None listed
Conditions
Brief 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).
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 adhe
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.
Sponsors
Janet Weber
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
16 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
One healthy baby aged at 1-7 months; Breastfeeding, either directly from the breast, expressing and feeding your baby with expressed milk or mixed feeding, or complementary feeding
Exclusion criteria
Allergy to yeasts; Taking medicines such as Phenelzine (Nardil), Tranylcypromine (Parnate), Selegiline (Ensam, Eldepryl), Isocarboxazid (Marplan) and Meperidine (Demerol) or any other medications containing Monoamine Oxidase Inhibitors; Having health conditions or taking medications that can influence milk secretion related hormones, or milk supply; Crohn’s disease; Diabetes; Compromised immunity; Treatment for fungal infections.
Outcome results
None listed