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Trial registered on ANZCTR


Registration number
ACTRN12622000651785
Ethics application status
Approved
Date submitted
16/04/2022
Date registered
3/05/2022
Date last updated
3/05/2022
Date data sharing statement initially provided
3/05/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
The Impact of Sugar Intake on Breast Milk in Healthy Mothers.
Scientific title
Impact of Maternal Sugar Intake on Breast Milk Composition and Breast Milk Variation over 24 hours in Healthy Mothers.
Secondary ID [1] 306926 0
None
Universal Trial Number (UTN)
Trial acronym
MATSUB
Linked study record
NA

Health condition
Health condition(s) or problem(s) studied:
Breast milk composition 326031 0
Condition category
Condition code
Diet and Nutrition 323345 323345 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention diet will consist of a full days food consumption totalling to ~2500 calories and will include ~65g more sugar than the control diet. The foods provided consist of breakfast (cereal/toast/banana), lunch (pasta salad) and dinner (chicken stir-fry) plus two snacks (yogurt/fruit/crackers/cheese). The extra sugar will be incorporated in small changes such as adding sugar to cereal, honey on yogurt and a can of soda with lunch. The meals will be prepared and packed by the student investigator (SI) and delivered to participants homes ready for consumption.
The intervention will span one day (12 hours) and will occur once, at least a week apart from the control.
Adherence to the study diets will be monitored by weighing returned containers to estimate percentage consumption of meals and by using documentation designed to record extra details (e.g. consumed only half of dinner for X reason, consumed an orange at X time for X reason, consumed X amount of water at X time).
Intervention code [1] 323374 0
Treatment: Other
Intervention code [2] 323375 0
Lifestyle
Intervention code [3] 323458 0
Prevention
Comparator / control treatment
The control diet will consist of a full days food consumption totalling to ~2500 calories and will be designed to contain ~65g less sugar than the intervention diet. The foods provided consist of breakfast (cereal/toast/banana), lunch (pasta salad) and dinner (chicken stir-fry) plus two snacks (yogurt/fruit/crackers/cheese). The meals will be prepared and packed by the student investigator (SI) and delivered to participants homes ready for consumption.
The control will span one day (12 hours) and will occur once, at least a week apart from the intervention.
Adherence to the study diets will be monitored by weighing returned containers to estimate percentage consumption of meals and by using documentation designed to record extra details (e.g. consumed only half of dinner for X reason, consumed an orange at X time for X reason, consumed X amount of water at X time).
Control group
Active

Outcomes
Primary outcome [1] 331078 0
Breast milk triglyceride concentrations
Timepoint [1] 331078 0
Repeated measures at hourly intervals over 12 hours following consumption of the control or intervention diet.
Secondary outcome [1] 408651 0
Breast milk lactose concentrations
Timepoint [1] 408651 0
Repeated measures at hourly intervals over 12 hours following consumption of the control or intervention diet
Secondary outcome [2] 408652 0
Breast milk protein concentrations
Timepoint [2] 408652 0
Repeated measures at hourly intervals over 12 hours following consumption of the control or intervention diet
Secondary outcome [3] 408653 0
Breast milk fatty acid composition
Timepoint [3] 408653 0
Repeated measures at hourly intervals over 12 hours following consumption of the control or intervention diet

Eligibility
Key inclusion criteria
• Healthy mothers and singleton infants born at full term (>38 weeks gestation)
• Mothers between the ages of 21-35 years
• Mothers with a BMI between 20 and 30 kg/m2
• Infants between 6 and 20 weeks of age at the time of recruitment
• Mother and infants have no self-reported underlying medical conditions/special dietary requirements which result in restriction of any major food groups (e.g. vegan/dairy allergy)
• Mother able to give informed consent for themselves and their infants
• Mothers have been exclusively breastfeeding (with the exception of additional water or medication such as paracetamol suspensions) their infant since birth
Minimum age
21 Years
Maximum age
35 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
• Infants who were born by caesarean section
• Infants who are fed formula milk or fed a mixture of breast milk and formula
• Mothers who are struggling with breast feeding and/or are unable to manually express milk.
• Mother and/or baby who has an allergy/intolerance/aversion to the study diet (e.g. lactose intolerance).

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The order in which women will receive breakfast meals will be randomly generated, and not determined by either the participant or investigator ahead of the random allocation
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The order in which women receive the breakfast meals will be determined using a computer program and by an individual who is not involved in recruitment or sample collection.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Women will complete both arms of the study (control and intervention diet) in a random order
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Will be conducted according to a pre-defined statistical plan (to be finalised). The data will be analysed using repeated measures ANOVAs, paired t-tests and mixed models as appropriate.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
6/05/2022
Actual
Date of last participant enrolment
Anticipated
4/07/2022
Actual
Date of last data collection
Anticipated
29/07/2022
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 311245 0
University
Name [1] 311245 0
School of Biosciences, University of Nottingham
Country [1] 311245 0
United Kingdom
Primary sponsor type
University
Name
University of Adelaide
Address
North Terrace, Adelaide, SA 5005
Country
Australia
Secondary sponsor category [1] 312604 0
None
Name [1] 312604 0
Address [1] 312604 0
Country [1] 312604 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310758 0
CSIRO Health and Medical Human Research Ethics Committee.
Ethics committee address [1] 310758 0
CSIRO Human Research Ethics Committee
co/Rob McDowell
CSIRO Dutton Park
41 Boggo Rd,
Dutton Park QLD 4102
Australia
Ethics committee country [1] 310758 0
Australia
Date submitted for ethics approval [1] 310758 0
Approval date [1] 310758 0
24/03/2022
Ethics approval number [1] 310758 0

Summary
Brief summary
The aim of this study is to determine the effect of increased sugar consumption on the composition of breast milk and to assess variations in breast milk composition across the day. The intervention within this study includes two different diets; one control and one higher in sugar. A cross-over design will be used where control and higher sugar diets will be provided in a random order to each woman across two days. Women will be asked to manually express small amounts of breast milk each hour throughout the day (alongside consumption of the provided diets). Breast milk will be analysed for triglyceride, lactose, protein and fatty acid concentrations.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 118766 0
A/Prof Beverly Muhlhausler
Address 118766 0
CSIRO, Kintore Avenue, Adelaide, SA 5000
Country 118766 0
Australia
Phone 118766 0
+61 447360944
Fax 118766 0
Email 118766 0
bev.muhlhausler@csiro.au
Contact person for public queries
Name 118767 0
Miss Ellen Ward
Address 118767 0
CSIRO, Kintore Avenue, Adelaide, SA 5000
Country 118767 0
Australia
Phone 118767 0
+61 451488979
Fax 118767 0
Email 118767 0
ellen.ward@csiro.au
Contact person for scientific queries
Name 118768 0
Miss Ellen Ward
Address 118768 0
CSIRO, Kintore Avenue, Adelaide, SA 5000
Country 118768 0
Australia
Phone 118768 0
+61 451488979
Fax 118768 0
Email 118768 0
ellen.ward@csiro.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
At this stage, individual data sharing is not planned, due to potential privacy concerns, however he sharing of IPD will be reviewed at the completion of the study, depending on the outcomes and determination of a way to share in a deidentified way.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
15784Study protocol    Attachment 383927-(Uploaded-13-04-2022-10-15-54)-Study-related document.pdf



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.