RecruitingACTRN12619000704190

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


Sponsor

Janet Weber

Enrollment

72 participants

Start Date

May 22, 2019

Study Type

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

Sex: FemalesMin Age: 16 Yearss

Plain Language Summary

Simplified for easier understanding

Many new mothers worry about whether they are producing enough breast milk for their baby. This study is investigating whether a yeast-based supplement — a natural product — can help boost milk supply when taken daily over four weeks. Breast milk production is influenced by many factors, and researchers want to understand whether this supplement makes a meaningful difference. The study will recruit 72 breastfeeding women who have babies aged between 1 and 7 months. Half of the women will receive the yeast-based supplement (5 grams per day in capsule form), while the other half will receive a placebo capsule made from cornstarch. Neither group will know which they are taking. Researchers will visit each mother twice — once at the start and once after four weeks — to collect small milk samples and check the baby's growth. Online questionnaires will track how mothers feel about their milk supply and any side effects. This study is open to breastfeeding women (including those who are expressing or mixed feeding) who have a single healthy baby aged 1–7 months. Women with a yeast allergy, Crohn's disease, diabetes, or compromised immunity are not eligible. If the supplement works, this could offer a safe, accessible option to support breastfeeding mothers.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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

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)

Manawatu-Wanganui, and Wellington City along the west coast., New Zealand

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ACTRN12619000704190