Trial Review

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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] 294556 0
Nil
Universal Trial Number (UTN)
U1111-1212-1377
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Maternal Nutrition 307333 0
Breastfeeding 307334 0
Condition category
Condition code
Diet and Nutrition 306443 306443 0 0
Other diet and nutrition disorders
Reproductive Health and Childbirth 306551 306551 0 0
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] 300851 0
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] 305454 0
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] 305454 0
1, 2 [primary time point], 4, 6 and 12 hours following the breakfast meal (change in levels over time)
Secondary outcome [1] 345286 0
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] 345286 0
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
25
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 10615 0
Womens and Childrens Hospital - North Adelaide
Recruitment postcode(s) [1] 22332 0
5006 - North Adelaide

Funding & Sponsors
Funding source category [1] 299179 0
University
Name [1] 299179 0
The University of Adelaide
Country [1] 299179 0
Australia
Primary sponsor type
University
Name
The University of Adelaide
Address
North Terrace
Adelaide
South Australia 5005
Country
Australia
Secondary sponsor category [1] 298440 0
None
Name [1] 298440 0
Address [1] 298440 0
Country [1] 298440 0
Other collaborator category [1] 280054 0
Other
Name [1] 280054 0
South Australian Health and Medical Research Institute
Address [1] 280054 0
North Terrace
Adelaide
South Australia 5001
Country [1] 280054 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300103 0
Women's and Children's Health Network
Ethics committee address [1] 300103 0
Ethics committee country [1] 300103 0
Australia
Date submitted for ethics approval [1] 300103 0
08/03/2018
Approval date [1] 300103 0
22/03/2018
Ethics approval number [1] 300103 0
HREC/17/WCHN/182

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 2583 2583 0 0
/AnzctrAttachments/374879-Clean_Diet and Breast Milk Composition Study Protocol V1.0 21.02.18.docx (Protocol)
Attachments [2] 2584 2584 0 0
/AnzctrAttachments/374879-Ethics_Approval_Diet_and_BM_composition_Study.pdf (Ethics approval)

Contacts
Principal investigator
Name 82574 0
A/Prof Beverly Muhlhausler
Address 82574 0
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 82574 0
Australia
Phone 82574 0
+61 (0)402143949
Fax 82574 0
Email 82574 0
[email protected]
Contact person for public queries
Name 82575 0
Beverly Muhlhausler
Address 82575 0
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 82575 0
Australia
Phone 82575 0
+61 (0)402143949
Fax 82575 0
Email 82575 0
[email protected]
Contact person for scientific queries
Name 82576 0
Beverly Muhlhausler
Address 82576 0
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 82576 0
Australia
Phone 82576 0
+61 (0)402143949
Fax 82576 0
Email 82576 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
5994Study protocol    374879-(Uploaded-01-12-2019-18-06-01)-Study-related document.docx



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.