The University of Auckland
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HVN SMILEY Metadata Record - Sheep and Cow Milk Complementary Food Effects on Gut Microbial Diversity - The SMILEY Pilot Study

posted on 2024-03-26, 23:19 authored by Clare WallClare Wall

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.

Description: 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.



University of Auckland

Temporal coverage: start


HVN Project / Programme Name


Data access requirements

No Individual Participant Data sharing has been approved under the ethics approval for this study.

Principal investigator organisation

University of Auckland

Collaborating researchers and affiliations

Principal Investigators: Professor Clare Wall, Head of Discipline - Nutrition, Faculty of Medical and Health Sciences, University of Auckland Professor Nicole Roy, Department of Human Nutrition, University of Otago Professor Warren McNabb, Nutritional Sciences, Riddet Institute, Massey University Associate Investigators: Dr Amy Lovell (University of Auckland) Ms Sophia Amjad (University of Auckland) Dr Philippa Miskelly (University of Auckland) Dr Eric Altermann (AgResearch) Dr Wayne Young (AgResearch) Dr Karl Fraser (AgResearch) Dr Jane Mullaney (AgResearch)

Data description

Outcomes of the Study and associated data Primary outcomes - Difference in change over time of the microbial alpha- and beta-diversity and relative abundance of specific microbial species from baseline to week 4 of consuming OMO compared to BMO and consuming OMO or BMO compared to a control diet. Associated data: Infant stool microbial composition and function Secondary outcomes - Difference in change over time of faecal short-chain fatty acids (SCFAs) from baseline to week 4 of consuming OMO compared to BMO and consuming OMO or BMO compared to a control diet. - Differences in change over time in anthropometry, sleep patterns, digestive comfort, and stool consistency and frequency from baseline to week 4 of consuming OMO compared to BMO and consuming OMO or BMO compared to a control diet. Associated data: faecal SCFAs; infant length; infant weight; composite sleep outcome encompassing night-time sleep, day-time sleep and activity, assessed using actigraphy and sleep diaries; Infant Gastrointestinal Symptom Questionnaire (IGSQ); infant dietary intake assessed using 3-day food records.

Principal investigator contact email