Eating nuts while breastfeeding – the Nuts For Babies Study.
Developing infant tolerance to nuts via breastmilk: a randomised controlled trial.
The Kids Research Institute Australia
4,412 participants
Jul 22, 2024
Interventional
Conditions
Summary
Australia has the highest prevalence of food allergy in the world, with at least one in every 32 (3.1%) infants developing peanut allergy and one in every 66 (1.5%) infants developing a cashew nut allergy, which are usually lifelong. Nut allergies place individuals and their families under enormous stress and have been shown to decrease quality of life. This trial aims to determine if the risk of developing peanut and cashew nut allergy during infancy can be reduced by a maternal diet rich in peanuts and cashew nuts during breastfeeding. A finding from our recent Western Australian pilot randomised controlled trial (ACTRN12617001465347) with 109 mother-infant pairs discovered that a maternal high-peanut diet, compared to a low-peanut diet, during the first six months of lactation may reduce the risk that her infant will develop a peanut allergy. We now propose a definitive efficacy randomised controlled trial, in order to provide high-quality evidence to inform maternal diet guidelines for peanut and cashew nut allergy prevention. If the hypothesis is correct, this will be a simple strategy to reduce nut allergies. If incorrect, this information will be paramount for informing breastfeeding women about food choices. Participating mothers will be randomly allocated into either a high-nut (minimum of 60 peanuts and 40 cashew nuts per week), or a low-nut (maximum of 20 peanuts and 12 cashew nuts per week) group, for 6 months from the birth of their baby. From six months of age after commencement of solid foods, both groups will be encouraged to include smooth peanut butter and cashew nut spread in their baby’s diet as per our current Australian infant feeding and allergy prevention guidelines. Infant peanut and cashew nut allergy outcomes will be assessed during infancy. This trial has been co-designed with consumers who will continue to be involved in all stages.
Eligibility
Plain Language Summary
Simplified for easier understanding
This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.
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Interventions
Maternal consumption of at least 60 peanuts and 40 cashew nuts per week from birth until 6 months post-natal. Participants will purchase their own peanuts and cashew nuts. Every 2 weeks during the intervention period, the women will be sent a mobile phone text with a link to complete a quick survey about how much peanut and cashew nut they have eaten over the past week, and whether they would like any further advice and support regarding their allocated nut diet. This will also include one question on their breastfeeding status.
Locations(1)
View Full Details on ANZCTR
For the most up-to-date information, visit the official listing.
ACTRN12624000134527