Randomised controlled study of the effects of yeast based supplement on milk production in breastfeeding women
Randomised controlled study of the effects of yeast-based supplement on milk production in breastfeeding women - the Breastfeeding and Based on Yeast supplement (BaBY) Study
Janet Weber
72 participants
May 22, 2019
Interventional
Conditions
Summary
This study aims to investigate how breast milk production is affected by 4-week consumption of a yeast based supplement and any side effects for taking it while breastfeeding. Seventy two healthy breastfeeding women with one baby (not twins) will be recruited at 1-7 months postpartum and randomly selected to take a placebo (corn starch) or a yeast based supplement (5 g/day) for 4 weeks. Every mother will be visited for twice (baseline and 4 weeks after the intervention) to take milk samples for composition analysis and to assess baby's growth. Five or six online questionnaires will be administrated to evaluate mothers’ perception of milk production, health status, baby's feeding and side effects of taking capsules at different times (at the baseline, every week during the intervention and follow up to baby turns to 6 months when applicable).
Eligibility
Plain Language Summary
Simplified for easier understanding
This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
The intervention consists of 9 capsules (containing either 5 g yeast powder or placebo) per day for 28 days. Brief names for the intervention groups are Yeast and Placebo. Both yeast and placebo will be filled into empty gelatine capsules in the Food Laboratory at Massey University. The empty capsules are coloured and flavoured with orange flavour to mask the colour and flavour of yeast. The capsules will be provided in pill boxes labeling with daily dose on each small container. To monitor adherence, the researcher will contact individual participant weekly during intervention and ask her to send a photo of the capsule container to show how many capsules have been consumed. This will be used to evaluate the adherence.
Locations(1)
View Full Details on ANZCTR
For the most up-to-date information, visit the official listing.
ACTRN12619000704190