenience at home. Our method for this is very hygienic and discreet. All the collection and storage materials along with instructions will be provided. We ask that you keep this sample as cold as possible by storing it in the esky with the frozen ice bricks provided. Please bring this sample to the clinic on the same day that you collected it, before 4 PM or the morning after collection. The sooner we put this into our freezer the better.

[Next text appears: Dietary Protocol

Dietary Assessment

  • At Week 0 and 7 complete a 3-day weighed food record, including 1 weekend day
  • Weigh and record all foods consumed
  • We can loan you digital scales if you do not have your own
  • Keep your diet the same as usual]

To gain a better understanding of your usual dietary habits we will ask you to complete a three day weighed food record before the study starts and during week seven. This means that you’ll weigh and record all your food and drinks consumed for a three day period, including at least one weekend day. We will provide instructions on how to complete the weighed food record and can loan you a set of digital scales if you don’t have your own. Again, during this time it’s important that you keep your diet the same as usual, we understand that weighing and recording your food can make you more aware of your intake and this may encourage you to make different food choices, but we ask that during this time you try to keep your diet the same as usual.

[New text appears: Recording and monitoring

Compliance to the diet is key for answering our research question

  • Daily paper record for keeping track of:
  • Snack consumption
  • Any accidental nut or seed consumption
  • Any changes to medication, supplements or health
  • Entered online weekly
  • Weight monitored at clinic visits]

Finally, we will need you to keep a record of your consumption of the test snacks and let us know if you accidentally consume any nuts or seeds, or if you have any changes to your health or the medications you are taking throughout the study. We will give you a paper record to keep track of this and at weekly intervals you’ll be prompted to enter this information online in a short, two minute questionnaire. Your weight will also be monitor each time you come into the clinic and you’ll receive advice from the dietician if your weight increases or decreases significantly throughout the study.

[New text appears: Study Approval and Medical Supervision

  • This study has been approved by a nationally accredited Human Research Ethics Committee.
  • The Study will be overseen by a Physician.
  • If tests reveal any adverse medical condition we will inform you and ask you to follow up with your General Practitioner.]

The risk associated with the procedures in this study have been outlined here and in the participant information sheet. This study has been approved by a nationally accredited Human Research Ethics Committee and the study will be overseen by a Physician. If the tests reveal any medical condition such as high blood pressure, we will inform you and ask you to follow up with your General Practitioner.

[New text appears: Completion of Study Acknowledgement

  • Provided with a $200 Coles Myer Gift Voucher
  • Acknowledge your participation and to reimburse you for travel costs
  • If you withdraw from the study before completing, we will offer a pro-rata payment scaled to reflect the duration of your participation (i.e. ~$33 per visit completed).]

At the completion of this study you’ll be provided with a Coles Myer Voucher to the value of two hundred dollars. This is our way to thank you for your time in taking part in this research project and to reimburse for your travel costs. If you wish to withdraw during the study we will offer a pro rata payment scale to reflect the duration of your participation.

[Image changes to show a photograph of a person standing on top of rocks with their hands outstretched and text: Thankyou for volunteering!! Questions? Ask a member of the research team]

And last, but not least, a very big thank you for taking the time to view this information session. We cannot do our research without you. If you any urgent questions or have decided the study is not for you, please contact our Trial Coordinator, otherwise jot down your questions and save them for your first consultation with the study dietitian. We look forward to seeing you soon.

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

Advancing the metabolic health benefits of almonds: information session for participants

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.

Advancing the metabolic health benefits of almonds

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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