Seeding throUgh FeediNg: nourishing the infant microbiome to support immune health
Seeding throUgh FeediNg: nourishing the infant microbiome to support immune health 'The SUN' randomised controlled trial
The University of Auckland, Faculty of Medical and Health Science
300 participants
Jan 27, 2022
Interventional
Conditions
Summary
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.
Eligibility
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Interventions
This study remains a double-blind, randomised controlled trial with 300 infants who have not yet started solids and their mothers. Infants will be randomised into one of three groups: control arm (C), standard kumara intervention (K), and a kumara intervention with added resistant starch from bananas (K+) to be consumed daily for a period of 4 months, until the infant is approximately 10 months old. The kumara intervention product for the K and K+ groups will be the same freeze-dried kumara product that was used in the feasibility study (ACTRN12618000157279) and approved for use in the original study design. The banana resistant starch will be added to the K+ kumara to provide a product which is 8g/100g of resistant starch. This will provide approximately 2g of resistant starch per serving per day. Food Standards Australia New Zealand permit the addition of inulin derived substances (non- starch polysaccharides) to infant foods at 1.6 g/serve (Standard 2.9.2 and 2.9.3). Studies of infants provided with 4.5g of inulin per day in weaning foods have demonstrated that this is well tolerated with no adverse effects reported. The kumara powder is intended to commence as soon as parents /caregivers introduce the first complementary food to their infant and is to be offered daily until infants are consuming approximately 5 g (1 tsp) of powder per day. The kumara powder is prepared by mixing the powder with hot (not boiling) water to form an age-and stage-appropriate paste, where it can be eaten alone or added to infant food(s). The kumara powder has been shown to be acceptable food for infants with no recorded adverse effects, in a previous pilot study (ACTRN12618000157279). It is provided in a form that can be consumed ad libitum and the required daily amount will not displace other foods of important nutrient composition in the infant’s diet. Parents/caregivers of infants randomised to the K and K+ groups will be supplied with all the intervention food for participation in this research for a total of 4 months, where the study will be completed when infants are around 10 months of age. Adherence to the intervention will be measured using a prospective daily record completed by parents/caregivers and information from a monthly questionnaire on the average amount of kumara powder consumed per day in the previous month.
Locations(1)
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ACTRN12620000026921