PARTICIPANT INFORMATION SHEET

 Project title: ANABP 01 in Preventing cardiometaboLic disEase risks (APPLE Study)

 Chief Investigator: Dr. Ruey Leng Loo

 The Australia National Phenome Centre (ANPC) and the Centre for Computational and Systems Medicine (CCSM) invite you to participate in a research study that can help advance our understanding of human health and consumption of an apple variety called Bravo™ apple.

We are seeking volunteers who are willing to consume apples and pears on a daily basis. As part of this study, we will collect biological specimens such as urine, blood, and/or faeces, which will be analysed using cutting-edge analytical techniques to understand which components could be beneficial for health.

If you are interested in taking part, or if you would like to find out more about the study, please read the enclosed information leaflet carefully. This leaflet tells you more about the study.

If you decide to take part in the study, you will be asked to sign an electronic consent form.  If you do not wish to take part, there is nothing you need to do.

  

Who are we?

The Australian National Phenome Centre (ANPC) is a research centre funded by the WA State Government, the Australian Research Council, and Murdoch University.  The ANPC is dedicated to developing and delivering metabolic phenotyping (fingerprinting) research to advance human health.

 

What is the purpose of the study?

Apples are widely recognised for their beneficial contribution to health when incorporated into a well-balanced diet. They contain vitamins, minerals, antioxidants and fibre, all of which have been shown to have a positive effect on health. However, different apple varieties have varying levels of these beneficial compounds, particularly antioxidants known as polyphenols.

Polyphenols have been linked to lowering blood cholesterol and reducing the risk of heart disease. In this study, we aim to investigate the extent to which a specific Western-Australian bred apple variety called Bravo™ apple, which is high in polyphenols, would have on chronic diseases such as diabetes and cardiometabolic disease risk.

Existing human studies on the effects of apples are often conducted using supplements rather than consuming the whole fruit. Additionally, volunteers are frequently instructed to follow specific diets. We want to understand what impact including the fruit as part of a normal diet has. Thus, our study aims to fill in these gaps in knowledge.

In our research, we will investigate how Bravo™ apples impact different biochemical (fingerprint) changes in the body. By understanding this, we can potentially contribute to the prevention of chronic diseases such as diabetes and heart disease. Our findings will help us provide accurate health advice to public healthcare providers.

 

What are the inclusion criteria?

During the screening visit, the researcher will check the following:

  • You are an adult over the age of 18.
  • Your body mass index is between 20 -30 kg/m2.
  • You are at risk of developing diabetes and/or cardiometabolic disease based on the AUSDRISK score ³ 9 with at least one risk factor other than age or gender.

 

What are the exclusion criteria?

You will be excluded from the study if you:

  • Have a medical history of heart disease, diabetes mellitus, kidney, liver or pancreatic diseases or gut disorders.
  • Are currently taking medication for high cholesterol, high blood pressure, gut disorder, long-term anti-inflammatory medication intake and immunosuppressants.
  • Are pregnant (current or planned), or lactating.
  • Have a history of alcohol misuse.
  • Have been prescribed a course of antibiotics within the last 2 months.
  • Currently take food or vitamin supplements (e.g. fish oil) unless you are willing to stop for 1 month before study commencement.
  • Consume more than one apple and/or pear per day.
  • Are on a special diet e.g. vegetarian or vegan diet or planned weight loss regimen.

 

 What is involved in the study?

This study will involve a total of 11 clinic visits, each lasting for about 30 mins, over the study period of 20 weeks. For the first 8 weeks, you’ll eat  either apples or pears in addition to your regular diet. Then, you’ll take a break for at least 4 weeks. After the break, you’ll spend the next 8 weeks eating only the fruit you didn’t eat before. So, the study will last at least 20 weeks.

 

Screening clinic visit

During the screening clinic visit, the following will be conducted:

  • Eligibility assessment using AUSDRISK and exclusion criteria questionnaire.
  • Review presentation of a 5-minute video demonstrating how to complete Intake 24, an online 24-hour food diary.
  • Utilisation of a demonstration version of Intake 24.
  • Training on capturing a picture with a timestamp, so that you can provide evidence of fruit consumption.
  • Instruction to maintain habitual diet (avoiding probiotics/prebiotics, apple, or pear-containing foods).
  • Individuals eligible to take part in the study and can follow the study protocol will be invited to attend the clinic visit the following week.

 

Study clinic visits

During each clinic visit,  you will arrive fasted for a minimum of 12 hours. The following measurement and data collection will take place:

  1. Resting blood pressure, fasting blood sugar, anthropometrics (weight, height, hip, and waist measurements).
  2. Collection of fasting plasma and serum specimens, first-morning mid-stream urine.
  3. Collection of stool sample at home prior to visit (optional).
  4. Submission of completed Intake 24 (including 2 days on a weekday and a weekend). Intake 24 can be completed at any time, as long as you remember what you have eaten on the specified days.
  5. Supervised consumption of 360 g of apple or pear.

You will be asked to attend a total of four study clinic visits. The first visit will occur at the start of the study, the second visit will take place during week 8, which marks the completion of study period one. The third visit is scheduled for at least 4 weeks after the end of first intervention period and also coincides with the start of the second intervention period, and the last clinic visit will occur at week 20.

 

Food collection clinic visits:

You will participate in six food collection clinics.  These clinics will take place at weeks 2, 4, 6, 14, 16 and 18. During these visits, you will collect your fruit at the Australian National Phenome Centre. Additionally, you will be supervised while consuming the provided apples or pears and submit a completed Intake 24 at weeks 4 and 16.

A flow diagram of the study visits including the various specimen collections is shown below.

What are the benefits and risks of taking part in this study?

There are several benefits to you in taking part in this study:

  • You will be provided with apples/pears for 16 weeks.
  • The blood pressure, and blood sugar results will be provided to you. Where appropriate, if any test results with potential relevance to health risk are identified, you will be informed and advised to seek further medical advice from your GP.
  • You will help to improve the advancement of research into how apples may affect health and this information may be used to shape public health policy.
  • As a token of gratitude, you will be provided a gift voucher worth $50 after the completion of the first intervention period, and $100 at the end of study period. If you travel by car, we will reimburse parking at the Harry Perkins Building.

 

There are several risks to you in taking part in this study:

  • Inconvenience – participation in this research project involves 11 clinic visits, each visit will last approximately 20-30 mins. These visits include the collection of blood, urine and ideally faecal samples, as well as a supervised consumption of the test food. Additionally, you will provide a daily timestamp of the apple/pear food waste as an evidence of food consumption.
  • Blood collection will be performed by a qualified phlebotomist who will withdraw a total of 20 mL of blood (a tablespoon) at each visit. There are minimal risks associated with the collection of blood and urine specimens. However, for blood collection, some individuals may notice minor discomfort, bruising and soreness at the puncture site. Occasionally some individuals may also experience light-headedness, dizziness or fainting, but these symptoms usually go away quickly. The risk of these side effects is low as the volume that we are collecting is small. Very rarely, drawing blood may result in an infection, but this risk is small if appropriate hand hygiene guidelines are followed. There are no foreseeable adverse consequences for providing urine or faecal specimens.
  • Incidental findings – This research project includes blood, urine and faecal testing to identify potential markers related to the consumption of apples or pears. There is a very small chance that these tests may result in the incidental discovery of information that is relevant to your health. Since the samples will be de-identified and analysed in batches in a non-clinical laboratory with investigational techniques, the data will be de-identified. If any findings are deemed medically relevant, the research team will re-identify you.  You will have the options to “provide the results to my GP so that further medical assessment can  take place” in the consent form.

 

What will happen to the samples and information?

All specimens (urine, blood, and/or faeces) and electronic data will be labelled with a computer-generated random code to prevent identification. The specimens will be stored in a −80 °C freezer or liquid nitrogen vapour storage facility.

Various biochemical techniques will be used to analyse these samples. Specifically, the blood samples will be analysed to provide information about your lipoproteins and lipids, which help us understand your heart disease risk. The urine samples will be tested to identify molecules that appear after you consume food and other compounds that might be affected by eating the apples/pears. Some of these compounds come from gut bacteria. The faeces will be examined to learn about the types of bacteria in your gut and important substances these bacteria produce from digesting the fibres in apples.

Electronic data and samples will be de-identified and stored securely throughout the research period and for at least 15 years after the final publication of results.  Access to the samples and data will be limited to designated researchers who have undergone appropriate training and have been granted permission by the principal investigator.

 

What are the withdrawal criteria?

You are free to choose whether to participate in this study or withdraw at any point. If you decide to withdraw, we will keep the data (such as your age and gender information) and samples (such as urine, blood and/or faeces) already collected as part of the research project.  You do not need to take any action regarding the retained data and samples unless you want them to be destroyed.  If you wish to have your data and samples destroyed, please send an email to [email protected] with a statement like: “I wish to withdraw from this study, and I request that all my personal data and collected samples be destroyed”.  Upon receiving your request, the research team will destroy the data and samples, usually within one week.  You will be notified via email once this process is complete.

 

What will happen to the results of the research study?

It is likely that the results from this study will be published in a scientific journal or presented at scientific conferences. However, it will not be possible to identify individuals of any results from this study.  We may also share our analysis with other research collaborators to advance scientific knowledge, but they will not be able to identify you.

We do not intend to inform you of the results.  However, we will inform you of your blood pressure and blood sugar reading, unless you do not wish to be informed of this information.  Further information on the study will be released on the ANPC webpage, and you can follow updates (e.g. publication of results) on this study via the ANPC webpage.

The Department of Primary Industries and Regional Development and Fruit West (the funders) are likely to use the results from this study to encourage people to eat more fruit.

 

Where will the study take place?

All clinic visits will be conducted at the Harry Perkin South dedicated Clinical Room, located at 5 Robin Warren Drive, Murdoch 6152.

 

Who funds this study?

This study is funded by the Future Food System Cooperative Research Centre in partnership with Murdoch University, the Department of Primary Industries and Regional Development and Fruit West. Fruit West will provide the Bravo apple variety and pears used in this study.

 

Who has approved this study?

This study has been reviewed and approved by the Murdoch University Human Research Ethics Committee (reference number 2024/086).

 

What if I have a question?

If you have any questions regarding any aspect of this study, you can speak to Dr Ruey Leng Loo, who will be happy to answer all your questions.

 

What if there is a problem?

If you have a concern about any aspect of this study, you should ask to speak to the researcher who will do their best to answer your questions. If they are unable to resolve your concern or you wish to make a complaint regarding this study, please contact Dr. Ruey Leng Loo. If you wish to talk with an independent person, you may contact Murdoch University’s Research Ethics & Integrity on Tel. 08 9360 6677 (+61 8 9360 6677 for overseas studies) or e-mail [email protected]. Any issues you raise will be treated in confidence and investigated fully, and you will be informed of the outcome.

 

Dr Ruey Leng Loo (Chief investigator)

Tel: 08 9360 1371

Email:[email protected]

Address: Murdoch University, Harry Perkin South Building, 5 Robin Warren Drive, Murdoch