The GUMLi Trial is a three-year research programme focusing on nutrition in toddlers aged from age 12 months through to 24 months of age.
This research project is being conducted in two locations: Auckland, New Zealand and Brisbane, Australia.
Good nutrition in early life is one of the key determinants of a healthy child.
The "Growing Up Milk - "Lite" Trial or GUMLi Trial is a three-year research project which aims to find out if consuming Growing Up Milk - "Lite" has the ability to improve your child's health
Click on the icons to the right to find out more about the GUMLi Trial
Complete an Expression of Interest Form and a member of the research team will be in contact with you.
Can Growing up milk improve your child's body composition, nutritional status, cognitive/brain development, and general health?
|Associate Professor Clare Wall||Mrs Tania Milne||Miss Amy Lovell|
In the first two years of life a toddler’s diet is highly variable and is marked by the transition from consumption of a single food to meal and snack patterns that closely resemble that of an adult.
These formative years are where eating behaviours can act as a foundation for future eating patterns later in life.
Whilst we are well versed in the dietary recommendations for infants in the first 12 months of life, there is limited information on the dietary behaviours, intakes and patterns and appropriate validated tools used to assess this between the ages of 12 – 23 months.
The Dietary Intake Study aims to collect information that will contribute to our knowledge surrounding the dietary behaviours, dietary patterns and nutrient intakes of New Zealand and Australian toddlers aged 12 – 23 months. This is an area of research where there is limited information.
This study will validate the multi-nutrient Food Frequency Questionnaire (FFQ) – EAT FFQ for the description of nutrient intakes in New Zealand and Australian infants aged 12-24 months.
To determine if toddlers consuming toddler milk with a reduced energy content have better dietary profiles as determined by dietary pattern analysis and nutrient analysis.
To assess the relative validity and reproducibility of the multi-nutrient EAT FFQ for describing nutrient intakes and dietary patterns of New Zealand and Australian toddlers aged 12-23 months.
Little is known about the dietary intakes of children aged 12 – 23 months in both New Zealand and Australia. There is a need for complete information within this age range in order to enhance current knowledge and the dietary guidance given during this period of transition. Participation in the Dietary Intake Study will contribute to this body of information.
Participation in this additional study will provide valuable information into the dietary behaviours, dietary patterns and nutrient intakes of toddlers aged 12 – 23 months. This will allow us to look at each study toddler’s dietary patterns and nutrient intakes.
On enrolment into the GUMLi Trial, parents and caregivers of the study toddlers will be asked to take part in the Dietary Intake Study.
We will ask parents/caregivers to give consent for the collect additional dietary information recorded in a Food Frequency Questionnaire (FFQ) and in four repeated record assisted 24 hour food recalls, conducted during the monthly telephone follow ups (months 7, 8, 10 and 11).
These food recalls will contain questions about the quantities of foods and drinks your child has consumed in the 24 hours before the phone call.
This study will begin at month six of the main GUMLi Trial (the toddlers will be 18 months of age). At this time point parents/caregivers and the study toddler will attend the clinic for their mid-way review.
At this six month appointment, the Food Frequency Questionnaire will be administered again, and parents and caregivers will be given an Information Pack on the additional Dietary Intake Study.
This will include:
Four Record Assisted Food Recalls (identifying the study infant’s dietary intake over the last 24 hours) will be conducted over the next six months until completion of the GUMLi Trial.
If you chose not to consent to taking part in this study, it will not affect your child’s inclusion in the GUMLi Trial or any other involvement with The University of Auckland.
|Professor Peter Davies||Doctor Rebecca Hill||Miss Misa Matsuyama|
The aim of Child Health and Resident Microbes (CHaRM) study is to explore the development of intestinal microbiota in children participating in the GUMLi trial. This part of the study will be conducted in Brisbane only.
To explore how nutrition, environment, and health impact the gut microbiota development in Australian toddlers aged 12-24 months.
In our body, there are ten times more bacterial cells than our own cells, and they play very important roles in our health and wellbeing. Our intestine is the home to the largest population of bacteria, and they are referred to as ‘gut microbiota’. The gut microbiota aid in digestion of certain foods, regulate energy metabolism, produce important vitamins (B and K), strengthens the immune system, and helps combat pathogens. Recent research has also revealed the role of microbiota in sending signals to the brain, potentially affecting mood and behaviour.
The gut microbiota development starts from the time we are born. The gut microbiota is very unstable and undergoes rapid changes in the first few years of life until the microbiota population becomes more stabilised in adulthood. Various factors influence the composition of gut microbiota including environment, health status, age, and medication, especially antibiotics. By far, what we eat has the most impact on our gut microbiota.
Maintaining a balanced gut microbiota may be the key to our health and wellbeing. However, scientists are yet to determine the ‘healthy’ microbiota composition.
Research in gut microbiota is an exciting and emerging area of science around the world, because of increasing discoveries and understanding of the role of microbiota in our health, due to advancing technologies. To date, the most non-invasive method to identify gut microbiota is through faecal (stool) analysis. Most research on gut microbiota in babies focuses on the first year of life, especially around the first six months when milk is the only source of diet. Studies have also identified that babies’ gut microbiota goes under a major change once solid food is introduced. However, fewer studies have focused on the gut microbiota development in the second year of life, e.g. 1 to 2 year old toddlers.
To understand the interaction between diet and developing gut microbes in toddlers, the GUMLi trial will be incorporating the dietary study as well as the gut microbiota analysis.
We will be collecting faecal (stool) samples from participating children when changing nappies during the 12 month course of the study. These samples will be processed and analysed using the latest technology to monitor the gut microbiota development over one year. In addition, a one-off stool sample will be collected from mothers of participating children to identify how similar the gut microbiota profile of mothers is compared to that of their children. We will provide all equipment for stool collection with clear instructions, so the process should be very simple and easy.
The purpose of this study is to compare whether drinking toddler milk (Growing up milk 'lite') instead of cow's milk for 12 months improves nutritional status, cognitive development and levels of body fat in children aged 1-2 years.
This study will involve asking the parents/guardians of 160 children who are about to turn 1 year of age to take part. This study will take place at the same time in two cities, Auckland, New Zealand and Brisbane, Australia. In each city 80 children will be enrolled.
You will be supplied with all the milk necessary to take part in this research over the 12 months of the study at no cost to you. Milk will be supplied every three months. By being part of this study you are agreeing to give your child the required amount of milk (300ml per day) over the 12 months of the study.
Growing Up Milk (GUM) was developed in recognition that the dietary transition from infancy to toddlerhood can sometimes be difficult and that some toddlers are vulnerable to inadequate nutrition.
Growing Up Milk – Lite (GUMLi) is a cow’s milk based toddler milk that is similar in composition to the commercially available Aptamil Gold+ Toddler Milk (Danone Pty Ltd), but has a reduced energy content. Growing Up Milk is also fortified with additional nutrients, probiotics and prebiotics in comparison with standard cow’s milk.
At each of these time points we will also give you the milk your child will need to consume over the next 3 months. The measurements your child will need to perform are outlined below. You will also be telephoned once a month over the 12 months of the study, just to make sure you have no concerns or issues and to check on your child's health.
By being part of this study you are agreeing to give your child the required amount of milk (300ml per day) over the 12 months of the study (this is equal to two “small” 150mL bottles).
The milk is to be made up using the scoop inside the tin. To make the correct amount, add three level scoops (fill lightly and level) of milk powder to 130mL of drinking water. This will provide the required 150mL serve of milk. This is to be done twice daily. If your infant requires more milk, please use standard cow’s milk.
The GUMLi Trial is being conducted in two locations: Auckland, New Zealand and Brisbane, Australia
Parents or guardians of a child who is going to turn 1 year old in the next few months.
Taking part in this study may help you understand the growth and development of your child over their second year of life. By consuming the study milk, completing the measures and questionnaires we hope you gain an understanding of how your child's eating habits and nutrition can influence their development; physically, mentally and emotionally. This is useful information and is likely to benefit you and your child medically.
You should also understand that your involvement in this study is of great value to the researchers, and provides them with the opportunity to determine whether toddler milk is of benefit in the growth and development of children. Your participation is greatly appreciated by the research team, thank you for considering taking part in this study.
If you participate in this study, you need to be aware that completing this study will involve your child consuming the required amount of supplied milk (300ml per day) over the 12 months of this study. You also need to be aware that one of the measurements to be performed is a blood test. Please be assured your child's blood will collected by an experienced person with minimal to no distress for your child. All of the measurements in this study will be performed by experienced people.
The research team have designed the questionnaires with the potential for inconvenience in mind, and have removed or avoided any unnecessary questions. We have attempted to ensure these questionnaires are as easy as possible to complete.
The researchers treat protection of your personal information as a matter of high priority. Your confidentiality and privacy are assured during your participation in this study; the researchers will de-identify all personal information provided by you. There is no risk that you will be able to be identified should the results of this study be published (see point 7 below). You will only be identified by number in resultant manuscripts, reports or publications. No names will be used.
As with any research, there may also be risks associated with the research that are presently unknown or unforeseeable.
The GUMLi team require your child to have 300mL (two bottles of 150mL) of study milk each day. If your child required milk in addition to the study milk, we ask that you provide standard cow’s milk only.
If you are breastfeeding and would like to take part in this trial as well, that is fine – as long as you are willing to give your child 300mL (two bottles of 150mL) of study milk each day. Breastfeeding on top of this will not affect study outcomes.
The GUMLi Trial is registered with the Australia, New Zealand Clinical Trial Registry. Registration number: ACTRN12614000918628
Ethical approval has been sought at both study locations.
Your clinic visits will take place at the Faculty of Medical and Health Science in the Clinical Research Centre.
The Clinical Research Centre is a dedicated space for clinical research.
It is located at Level 4, Faculty of Medical and Health Science, 85 Park Road, Grafton, Auckland MAP.
Study participants are able to access parking in the basement of Building 505 MAP
Please contact Tania Milne if you think you will have problems coming in to the clinic. Travel arrangements can be made.
Your clinic visits will take place The University of Queensland, Children’s Nutrition Research Centre, Body Composition Laboratory.
It is located at the, Ground Floor Coles Building, Royal Children's Hospital, Herston. MAP.
Please contact the Brisbane research team if you think you will have problems coming in to the clinic. Travel arrangements can be made.
Discipline of Nutrition
School of Medical and Health Sciences
The University of Auckland
Tania Milne: 027 8075917
Amy Lovell: 027 8075919
Children’s Nutrition Research Centre
The University of Queensland
Phone: 0428 093 998
Growing Up Milk ‘Lite’ complies with Food Standards Australia New Zealand guidelines with regards to manufacturing standards and complies with food safety requirements, including allergy management. This product is manufactured in a registered facility.
There are no known ingredients included in, or missing from, the Growing Up Milk ‘Lite’ formulation compared with cow’s milk, which might conceivably cause harm.
The requirements for the study are that our enrolled toddlers drink 2 x 150ml serves of the study milk each day (300mL in total). If your toddler wanted to have any more milk during the day we ask that they only consume standard cow’s milk. This is to avoid any potential effects of other toddler milks on the study outcomes
If you were breastfeeding this is something that can be continued throughout the course of the study with no effect on outcomes.
If you are breastfeeding, you can continue throughout the course of this study. We encourage and support breastfeeding throughout this trial.
Our toddlers are randomly allocated to either receive GUMLi or standard cow’s milk. This process of randomisation is not known by the research team or participants until the conclusion of the study.
Growing Up Milk is a milk drink that has been especially formulated for toddlers from one year of age to support growth and development in addition to normal dietary intake. The key point to stress, is that the milks your child will be randomised to receive over the 12 months of the study are not the only source of nutrition for your child, and while there are differences in their composition, because your child will be consuming other foods and drinks over the study, we believe there are no risks to your child’s nutritional health because of drinking either milk.
The GUMLi milk used in the study is a standard cow’s milk based toddler milk that is largely similar to an available and compliant commercial product currently on the market. The main difference is that GUMLi has reduced energy (calorie), protein, saturated fat, and sugar content. There are no known ingredients included in, or missing from, the GUMLi formulation compared with cow’s milk, which might conceivably cause harm.
GUMLi has also been fortified with additional essential vitamins and minerals, including iron to support mental development, and calcium and vitamin D to support bone health and teeth. GUMLi is also supplemented with unique probiotics and prebiotics (good bacteria and carbohydrates that support healthy digestive and immune systems) in comparison with standard cow’s milk.
This study has received ethical approval from:
The Northern B Health and Disability Ethics Committee (Reference: 14/NTB/152)
The University of Queensland Institutional Human Research Ethics Committee (Reference 2014001318)
From an exposure to x-ray radiation perspective, it is important to know that not all x-ray exposures are equal, and it is easiest to understand if we compare different types of x-ray radiation to natural background radiation. We are exposed to natural background radiation every day, so a few different types of x-rays are compared below in terms of a single days’ worth of background radiation. All values will be given in numbers of days.
So you can see from comparison with other types of radiation exposure that the exposure from the two scans in our trial is very small, being less than half a day of natural background radiation exposure. At this dose level, no harmful effects of radiation have been demonstrated as any effect is too small to measure. These types of risks are categorised by the Australian Radiation Protection and Nuclear Safety Agency (ARPANSA). The risk for the 2 DXA scans is classified as minimal and falls into ARPANSA Category I (risk <1 in 100,000), which is described as:
“The dose range for this project category is less than 0.2 mSv which is the dose delivered by natural background radiation in a few weeks. It is considerably less than the variations in annual dose from natural background radiation to persons living in different locations, and the risk level is considered minimal. The level of benefit needed as the basis for approval of research with doses in this category will be minor and will include those investigations expected only to increase knowledge.”