Phase 1 of Nourish to Flourish
You are invited to take part in Phase 1 of our Infant Complementary Feeding Study.
The purpose of Phase 1 is to:
- Determine the feasibility of conducting a large scale clinical study in infants 6 months of age
- Determine whether young infants will eat enough of the target food (powdered kumara) to alter their gut bacteria and provide protection against infection
- Determine the number of infants that will be required to undertake a large scale clinical study
- Deermine which of the outcomes meausred are relevant and feasible to demonstrate the effects of whole foods on immune health benefits.
By being part of this study, you are agreeing to give your baby the required amount of kumara powder or probiotic control for the 6 month duration of the study.
Over that time we will need your baby to participate in several measurements at four time points.
– Baseline when your baby is 2 to 3 months of age
– When your baby is 4 to 6 months of age
– When your baby is 7.5 months of age
– Completion: when your baby is 12 months of age
What measurements would we like to collect?
We would like to collect the following measurements from your baby:
Height and weight
Using standard methods and equipment e.g. measuring mat (length) and infant scales (weight)
Blood sample (optional)
A sample of blood will be taken from a vein for finger prick*. You are free to choose which method you wish to be performed. We need approximately 3-5 mL (1 tsp) and the collection only takes 5 minutes.
* This measurement hopes to provide the study team with valuable information, but participants can opt out without it affecting their participation in Nourish to Flouirsh. Please be assured that your baby’s blood will be collected by an experienced person with minimal distress for you and your baby.
Using a 3 day food record we would like to find out the types of foods that your baby eats and ask you to record any dietary supplements or traditional herbs that you may currently be using.
We hope to collect a stool (poo) sample from your baby. You will be provided with all the necessary equipment and instructions for safe collection and storage of such a sample prior to your clinic visit.
Stool collection is not an invasive or distressing procedure for your baby and a small quantity can be collected from their nappy after your baby has passed a bowel motion.
We hope to collect a urine sample from your baby. You will be provided with all the necessary equipment and instructions for safe collection and storage of such a sample prior to your clinic visit.
Samples will be obtained using a collection pad provided where clean, un-contaiminated urine can be collected from the pad using a syringe. This method of urine collectionis not invasive or distressing for your baby, and has been used successfully in many clinical studies.
We hope to collect a saliva sample from your baby. This can be collected at your clinic visit using laboratory-specific cotton swabs and collection tubes for safe storage.
This method of collection is used to minimise any undue distress for your baby.
We would like to collect the following measurements from you:
Using a Food Frequency Questionnaire, we would like to find out the types of foods that you usually eat.
Breast milk sample (optional)
We hope to collect breast milk samples from mothers who are currently still breast feeding*. Approximately 12 mL of expressed breast milk will be collected. Collection can be done either in the clinic or at home.
* This measurement hopes to provide the study team with valuable information, but participants can opt out without it affecting their participation in Nourish to Flouirsh.