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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]

None

Universal Trial Number (UTN)

Trial acronym

MATSUB

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Breast milk composition

Condition category

Condition code

Diet and Nutrition

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]

Treatment: Other

Intervention code [2]

Lifestyle

Intervention code [3]

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]

Breast milk triglyceride concentrations

Timepoint [1]

Repeated measures at hourly intervals over 12 hours following consumption of the control or intervention diet.

Secondary outcome [1]

Breast milk lactose concentrations

Timepoint [1]

Repeated measures at hourly intervals over 12 hours following consumption of the control or intervention diet

Secondary outcome [2]

Breast milk protein concentrations

Timepoint [2]

Repeated measures at hourly intervals over 12 hours following consumption of the control or intervention diet

Secondary outcome [3]

Breast milk fatty acid composition

Timepoint [3]

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Funding & Sponsors

Funding source category [1]

University

Name [1]

School of Biosciences, University of Nottingham

Address [1]

Bonington Hall, Sutton Bonington, Loughborough LE12 5RD, United Kingdom

Country [1]

United Kingdom

Primary sponsor type

University

Name

University of Adelaide

Address

North Terrace, Adelaide, SA 5005

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

CSIRO Health and Medical Human Research Ethics Committee.

Ethics committee address [1]

CSIRO Human Research Ethics Committee
co/Rob McDowell
CSIRO Dutton Park
41 Boggo Rd, 
Dutton Park QLD 4102
Australia

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

24/03/2022

Ethics approval number [1]

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

A/Prof Beverly Muhlhausler

Address

CSIRO, Kintore Avenue, Adelaide, SA 5000

Country

Australia

Phone

+61 447360944

Fax

[email protected]

Contact person for public queries

Name

Ellen Ward

Address

CSIRO, Kintore Avenue, Adelaide, SA 5000

Country

Australia

Phone

+61 451488979

Fax

[email protected]

Contact person for scientific queries

Name

Ellen Ward

Address

CSIRO, Kintore Avenue, Adelaide, SA 5000

Country

Australia

Phone

+61 451488979

Fax

[email protected]

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

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.	Type	Citation	Link	Email	Other Details	Attachment
15784	Study 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.

Trial Review

Documents added manually

Documents added automatically