ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12618000613202

Ethics application status

Approved

Date submitted

10/04/2018

Date registered

19/04/2018

Date last updated

3/12/2019

Date data sharing statement initially provided

3/12/2019

Type of registration

Prospectively registered

Titles & IDs

Public title

The Diet and Breast Milk Composition Study

Scientific title

The short-term impact of consuming a breakfast meal containing high levels of fat or sugar in breastfeeding women on the concentrations of macronutrients and metabolic hormones in their breast milk over the subsequent 12 hours

Secondary ID [1]

Nil

Universal Trial Number (UTN)

U1111-1212-1377

Trial acronym

Linked study record

Health condition

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

Maternal Nutrition

Breastfeeding

Condition category

Condition code

Diet and Nutrition

Other diet and nutrition disorders

Reproductive Health and Childbirth

Breast feeding

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Breastmilk composition will be measured a regular intervals for the 12 hours following consumption of either a high-fat, high-sugar or control breakfast meal (all participants consume each breakfast at separate clinic sessions at least one week apart and in random order). The dietary interventions will be provided in the form of a specially designed breakfast meal which either aligns with the fat and sugar content consistent with the Australian Guide to Healthy Eating (AGHE) (control, 12g fat and 25g sugar) or contains higher levels of fat (high-fat, 28g fat) or higher levels of sugar (high-sugar, 57g sugar). The breakfast meal will be provided at ~7:30am after women have fasted from midnight on the previous day. Women will receive a text message/phone call to remind them of the need to fast on the day before the appointment and will be asked to confirm adherence to the fast at the start of their appointment. The breakfast meals will contain similar foods (cereal, milk, yogurt, toast and spread) and will be matched for total energy content as closely as possible.

Intervention code [1]

Lifestyle

Comparator / control treatment

A specially designed breakfast meal which either aligns with the fat and sugar content consistent with the Australian Guide to Healthy Eating (AGHE) (control, 12g fat and 25g sugar)

Control group

Active

Outcomes

Primary outcome [1]

Composite outcome of breast milk concentrations of metabolic hormones (leptin, insulin, adiponectin, ghrelin and Glucagon like peptide-1) in the 12 hours following consumption of either a control (designed in accordance with the Australian Guide to Healthy Eating (AGHE), high-fat or high-sugar breakfast.

Timepoint [1]

1, 2 [primary time point], 4, 6 and 12 hours following the breakfast meal (change in levels over time)

Secondary outcome [1]

Composite outcome of breast milk concentrations of macronutrients (fat, protein, lactose) in the 12 hours following consumption of either a control (AGHE), high-fat or high-sugar breakfast

Timepoint [1]

1, 2, 4, 6 and 12 hours following the breakfast meal (change in levels over time)

Eligibility

Key inclusion criteria

- Women who are currently breastfeeding
-Singleton pregnancy
- Term delivery
- Mothers between 6 weeks and 16 weeks post-partum at the time of the first study visit

Minimum age

18 Years

Maximum age

60 Years

Sex

Females

Can healthy volunteers participate?

Yes

Key exclusion criteria

- Known major congenital abnormalities or health issues in the infant that could significantly affect feeding behavior
- Complimentary feeding introduced before first study session
- Maternal diseases known to affect gastric absorption
- Maternal diabetes
- Restrictive diets (e.g. gluten free, dairy free, milk free, vegan)

Study design

Purpose of the study

Prevention

Allocation to intervention

Non-randomised trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

This study will be an open label crossover design in which all women will consume each of the different breakfast meals (high-fat, high-sugar and control breakfasts) in a random order. There will be a one-week wash-out period between the different breakfasts. Women will not know which breakfast they are receiving prior to arrival at their clinic session.

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 randomly 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

Phase

Not Applicable

Type of endpoint/s

Statistical methods / analysis

Recruitment

Recruitment status

Not yet recruiting

Date of first participant enrolment

Anticipated

2/03/2020

Actual

Date of last participant enrolment

Anticipated

31/07/2020

Actual

Date of last data collection

Anticipated

26/02/2021

Actual

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Recruitment hospital [1]

Womens and Childrens Hospital - North Adelaide

Recruitment postcode(s) [1]

5006 - North Adelaide

Funding & Sponsors

Funding source category [1]

University

Name [1]

The University of Adelaide

Address [1]

North Terrace
Adelaide
South Australia 5005

Country [1]

Australia

Primary sponsor type

University

Name

The University of Adelaide

Address

North Terrace
Adelaide
South Australia 5005

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Other collaborator category [1]

Other

Name [1]

South Australian Health and Medical Research Institute

Address [1]

North Terrace
Adelaide
South Australia 5001

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Women's and Children's Health Network

Ethics committee address [1]

Research Secretariat
WCHN
72 King William Road
North Adelaide  SA  5006

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

08/03/2018

Approval date [1]

22/03/2018

Ethics approval number [1]

HREC/17/WCHN/182

Summary

Brief summary

Breast milk is made up of nutrients including fat and sugar. It also contains hormones that help control how hungry or full we feel and how our body uses energy. When a mother breastfeeds, these hormones are transferred from the breast milk to the baby and may play a role in how baby grows and develops. We now know that what a mother eats while breastfeeding can affect how much breast milk she produces, but we still know very little about how this affects breast milk composition, including the levels of these hormones. 
The purpose of this study is to look at how consuming a breakfast meal containing different levels of fat and sugar affects the amounts of nutrients and other factors, including hormones in breast milk over the following 12 hours. This research will help us to understand the effect of different dietary choices during breastfeeding on the composition of the breast milk and, in the future, may help inform dietary guidelines for breastfeeding women.

Trial website

Trial related presentations / publications

Public notes

Attachments [1]

/AnzctrAttachments/374879-Clean_Diet and Breast Milk Composition Study Protocol V1.0 21.02.18.docx (Protocol)

Attachments [2]

/AnzctrAttachments/374879-Ethics_Approval_Diet_and_BM_composition_Study.pdf (Ethics approval)

Contacts

Principal investigator

Name

A/Prof Beverly Muhlhausler

Address

NHMRC Career Development Award Fellow
Head Food and Nutrition Group
Department of Food and Wine Sciences
School of Agriculture, Food and Wine
Waite Campus, The University of Adelaide
PMB 1, GLEN OSMOND, SA 5064

Country

Australia

Phone

+61 (0)402143949

Fax

beverly.muhlhausler@adelaide.edu.au

Contact person for public queries

Name

Beverly Muhlhausler

Address

Country

Australia

Phone

+61 (0)402143949

Fax

beverly.muhlhausler@adelaide.edu.au

Contact person for scientific queries

Name

Beverly Muhlhausler

Address

Country

Australia

Phone

+61 (0)402143949

Fax

beverly.muhlhausler@adelaide.edu.au

Data sharing statement

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

No/undecided IPD sharing reason/comment

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
5994	Study protocol					374879-(Uploaded-01-12-2019-18-06-01)-Study-related document.docx

Results publications and other study-related documents

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No additional documents have been identified.

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