Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619000606189
Ethics application status
Approved
Date submitted
1/04/2019
Date registered
23/04/2019
Date last updated
23/04/2019
Date data sharing statement initially provided
23/04/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Assessing the effect of changing a women's diet during breastfeeding on the levels of nutrients and hormones in their breast milk.
Scientific title
Assessing the effect of a short-term dietary intervention on human milk composition.

Secondary ID [1] 297705 0
Nil known
Universal Trial Number (UTN)
U1111 - 1229 - 9784
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breastfeeding 312011 0
Condition category
Condition code
Reproductive Health and Childbirth 310578 310578 0 0
Breast feeding
Metabolic and Endocrine 310579 310579 0 0
Normal metabolism and endocrine development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The study will be conducted over 3 weeks. Participants will complete three 24 h dietary recalls (2 week and 1 weekend days) for 1 week before the dietary intervention using the Automated Self-Administered 24-Hour Dietary Recall (ASA24). Habitual macronutrient intakes of the women will be assessed using this information. Following this baseline week, the 2-week dietary intervention phase will commence. The intervention will be targeted towards women interested in improving their dietary quality, and will focus on reducing fat and sugar intake.
The 2-week dietary intervention phase includes:
1. Participants consuming 7500kJ full day menu from Lite n' Easy, and additional snacks (~2000kJ per day) to meet energy requirements during lactation.
The Lite n' Easy diets used during this period are focused on reducing intakes of discretionary foods, saturated fats and added sugars in comparison to the women’s habitual diet.
2. Food choices will cater to individual tastes and any allergies/food intolerances.
All foods/snacks will be provided to women (via a home delivery service) to facilitate compliance.
3. Example of Lite n' Easy full day menu:
Breakfast
Option 1 - Nut cluster crunch with skim milk, 2 slices of wholemeal and seed toast with butter and vegemite.
Morning snack - Peaches with raspberry sauce
Option 2 - Baked beans, egg and cheese on 2 slices of multigrain toast.
Morning Snack - Kiwi fruit

Lunch
Option 1 - Roasted vegetables and chicken salad with garlic and lemon vinegarette and a red apple
Afternoon snack - Sweet corn fritters with tomato jam
Option 2 - Tasmanian salmon risotto and peach cup
Afternoon snack - Passionfruit yoghurt and maple coconut crunch with cranberries.

Dinner - Range of dinner options to choose from, for exmaple: Roast chicken breast in mushroom sauce, served with seasonal vegetables and potato wedges, spaghetti marinara made with Australian salmon, prawns and calamari in a tomato Napoli sauce.

4. Participants will be asked to record any foods/drinks they consume other than those provided.
Intervention code [1] 313938 0
Treatment: Other
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 319431 0
Human milk concentration of macronutrient protein following a two week dietary intervention aimed at reducing fat and sugar intakes. Milk samples (5 mL) will be collected each morning (before the first morning feed) for each day of the study. In total 21 samples will be collected.
Timepoint [1] 319431 0
Pre intervention diet (baseline, up to 7 days before) and post (at day 14 of intervention diet, primary endpoint). Comparisons will also be made at day 7.
Primary outcome [2] 319726 0
Human milk concentration of macronutrient fat following a two week dietary intervention aimed at reducing fat and sugar intakes. Milk samples (5 mL) will be collected each morning (before the first morning feed) for each day of the study. In total 21 samples will be collected.
Timepoint [2] 319726 0
Pre intervention diet (baseline, up to 7 days before) and post (at day 14 of intervention diet, primary endpoint). Comparisons will also be made at day 7.
Primary outcome [3] 319727 0
Human milk concentration of macronutrient lactose following a two week dietary intervention aimed at reducing fat and sugar intakes. Milk samples (5 mL) will be collected each morning (before the first morning feed) for each day of the study. In total 21 samples will be collected.
Timepoint [3] 319727 0
Pre intervention diet (baseline, up to 7 days before) and post (at day 14 of intervention diet, primary endpoint). Comparisons will also be made at day 7.
Secondary outcome [1] 368159 0
Human milk concentration of metabolic hormone ghrelin following a two week dietary intervention aimed at reducing maternal fat and sugar intakes. Milk samples (5 mL) will be collected each morning (before the first morning feed) for each day of the study. In total 21 samples will be collected.
Timepoint [1] 368159 0
Pre intervention diet (up to 7 days before) and post (at day 7 and 14 of intervention diet).
Secondary outcome [2] 368724 0
Variability of fat content across 24 hours. Several milk samples will be collected in one 24 hr period in each week of the intervention. Pre feed samples will be taken as women are often unable to express this volume after feeding.
Timepoint [2] 368724 0
Collecting 3 milk samples - from one feed in morning, one in the afternoon and one in the evening for one 24 hr period in each week of the intervention.
Secondary outcome [3] 368730 0
Maternal weight (calibrated electronic scales, to 0.1kg) will be assessed to determine whether following the prescribed diet has any effect on mothers weight,
Timepoint [3] 368730 0
Measurements will be taken during the observation week and then at the completion of the 2 week intervention.
Secondary outcome [4] 368731 0
Infant weight (calibrated electronic scales, to 0.01kg) will be assessed to monitor the growth of the infant for the study duration.
Timepoint [4] 368731 0
Measurements will be taken during the observation week and then at the completion of the 2 week intervention.
Secondary outcome [5] 368732 0
Maternal gut microbiome will be analysed to determine whether changes in maternal dietary intake change the bacterial component in mother. This will be assessed using a stool sample which will be collected by the mother using an Eswab collection pack.
Timepoint [5] 368732 0
Sample collected on one day per week for each week of the study (3 maternal samples in total).
Secondary outcome [6] 368745 0
We will analyse a panel of cytokines and chemokines reflective of maternal immune status. This is an exploratory outcome.
Timepoint [6] 368745 0
Pre intervention diet (up to 7 days before) and post (at day 7 and 14 of intervention diet).
Secondary outcome [7] 368905 0
We will explore if any significant changes in human milk antioxidants occur as a result of the dietary intervention. This will be an exploratory outcome.
Timepoint [7] 368905 0
Pre intervention diet (up to 7 days before) and post (at day 7 and 14 of intervention diet).
Secondary outcome [8] 369297 0
Infant gut microbiome will be analysed to determine whether changes in maternal dietary intake change the bacterial component in the infant's gut. This will be assessed using a stool sample taken from the infants nappy, by the mother using an Eswab collection pack.
Timepoint [8] 369297 0
Sample collected on one day per week for each week of the study (3 samples in total).
Secondary outcome [9] 369303 0
Infant length (length board, to 0.1cm) will be assessed to monitor the growth of the infant for the study duration.
Timepoint [9] 369303 0
Measurements will be taken during the observation week and then at the completion of the 2 week intervention.
Secondary outcome [10] 369304 0
Infant head circumference (non-stretch tape, to 0.1cm) will be assessed to monitor the growth of the infant for the study duration.
Timepoint [10] 369304 0
Measurements will be taken during the observation week and then at the completion of the 2 week intervention.
Secondary outcome [11] 369305 0
Infant body composition (Bioimpedance Spectroscopy; Impedimed SFB-7) will be assessed to monitor the growth of the infant for the study duration.
Timepoint [11] 369305 0
Measurements will be taken during the observation week and then at the completion of the 2 week intervention.
Secondary outcome [12] 369306 0
Maternal height (Stadiometer to 0.01m) and body composition (Bioimpedance Spectroscopy; Impedimed SFB-7) will be assessed to determine whether following the prescribed diet has any effect on mothers weight, Height measurement is required to calculate body composition.
Timepoint [12] 369306 0
Measurements will be taken during the observation week and then at the completion of the 2 week intervention.
Secondary outcome [13] 369307 0
Human milk concentration of metabolic hormone leptin, following a two week dietary intervention aimed at reducing maternal fat and sugar intakes. Milk samples (5 mL) will be collected each morning (before the first morning feed) for each day of the study. In total 21 samples will be collected.
Timepoint [13] 369307 0
Pre intervention diet (up to 7 days before) and post (at day 7 and 14 of intervention diet).
Secondary outcome [14] 369308 0
Human milk concentration of metabolic hormone insulin, following a two week dietary intervention aimed at reducing maternal fat and sugar intakes. Milk samples (5 mL) will be collected each morning (before the first morning feed) for each day of the study. In total 21 samples will be collected.
Timepoint [14] 369308 0
Pre intervention diet (up to 7 days before) and post (at day 7 and 14 of intervention diet).
Secondary outcome [15] 369309 0
Human milk concentration of metabolic hormone adiponectin following a two week dietary intervention aimed at reducing maternal fat and sugar intakes. Milk samples (5 mL) will be collected each morning (before the first morning feed) for each day of the study. In total 21 samples will be collected.
Timepoint [15] 369309 0
Pre intervention diet (up to 7 days before) and post (at day 7 and 14 of intervention diet).

Eligibility
Key inclusion criteria
- Singleton pregnancy
- Term delivery
- Women who are currently breastfeeding
- Mothers between 6 weeks and 12 weeks post-partum at the time of the first study visit
- Infants should be growing normally (<90th percentile according to WHO standards).
- Mother able to give written informed consent for herself and her infant.
Minimum age
6 Weeks
Maximum age
50 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Known major congenital abnormalities or health issues in the infant that could significantly affect feeding behavior
- Pregnancy complications (e.g. Gestational Diabetes Mellitus, preeclampsia, fetal growth restriction)
- Pre-term infants
- Complementary feeding introduced before first study session
- Maternal diseases known to affect gastric absorption
- Maternal diabetes
- Restrictive diets (e.g. gluten free, dairy free, vegan)

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Based on previously published data from CI Geddes, a sample size of 48 will give us 80% power to detect a 17% reduction in protein (mean diff= 2.2, SD=6.15), 4.8% reduction in fat (mean diff=2.97, SD=7.8), 11% reduction in leptin (mean diff=0.06, SD=11.5) and 12% reduction in adiponectin concentrations (mean diff=1.57, SD=4.39). The longitudinal profile of concentrations of the various components across the study period will also be examined.

The change in breast milk concentrations of each individual macronutrient and hormone will be assessed using repeated measures analyses of variance. The area under the concentration curve will be calculated to determine the total change in levels of each hormone/macronutrient across the weeks. The pattern of change and total change in the level of each hormone/macronutrient across the 3-week period will be assessed using a repeated measures 2-way ANOVA and paired t-test respectively.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
29/04/2019
Actual
Date of last participant enrolment
Anticipated
29/04/2021
Actual
Date of last data collection
Anticipated
27/05/2021
Actual
Sample size
Target
48
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 302229 0
University
Name [1] 302229 0
The University of Western Australia
Country [1] 302229 0
Australia
Primary sponsor type
Individual
Name
A/Prof Donna Geddes
Address
The University of Western Australia
M310, 35 Stirling Highway
Crawley WA 6009
Country
Australia
Secondary sponsor category [1] 302269 0
None
Name [1] 302269 0
Address [1] 302269 0
Country [1] 302269 0
Other collaborator category [1] 280620 0
Individual
Name [1] 280620 0
Professor Mary Wlodek
Address [1] 280620 0
Fetal, postnatal & adult physiology and disease laboratory, Department of Physiology,
School of Biomedical Sciences,
The University of Melbourne,
Parkville, Victoria, Australia 3010
Country [1] 280620 0
Australia
Other collaborator category [2] 280621 0
Individual
Name [2] 280621 0
A/Prof Bev Muhlhausler
Address [2] 280621 0
Research Director - Nutrition and Health
CSIRO
Health and Biosecurity
Kintore Avenue
Adelaide
SA 5000
Country [2] 280621 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302909 0
The University of Western Australia Human Research Ethics Committee
Ethics committee address [1] 302909 0
Ethics committee country [1] 302909 0
Australia
Date submitted for ethics approval [1] 302909 0
17/10/2018
Approval date [1] 302909 0
04/12/2018
Ethics approval number [1] 302909 0
RA/4/204953

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 91810 0
A/Prof Donna Geddes
Address 91810 0
School of Molecular Sciences
The University of Western Australia
M310, 35 Stirling Highway
Crawley WA 6009
Country 91810 0
Australia
Phone 91810 0
+61 ,8,64887006
Fax 91810 0
+61,8,64887086
Email 91810 0
[email protected]
Contact person for public queries
Name 91811 0
Kirsty O'Hehir
Address 91811 0
School of Molecular Sciences
The University of Western Australia
M310, 35 Stirling Highway
Crawley WA 6009
Country 91811 0
Australia
Phone 91811 0
+61 ,8,64883144
Fax 91811 0
+61,8,64887086
Email 91811 0
[email protected]
Contact person for scientific queries
Name 91812 0
Donna Geddes
Address 91812 0
School of Molecular Sciences
The University of Western Australia
M310, 35 Stirling Highway
Crawley WA 6009
Country 91812 0
Australia
Phone 91812 0
+61 ,8,64887006
Fax 91812 0
+61,8,64887086
Email 91812 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
After de-identification; individual participant data underlying published results only
When will data be available (start and end dates)?
Immediately following publication, for 5 years.
Available to whom?
Anyone who wishes to access it via a publicly accessible data registry.
Available for what types of analyses?
To achieve the aims in the approved proposal.
How or where can data be obtained?
Proposals should be directed to [email protected]
To gain access, data requestors will need to sign a data access agreement. Data are available for 5 years at a third party website.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseReduction in maternal energy intake during lactation decreased maternal body weight and concentrations of leptin, insulin and adiponectin in human milk without affecting milk production, milk macronutrient composition or infant growth.2021https://dx.doi.org/10.3390/nu13061892
EmbaseEffect of a reduced fat and sugar maternal dietary intervention during lactation on the infant gut microbiome.2022https://dx.doi.org/10.3389/fmicb.2022.900702
N.B. These documents automatically identified may not have been verified by the study sponsor.