HVN SUN Metadata Record - Seeding throUgh FeediNg: nourishing the infant microbiome to support immune health

This metadata record and it's attached files make statements about the kinds of data collected as part of this research, and set out policies for governance of that data, now and in the future.   

The SUN RCT is a double-blind, randomised controlled trial and will involve 300 infants who have not yet started solids and their mothers. The food-based intervention (kumara powder) will start at around 6 months of age (the recommended age for introduction of complementary feeding, according to the NZ Ministry of Health and World Health Organisation recommendations). The study will be completed four months after the introduction of solids (i.e., when your baby is around 10 months of age). 

Participants will be randomised to one of three groups (100 infants in each group). One group will receive a standard kumara powder, another group will receive the kumara powder with an increased amount of resistant starch (prebiotic) from banana, and a third group will be the control group. The control group will not be required to give their child any kumara powder. If randomised to a kumara group, participants will be asked to gradually introduce the kumara powder their baby is consuming approximately 5 g (1 tsp) of powder per day. The kumara is prepared by mixing the powder with hot (not boiling) water to form an age-and stage-appropriate paste and adding it to infant food(s). Participants will be supplied with all the kumara powder required for participation in this study at no cost. The kumara powder will be provided every 2 months at your clinic visit. Both kumara groups involve the use of an accepted ingredient in infant nutrition (kumara) which is manufactured in a registered facility that complies with Food Standards Australia and New Zealand Guidelines, with respect to manufacturing standards and compliance with food safety requirements, including allergy management. If randomised to control group, participants will receive a gift voucher to the value of the provided kumara. 

The purpose of the SUN RCT is to determine whether a food (kumara), consumed as a first food, will be beneficial to the development of the infant microbiome (the bacteria within the digestive tract) and whether this can support infant immune health (including illness frequency and sleep behaviours). Resistant starch is a carbohydrate that resists digestion and acts as a prebiotic food for the good gut bacteria. This study will be conducted in Auckland, New Zealand.