None listed
Conditions
Brief summary
Nourish to Flourish is a non-randomised clinical pilot study with an active control involving 40 infants (and mothers) which will examine the feasibility of conducting a randomised controlled clinical trial (RCT) to support immune protection against infection. This study will be conducted in Auckland, New Zealand Study Questions: a) As solid food comprises a relatively small proportion of energy intake in infants during the first few months of complementary feeding, will young infants eat enough of the target whole food or components to potentially alter the GI microbiome and provide protection against infection? b) What are feasible measures of protection against infection at this age that parents can comply with? c) How many children would be required to undertake a fully powered clinical trial in Phase 2? d) Which outcome variables are both relevant and feasible to demonstrate the chain of effects of whole food or food components on immune health benefits? The primary objectives of this feasibility study are: • To determine whether infants will consume the target food(s) in a dose estimated to alter immune function via modification of the microbiome and associated metabolite changes. • To determine the feasibility of the outcome measurements (immune, microbiome, host/microbe metabolome), assess recruitment potential, and identify high prevalence adverse events. • To determine the number of infants that would be required for an RCT of a complementary feeding intervention for improved immune protection from infection.
Interventions
This study is a non-randomised clinical pilot study with an active control involving the recruitment of 40 infants (and their mothers) with an aim to examine the feasibility of conducting a large scale randomised controlled clinical trial developed to support immune protection against infection.
Group 1 (10 babies): You must be willing to give your baby a commercially prepared probiotic control that is known to show immune benefit(s) in young children.
Group 2 (30 babies): You must be willing
This study is a non-randomised clinical pilot study with an active control involving the recruitment of 40 infants (and their mothers) with an aim to examine the feasibility of conducting a large scale randomised controlled clinical trial developed to support immune protection against infection. Group 1 (10 babies): You must be willing to give your baby a commercially prepared probiotic control that is known to show immune benefit(s) in young children. Group 2 (30 babies): You must be willing to gradually introduce your baby to the kumara powder over 3 months until they are consuming 5 g (1 tsp) per day. Intervention: kumara powder or probiotic control Both treatment groups involve the use of accepted ingredients in infant nutrition and are manufactured in registered facilities and comply with Food Standards Australia and New Zealand guidelines with respect to manufacturing standards and compliance with food safety requirements, including allergy management.. Dose: Parents and guardians will be requested to have their infant consume the supplied kumara powder each day for a total of 6 months (i.e. from when the child turns 6 months old until they turn 1 year of age). Kumara powder: The kumara powder is prepared by mixing it with hot water to form a paste, and adding it to your baby’s food to be consumed at meal times according to your baby's routine. Begin by mixing 0.25 tsp kumara powder with 0.75 ml water (1:3 ratio) and gradually increase the amount of kumara powder mixed with water by 0.25 tsp every 2 weeks until the required 1 tsp (5g) per day is reached. After 3 months in the study (i.e. when you baby is 7 to 9 months of age, your baby should be consuming 5 g of kumara powder each day. You will be supplied with all the kumara powder required for your participation in this research for the 6 month duration of the study at no cost to you. The kumara powder or probiotic will be supplied to you every 3 month. The amount of food given to the infant will not displace other foods of important nutrient composition in the infant’s diet. The infant will be introduced to the kumara powder or probiotic control with their first complementary foods between the ages of 4 to 6 months and will be consumed daily for the 6-month period of the intervention. Adherence will be measured using information from a monthly questionnaire with parents or guardians on the average amount of kumara powder consumed per day in the previous month.
Sponsors
The University of Auckland, Faculty of Medical and Health Science
Study design
Allocation
Non-randomised trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
2 Months to 6 Months
Healthy volunteers
Yes
Inclusion criteria
Eligible study participants for the feasibility study are: Healthy infants 2 to 3 months of age are able to enroll with the expectation that they will be introduced to their first complimentary foods between 4 to 6 months of age, and not before 4 months of age, as per the Ministry of Health Food and Nutrition Guidelines.
Exclusion criteria
Infants will be ineligible for enrollment if they: Were born <32 weeks’ gestation; Have a developmental disability (i.e.,autism, intellectual disability); An illness likely to influence their nutritional status (e.g., a chronic illness known to cause malabsorption, digestive or metabolic disorders); Have health conditions that affect feeding; Are undergoing treatment with antibiotics; Are receiving a supplement with a pre and/or probiotic; Or whose parents written or spoken English comprehension is likely to make participation difficult for them.
Outcome results
None listed