Novel processed carrot-based products to supplement vegetable intake

Size: px

Start display at page:

Download "Novel processed carrot-based products to supplement vegetable intake"

Drusilla Stanley
5 years ago
Views:

HEALTH AND BIOSECURITY Novel processed carrot-based products to supplement vegetable intake INFORMATION SHEET HUMAN RESEARCH ETHICS COMMITTEE NUMBER: 06/2017 INTRODUCTION Each year CSIRO performs a

1 HEALTH AND BIOSECURITY Novel processed carrot-based products to supplement vegetable intake INFORMATION SHEET HUMAN RESEARCH ETHICS COMMITTEE NUMBER: 06/2017 INTRODUCTION Each year CSIRO performs a number of research projects involving human participants. We examine the effect of different foods and diets on health, wellbeing and risk factors for lifestyle diseases. People all over the world do not meet the recommended intake for fruit and vegetables. In Australia, the standard advice to increase vegetable intake is not effective. New strategies and options are needed to help people to boost their vegetable consumption. Carrots are an exceptional source of carotenoids, as well as fibre. Carotenoids are a precursor for vitamin A, one of the most common deficiencies worldwide, essential for eye health and may have various other health benefits through their antioxidant activity. Carotenoid levels in the blood are a good indicator of fruit & vegetable intake, however blood samples are difficult to collect and expensive to measure. Non-invasive, painless, fast methods to assess carotenoid status for example through scanning the eyes or collecting cheek cells, may hold significant potential. WHAT IS THE AIM OF THIS STUDY? This study aims to: 1. Investigate whether daily consumption of a carrot-based powder added to various foods is an effective strategy to supplement vegetable intake compared to daily intake of fresh carotenoid rich vegetables, as assessed by blood carotenoid levels. 2. Investigate consumer s attitudes towards inclusion of a carrot powder in their usual diet as a strategy to supplement vegetable intake. 3. Investigate links between blood carotenoid levels and assessment of carotenoid levels through non-invasive measures; eye imaging; and measuring carotenoids in cheek cells. 4. Investigate whether daily consumption of carotenoid rich products improve blood vessel structure of the retina and macula of the eye. 5. Investigate whether changes in carotenoid status as a result of consuming carotenoid rich products will result in changes in cognitive functioning. Who can participate? If you would like to participate, you are asked to complete the enclosed screening questionnaire and return to us by post, or complete online. If you meet a set of eligibility criteria as described below we will invite you to attend an appointment so we can further assess whether you are suitable for participating in this study. This assessment will be conducted at the CSIRO Nutrition and Health Research Clinic located at the South Australian Health and Medical Research Institute (SAHMRI) on North Terrace in the Adelaide CBD. Below are the selection criteria for the study.

2 Inclusion criteria: 1. Healthy male or female adults, years 2. Body mass index between kg/m2 (assessed by clinic staff) 3. Blood pressure <140/90 mmhg (assessed by clinic staff) 4. Able to understand the study requirements and agree to participate 5. Willing to adhere closely to the prescribed food consumption as per the research protocol Exclusion criteria: 6. History of chronic disease e.g. type 2 diabetes, heart disease, cancer, atherosclerotic disease, hypertension, stomach ulcers, drug abuse or alcoholism 7. History of pancreatic insufficiency or other conditions resulting in fat malabsorption - chronic pancreatitis, cystic fibrosis, coeliac disease, crohns disease, gastric bypass surgery, small bowel resection, abnormal thyroid function 8. History of smoking during 6 months prior to study 9. Extended absences due to travel or other commitments 10. Known allergy to the test foods, and anyone with severe food allergies - even in trace amounts. 11. Pregnancy or breastfeeding 12. Nutritional supplements that may affect the study outcomes 13. On any weight-loss programs WHAT WILL BE INVOLVED? The study will run over a total period of 5 weeks. Participation in this study will involve coming to the CSIRO Nutrition and Health Research Clinic (located on North Terrace in the Adelaide CBD) 3 times (see Figure and Table below); ~1 week before the intervention begins and at weeks 0 and 4. In between these clinic visits you will be requested to complete surveys online. All visits to the clinic and surveys will be organised with you by the trial manager.

3 The pre-intervention clinic visit (clinic visit 0, ~1 hour) will take place about 1 week before the intervention commences. Firstly, your eligibility for the study will be confirmed. We will ask you to sign a screening consent form after which we will measure your blood pressure, height and weight (stand on scales while wearing light clothing). Once these assessments have been completed and you are found to be eligible for the study you will participate in an information session during which the study will be explained to you in greater detail and you will have the opportunity to ask questions before signing a written informed consent form for participating in the study. You will then have a practise session on completing some of the cognitive tests that will be administered on an ipad. You will also be asked to stop consuming certain vegetables, foods and dishes that are high in carotenoids, (e.g. carrots, tomatoes) for four days before the week 0 clinic visit. A team member will provide detailed diet instruction of this wash out period. The clinic visits in Week 0 and 4 (~1 hour) will take place in the mornings. You will be required to fast from midnight prior to these two visits. At the conclusion of these visits you will be offered refreshments prior to leaving the clinic. You will be randomly allocated to one of two groups, which will differ in the way you will boost your vegetable intake. One group (22 participants) will be advised to boost their current intake of vegetables by an additional 2 serves per day of carotenoid rich vegetables, such as carrots, broccoli or tomatoes. People in this group will be given written instructions and a voucher to the value of $70 to cover the additional cost of buying these vegetables over the 4 week period. The other group (22 participants) will be asked to consume 2 servings of carotenoidrich powder (carrot powder) per day which will be supplied. One serving (i.e. one tablespoon) will be equivalent to 1 carrot. This can be added to a variety of foods, such as soup, pasta sauce, gravy, casserole, smoothie, yoghurt, juice etc. People in this group will be given written instructions and the carrot powder. You will be requested to continue your habitual diet and not to make any other changes to your diet apart from adding these products. WHAT WILL BE MEASURED? Before starting the study (week 0) and at the end of the study (week 4) the following tests will be conducted in the clinic (see Figure above and Table below): Blood sample (4 ml, approximately 1 teaspoon), Weight (Body Mass Index will be calculated), Body composition (Bioelectric Impedance Analysis), Blood pressure, Retinal image/eye scan (Fundus camera), Collect cheek cells sample by wiping the inside of your mouth with a soft toothbrush, Cognitive function tests delivered on an ipad. Preceeding the 4-day washout period before week 0 and at 4 weeks participants will complete an online dietary habits survey. In week 0,1,2,3 and 4 all participants will complete a short survey on attitudes towards the study foods. The surveys can be done on your home computer or mobile device, (or in the clinic in week 0, 4). Each day, at home you will be asked to fill in a brief paper-based checklist to indicate when and how you consumed your allocated foods.

4 Summary of Study Measurements. Week -1 (-7 days) Visit 0 Week 0 (Visit 1) Week 1 Week 2 Week 3 Week 4 (Visit 2) Information session & consent Height Weight Blood pressure Diet instructions Collect intervention products/ voucher Outcomes Blood sample collection Retinal image / eye scan Cheek cell collection# Cognitive function Body composition Online consumer attitudes survey Intervention compliance Practise * Paper based checklist completed daily # Extra samples will be stored for later exploration of genetic markers related to aging and carotenoid uptake * Preceeding 4-day washout period WHAT ARE THE BENEFITS OF PARTICIPATING IN THE STUDY? You may not benefit directly from participation in this study, but you will be providing a valuable contribution to the scientific knowledge in this field. Participants will be provided with a body composition profile print-out and a summary of the overall study findings. At the completion of the study you will be provided with a Coles/Myer voucher to the value of $150 to thank you for your time to take part in this research project and to reimburse you for travel costs to attend your appointments. If you withdraw from the study before completing, we will offer a pro-rata payment scaled to reflect the duration of your participation. ARE THERE ANY RISKS INVOLVED? There is a very minor risk of bruising from venous blood sampling. Bloods will be taken by a trained and experienced phlebotomist to minimise risk. There may be some inconvenience from Having to avoid certain vegetables 4 days before the clinic visit in week 0. Having to consume the test foods (either carrot powder or vegetables) during the study. Attending the city based clinic during the study. If our tests reveal that you have high blood pressure, we will inform you and ask you to follow up with your General Practitioner.

5 All human research undertaken by the CSIRO must comply with the values, principles, governance and review process specified in the NH&MRC National Statement on Ethical Conduct in Human Research (2007). A copy of the National Statement can be found at HOW WILL MY PRIVACY BE PROTECTED? CSIRO is governed under the Privacy Act 1988 (Cth). CSIRO is collecting your personal information for the purposes of conducting the study and related scientific research. CSIRO will only use and disclose your personal information in accordance with the Privacy Act 1988 and the NH&MRC National Statement on Ethical Conduct in Human Research (2007, Updated 2015) as amended from time to time, and as otherwise required by law. In relation to studies conducted by CSIRO, it is customary for all personal information to be identified by a code and stored at CSIRO under lock and key for a period of 7 years (or 15 years in the case of a drug study). Except where otherwise required by law or a government body, at the end of this period your records will be destroyed or permanently de-identified. Where third parties are assisting CSIRO in relation to the conduct of this study (such as university staff, students and other health professionals), we may disclose your personal information to those third parties for this purpose on a confidential basis. CSIRO will require such third parties to keep this information confidential and to only use your personal information for the purposes of the study and otherwise in accordance with the Privacy Act You and, with your permission, your doctor will be notified of any medical condition deemed significant by the Clinical Research Unit Medical Officer. We will not use or disclose your information for direct marketing purposes. CSIRO may publish study results and data in research publications and press releases, however, CSIRO will de-identify any personal information contained in the data and results so that you can not be identified. WHAT IF I WISH TO WITHDRAW? You are free to withdraw at any time during the study. If you choose to withdraw, all samples provided by you up to that date and your personal details will be retained along with those of the continuing participants. Your personal details, questionnaire data and samples up until your withdrawal are an important part of the data set for analytical purposes and will be retained. It is also important to understand that we can choose to end your participation, too. That decision would be made if we decided that the study is not in your best interest, if you are unable to follow the protocol of the study, or if the study is discontinued. If we ever have to end your participation, we will make sure you understand the reasons why. YOUR OBLIGATIONS AS A PARTICIPANT You will need to inform a study staff member of any changes in your health as some changes could have an effect on your participation in the study and the study findings. You must also be able to attend all visits and undertake all relevant procedures during the study period. IF YOU HAVE FURTHER QUESTIONS Please call or send crustudies@csiro.au This study has been approved by the CSIRO Human Research Ethics Committee. If you would like to speak with someone with respect to ethical matters the Secretary of the Committee can be contacted via at HREC@csiro.au. If you wish to register a formal complaint about the conduct of this research project please contact the Office of the Research Clinic Manager, CSIRO, PO Box 10041, Adelaide BC, SA 5000 or via (bianca.benassi@csiro.au).

STUDY THE BIG BREAKFAST STUDY

STUDY THE BIG BREAKFAST STUDY PARTICIPANT INFORMATION SHEET Name of Investigator: Name of Study: Dr Alex Johnstone STUDY 804 - THE BIG BREAKFAST STUDY You are invited to take part in a research study. Before you decide whether to volunteer,