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Trial registered on ANZCTR


Registration number
ACTRN12619000704190
Ethics application status
Approved
Date submitted
6/05/2019
Date registered
10/05/2019
Date last updated
10/05/2019
Date data sharing statement initially provided
10/05/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Randomised controlled study of the effects of yeast based supplement on milk production in breastfeeding women
Scientific title
Randomised placebo-controlled study of the effects of yeast based supplement on milk production in breastfeeding women - the BaBY Study
Secondary ID [1] 298079 0
None
Universal Trial Number (UTN)
U1111-1205-0106
Trial acronym
BaBY Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
insufficient breast milk production 312591 0
Condition category
Condition code
Reproductive Health and Childbirth 311099 311099 0 0
Breast feeding

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 314311 0
Treatment: Other
Intervention code [2] 314413 0
Prevention
Comparator / control treatment
The control group will take placebo capsules (containing starch) with the same colour and flavour.
Control group
Placebo

Outcomes
Primary outcome [1] 319916 0
Amount (g) of expressed milk obtained by the fourth expression of hourly expression method established by Kent JC et. al
Timepoint [1] 319916 0
Baseline, 2 weeks (primary timepoint) and 4 weeks
after intervention commencement
Secondary outcome [1] 369853 0
Self reported breastfeeding pattern assessed using 24-hour feeding record (specifically designed for this study)
Timepoint [1] 369853 0
Baseline and 4 weeks after intervention commencement
Secondary outcome [2] 369854 0
Postnatal distress assessed by DASS-21 scale
Timepoint [2] 369854 0
Baseline and 4 weeks after intervention commencement
Secondary outcome [3] 369855 0
Perceived insufficient milk production assessed using a questionnaire specifically designed for this study
Timepoint [3] 369855 0
Baseline, 1 week, 2 weeks, 3 weeks and 4 weeks after intervention commencement, and at follow up (baby turns to 6 months old)
Secondary outcome [4] 369856 0
The duration of exclusively breast feeding and/or breast feeding assessed using a questionnaire specifically designed for this study
Timepoint [4] 369856 0
Baseline, 1 week, 2 weeks, 3 weeks and 4 weeks after intervention commencement, and at follow up (baby turns to 6 months old)
Secondary outcome [5] 369857 0
Self-reported side effect associated with yeast supplementation assessed using a questionnaire specifically designed for this study. The documented side effects of yeast supplementation in human studies include constipation, skin rash, decreasing appetite and nausea.
Timepoint [5] 369857 0
Baseline, 1 week, 2 weeks, 3 weeks and 4 weeks after intervention commencement
Secondary outcome [6] 370176 0
Milk fat tested by AOAC method
Timepoint [6] 370176 0
Baseline, 2 weeks and 4 weeks after intervention commencement
Secondary outcome [7] 370177 0
Milk IgA tested by commercially available Multiplex
Timepoint [7] 370177 0
Baseline, 2 weeks and 4 weeks after intervention commencement
Secondary outcome [8] 370178 0
Milk IL-6 tested by commercially available Multiplex
Timepoint [8] 370178 0
Baseline, 2 weeks and 4 weeks after intervention commencement
Secondary outcome [9] 370179 0
Milk IL-10 tested by commercially available Multiplex
Timepoint [9] 370179 0
Baseline, 2 weeks and 4 weeks after intervention commencement
Secondary outcome [10] 370180 0
Milk IGF-1 tested by commercially available enzyme-linked immunosorbent assay (ELISA) kits
Timepoint [10] 370180 0
Baseline, 2 weeks and 4 weeks after intervention commencement
Secondary outcome [11] 370181 0
Milk leptin tested by commercially available Multiplex
Timepoint [11] 370181 0
Baseline, 2 weeks and 4 weeks after intervention commencement
Secondary outcome [12] 370182 0
Milk ghrelin tested by commercially available enzyme-linked immunosorbent assay (ELISA) kits
Timepoint [12] 370182 0
Baseline, 2 weeks and 4 weeks after intervention commencement
Secondary outcome [13] 370183 0
Milk protein tested by AOAC method
Timepoint [13] 370183 0
Baseline, 2 weeks and 4 weeks after intervention commencement
Secondary outcome [14] 370184 0
Infant weight measured by the researcher using infant scale
Timepoint [14] 370184 0
Baseline, 2 weeks and 4 weeks after intervention commencement
Secondary outcome [15] 370185 0
Infant length (heel to crown) measured by the researcher using an infant length board and recorded to the nearest millimetre
Timepoint [15] 370185 0
Baseline, 2 weeks and 4 weeks after intervention commencement
Secondary outcome [16] 370186 0
Infant head circumference over the most prominent part on the back of the head (occiput) and just above the eyebrows (supraorbital ridges) measured by the researcher using a flexible, non-stretch tape
Timepoint [16] 370186 0
Baseline, 2 weeks and 4 weeks after intervention commencement

Eligibility
Key inclusion criteria
One healthy baby aged at 1-4 months;
Breastfeeding, either directly from the breast, expressing and feeding your baby with expressed milk or mixed feeding (1-2 formula feeds a day with the total amount not over 100 mL)
Minimum age
16 Years
Maximum age
No limit
Gender
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Start complementary feeding;
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
A technician who is not involved in the trial will create the randomisation sequences. Study capsules are packed in identical enrollment package and stored in separate boxes with label of Yeast/Placebo on the boxes. Allocation sequences are kept by the technician in a secure place and not accessible to anyone else, including the researchers. Once the participant is recruited, the technician will label the enrollment package with the special study code based on the allocation sequences and give the package to the researcher.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Block randomisation using a randomisation table created by computer software
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
The sample size estimation is based on the milk production from hourly milk expression method established by Kent JC et. al. The overall coefficient of variation (CV) for hourly milk production is 30% and the within subject CV is less than 10%. We aim to pick up a 10% increase of milk production in the yeast group and no increase in the placebo group at the power of 80%. Thus, the estimated sample size is 40 participants in each group. Considering the high drop off rate in breastfeeding study (about 30%), 120 participants will be recruit for this study.
Open-ended questions will be coded and entered into IBM SPSS statistics 25 with other quantitative data. Quantitative data will be tested for normality and then described as appropriate using mean (standard deviation) or median (25, 75 percentile). Categorical data will be reported as frequencies. Chi square tests will be used for categorical data analysis. Magnitude of change of placebo and yeast group’s milk production and composition at 2 and 4 weeks from baseline will be assessed using repeat measures ANOVA. Mann–Whitney U-test will be applied for non-normally distributed variables. Logistic regression will be conducted where perceived insufficient milk production is the dependent variable.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 21445 0
New Zealand
State/province [1] 21445 0
Manawatu-Wanganui

Funding & Sponsors
Funding source category [1] 302610 0
University
Name [1] 302610 0
Massey University
Address [1] 302610 0
Massey University
Private Bag 11 222
Palmerston North 4442
Country [1] 302610 0
New Zealand
Primary sponsor type
Individual
Name
Janet Weber
Address
School of Food and Advanced Technology
College of Science
Massey University
Private Bag 11 222
Palmerston North 4442
Country
New Zealand
Secondary sponsor category [1] 302522 0
Individual
Name [1] 302522 0
Lili Jia
Address [1] 302522 0
School of Food and Advanced Technology
College of Science
Massey University
Private Bag 11 222
Palmerston North 4442
Country [1] 302522 0
New Zealand
Secondary sponsor category [2] 302562 0
Individual
Name [2] 302562 0
Louise Brough
Address [2] 302562 0
School of Food and Advanced Technology
College of Science
Massey University
Private Bag 11 222
Palmerston North 4442
Country [2] 302562 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303244 0
Massey University Human Ethics Committee: Human Ethics Southern A Committee
Ethics committee address [1] 303244 0
Research Ethics Office, Research and Enterprise
Massey University
Private Bag 11 222
Palmerston North 4442
Ethics committee country [1] 303244 0
New Zealand
Date submitted for ethics approval [1] 303244 0
30/10/2018
Approval date [1] 303244 0
26/02/2019
Ethics approval number [1] 303244 0
SOA 18/80

Summary
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.
One hundred and twenty healthy breastfeeding women with one baby (not twins) will be recruited at 1-4 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 three times (baseline, around 2 weeks and 4 weeks after the intervention) to evaluate milk production by hourly expression, to take milk samples for composition analysis and to assess baby's growth. 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).
Trial website
Trial related presentations / publications
Public notes
This trial will be the first study investigating the effect of yeast supplement on milk production and the safety of taking it while breastfeeding. Therefore, the findings will contribute to knowledge about the use of yeast as a galactagogue and the results will be communicated to both healthcare professionals and breastfeeding mothers.

Contacts
Principal investigator
Name 92986 0
Dr Janet Weber
Address 92986 0
School of Food and Advanced Technology
College of Science
Massey University
Private Bag 11 222
Palmerston North 4442
Country 92986 0
New Zealand
Phone 92986 0
+64 6 3569099 Ext.84562
Fax 92986 0
Email 92986 0
J.L.Weber@massey.ac.nz
Contact person for public queries
Name 92987 0
Dr Janet Weber
Address 92987 0
School of Food and Advanced Technology
College of Science
Massey University
Private Bag 11 222
Palmerston North 4442
Country 92987 0
New Zealand
Phone 92987 0
+64 6 3569099 Ext.84562
Fax 92987 0
Email 92987 0
J.L.Weber@massey.ac.nz
Contact person for scientific queries
Name 92988 0
Ms Lili Jia
Address 92988 0
School of Food and Advanced Technology
College of Science
Massey University
Private Bag 11 222
Palmerston North 4442
Country 92988 0
New Zealand
Phone 92988 0
+64 6 9516367
Fax 92988 0
Email 92988 0
l.jia@massey.ac.nz

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Confidentiality consideration and no ethics approval on sharing data with others.
What supporting documents are/will be available?
Study protocol
Ethical approval
How or where can supporting documents be obtained?
Type [1] 2006 0
Ethical approval
Citation [1] 2006 0
Link [1] 2006 0
Email [1] 2006 0
Other [1] 2006 0
Summary results
No Results