RecruitingACTRN12624000134527

Eating nuts while breastfeeding – the Nuts For Babies Study.

Developing infant tolerance to nuts via breastmilk: a randomised controlled trial.


Sponsor

The Kids Research Institute Australia

Enrollment

4,412 participants

Start Date

Jul 22, 2024

Study Type

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

Sex: FemalesMin Age: 18 YearssMax Age: 50 Yearss

Plain Language Summary

Simplified for easier understanding

Australia has one of the highest rates of nut allergy in the world — affecting around 3% of infants for peanuts. These allergies are usually lifelong and can be serious. A small earlier study suggested that when breastfeeding mothers eat plenty of peanuts, their babies may be less likely to develop a peanut allergy — possibly because proteins passed through breast milk help train the baby's immune system early. This large, definitive trial — the Nuts For Babies Study — will find out once and for all whether a high-peanut and high-cashew diet during the first six months of breastfeeding reduces nut allergy in infants. Mothers are randomly assigned to eat either a high-nut or low-nut diet during breastfeeding, and their babies are assessed for nut allergy during infancy. You may be eligible if you are pregnant with a single baby and planning to breastfeed. You must not have a peanut or cashew nut allergy yourself (as you'd be unable to safely eat the required amounts). This is a simple, dietary-based study that could help prevent one of the most common and frightening childhood food allergies.

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 int

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)

WA,VIC, Australia

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ACTRN12624000134527