None listed
Conditions
Brief summary
The SMILEY RCT is a double-blind, parallel, randomised controlled trial involving 105 infants who have not yet started solids and their parent/caregiver. The food-based intervention (ovine or bovine milk oat-based products) will start around 6 months of age (the recommended age for introducing complementary foods, according to the NZ Ministry of Health and World Health Organisation). The SMILEY study aims to compare the impact of consuming an infant oat-sheep milk product with an infant oat-cow milk product on the infant gut bacteria. We are also interested in exploring how the changes in microbiota may impact digestive comfort and sleep. Participants will be randomised into one of three groups (35 infants in each group), One group will receive an ovine-milk oat-based product (OMO), and another group will receive a bovine-milk oat-based product (BMO). A third group will be the control group. If randomised into the intervention groups, participants will be asked to gradually introduce the oat-based product until the infant consumes approximately 12 g of powder daily. The intervention product is prepared by mixing 12 g of the powder with cooled boiled water to form an age-and stage-appropriate consistency. Participants will be supplied with all the intervention products required for participation in this study at no cost.. Enough intervention products will be supplied for a fortnight. Gold Field Nutrition, Australia has developed the OMO and BMO intervention products and meets the Food Standards Code- 2.9.2 – Food for Infants. If randomised to the control group, participants will receive a gift voucher to the value of the provided intervention product. The primary aim of the pilot randomised controlled trial is to determine if there are changes in microbial diversity in faecal samples of infants in response to consuming OMO or BMO in the early stages of weaning. This study will be conducted in Tauranga (Bay of Plenty) New Zealand.
Interventions
Infants will be randomised 1:1:1 into one of two intervention groups or the control.
Treatment allocation to the two intervention groups will be blinded.
The intervention groups are either an ovine milk oat-based product (OMO) or bovine milk oat-based product (BMO). The intervention products will be packaged in identical sachets and provided as a 4-week supply at the baseline visit.
Dose: Participants will be asked to offer their baby the intervention product daily as per the preparation in
Infants will be randomised 1:1:1 into one of two intervention groups or the control. Treatment allocation to the two intervention groups will be blinded. The intervention groups are either an ovine milk oat-based product (OMO) or bovine milk oat-based product (BMO). The intervention products will be packaged in identical sachets and provided as a 4-week supply at the baseline visit. Dose: Participants will be asked to offer their baby the intervention product daily as per the preparation instructions (12 g powder mixed with 80 mL of cooled boiled water). The product must be prepared fresh each morning, and discard any unused at the end of the day. The intervention product should be stored in the fridge if not consumed in one sitting. Both intervention products involve the use of accepted ingredients in infant nutrition. They are manufactured in registered facilities and comply with Food Standards Australia and New Zealand guidelines concerning manufacturing standards and compliance with food safety requirements, including allergy management. The intervention products will be introduced in small amounts with the first signs of interest in food (i.e. around 6 months of age, as per the Dietary Guidelines). The intervention will be provided in a safe form for infants to consume ad libitum, where the required daily amount will not displace other foods of important nutrient composition in the infant’s diet. It is a commercially acceptable ingredient in infant food and is feasible for families to store and prepare for the duration of the study. Parents/caregivers of infants randomised to the OMO or BMO groups will be supplied with all the intervention products for participation in this research (total of 4 weeks). Adherence to the intervention will be measured using a prospective daily record completed by parents/caregivers and information on a fortnightly questionnaire regarding the average amount consumed in the previous fortnight. Adherence will be defined as consumption of the required amount of intervention on 80% of the days within the monitored interval.
Sponsors
The University of Auckland, Faculty of Medical and Health Science
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
3 Months to 6 Months
Healthy volunteers
Yes
Inclusion criteria
Infants will be eligible for participation in the study if they - Are healthy - Are between 3-6 months of age - Were at least 32 weeks gestation at birth - Are exclusively breastfed - Will be introduced to their first complimentary foods at around 6 months of age, and not before 4 months of age, as per the New Zealand Ministry of Health Food and Nutrition Guidelines for Infants - Have parents or legal guardians that can give written informed consent to participate in the study
Exclusion criteria
Infants will not be eligible for participation if they: - Were born <32 weeks gestation - Were small for gestational age (as they may have special dietary requirements) - Have a developmental disability (i.e., autism, intellectual disability) - Have an illness likely to influence their nutritional status (e.g., a chronic illness known to cause malabsorption, any digestive or metabolic disorders) - Have health conditions that affect feeding - Are undergoing treatment with antibiotics - Have had any complementary foods at recruitment - Are receiving a supplement with a pre-and/or probiotic - Are on infant formula - Have parents or legal guardians whose written or spoken English comprehension is likely to make participation difficult.
Outcome results
None listed