Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616001642471
Ethics application status
Approved
Date submitted
8/11/2016
Date registered
28/11/2016
Date last updated
22/01/2020
Date data sharing statement initially provided
22/01/2020
Date results information initially provided
22/01/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
The Milky Way Study: Comparing effects of regular fat vs reduced fat dairy products on heart and gut health in young children
Scientific title
Regular fat versus reduced fat dairy consumption: a pilot study of effects on cardiometabolic and gut health in young children
Secondary ID [1] 290492 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
adiposity 300878 0
gut health and microbiome 300879 0
cardiometabolic health 300880 0
Condition category
Condition code
Diet and Nutrition 300698 300698 0 0
Other diet and nutrition disorders
Diet and Nutrition 300699 300699 0 0
Obesity
Cardiovascular 300879 300879 0 0
Normal development and function of the cardiovascular system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This randomized controlled double blind trial aims to investigate the effects of regular fat compared with reduced fat dairy intake on children’s adiposity, heart health and gut health.
The three month intervention will involve fortnightly delivery of plain packaged dairy products (tailored to suit the child’s normal intake) that will either be regular fat or reduced fat. Assessments will be conducted at the start and end of the intervention period.

For the intervention, participants will be provided with either regular or reduced fat dairy. For the purposes of this research, dairy can include milk, cheese, yoghurt, custard, cream, sour cream, dairy dessert, and butter. Products provided will be matched to what the child would normally eat, as determined by a dietitian administered diet history with the child's parent/caregiver. The diet history in conjunction with a 3 day weighed food record will also be used to assess baseline diet. Parents will be asked to use the study products provided in place of the normal products they would use in the home. If children are eating food supplied away from home the can still do this as usual, they do not need to avoid other dairy.

Our team has previously tested a range of different dairy products with a convenience sample of 8 children to determine acceptability; only products deemed to have an acceptability score of 3 or more will be included in this study. Acceptability was tested using a Likert ‘smiley face’ scale of 1-5, with 1 representing very yucky/unacceptable to 5 very yummy/acceptable. The information below outlines the types of dairy product that will be provided as part of the proposed study.

The regular fat dairy group: Children will receive regular fat dairy products, in accordance with existing dietary guidelines and their own preferences, to consume as part of their normal diet. Fat values of these products will be approximately 4g/100ml for milk, 35g/100g for cheese, 9g/100 g for yoghurt, and 4g/100g for dairy dessert/custard. Caregivers will be instructed to replace existing dairy products with the products supplied. No dosages will be recommended, with dairy product consumption and other general dietary behaviours to occur as per usual.

The reduced fat dairy group: Children will receive reduced fat dairy products, in accordance with existing dietary guidelines and their own preferences, to consume as part of their normal diet. Fat values of these products will be approximately 2g/100 ml for milk, 15g/100g for cheese, 2g/100 g for yoghurt, and 2g/100g for dairy dessert/custard. As with regular fat group, no dosages will be recommended, with dairy consumption, and other general dietary behaviours to continue as per usual.

We will conduct fortnightly phone calls with parents/carers to assess compliance with the study protocols. This assessment will provide an opportunity to check if parents/carers are happy to remain in the study with their children, if they would like to change the type and/or amount of dairy currently being delivered and to note any issues arising in the preceding two weeks. If the child is deviating from their usual intake and not consuming at least one serve of dairy per day for the fortnight from sources provided, encouragement and support will be provided, including recipe ideas and changes to the types of products supplied if required. The family will be contacted on a weekly basis to monitor progress. If a child is not consuming at least 70% of their dairy from the products supplied for four weeks, this will be noted as non-compliant in our reporting data, and modelled according to intention-to-treat principles.
Intervention code [1] 296350 0
Lifestyle
Comparator / control treatment
Active control: consumption of mostly reduced fat dairy products (current standard care/dietary guidelines: NHMRC's Australian Dietary Guidelines 2013)
Reduced fat products: pproximately 2g/100 ml for milk, 15g/100g for cheese, 2g/100 g for yoghurt, and 2g/100g for dairy dessert/custard
Control group
Active

Outcomes
Primary outcome [1] 300116 0
Adiposity: assessed using anthropometrics and body composition. A COSMED BODPOD with paediatric option will be used to measure body composition.
Timepoint [1] 300116 0
At baseline assessment and after intervention completion (3 months post baseline)
Primary outcome [2] 300117 0
Gut microbiota, assessed using 48-hour stool samples (DNA analysis of bacteria, short chain fatty acid analysis).
Timepoint [2] 300117 0
At baseline assessment and after intervention completion (3 months post baseline); plus after going back to usual diet (6 months post baseline).
Primary outcome [3] 300118 0
Cardiometabolic health (cholesterol, inflammation, triglycerides, insulin resistance), assessed using serum samples, blood pressure assessed using Dinamap recorder with paediatric cuff.
Timepoint [3] 300118 0
At baseline assessment and after intervention completion (3 months post baseline)
Secondary outcome [1] 329097 0
Food group intake as determined by 3 day weighed food record.
Timepoint [1] 329097 0
At baseline assessment and after intervention completion (3 months post baseline); plus after going back to usual diet (6 months post baseline).
Secondary outcome [2] 329098 0
Evaluation of child-centred research procedures using parent and child survey (survey designed specifically for this study)
Timepoint [2] 329098 0
At each clinic visit (baseline assessment and intervention end)
Secondary outcome [3] 329099 0
Biomarkers of dairy intake pentadecanoic acid (15:0), heptadecanoic acid (17:0), trans-palmitoleic acid (C16:1, n-7) plus erythrocyte fatty acid Omega-3, analysed by gas chromatography on an Agilent 7890A gas chromatograph (Santa Clara, CA).
Timepoint [3] 329099 0
At baseline assessment and after intervention completion (3 months post baseline)
Secondary outcome [4] 329100 0
Body strength, assessed by isometric mid-thigh pull on a force platform.
Timepoint [4] 329100 0
At baseline assessment and after intervention completion (3 months post baseline)

Eligibility
Key inclusion criteria
1. Boys and girls aged four to six, inclusive, at beginning of study
2. Consume at least one serve of dairy per day (e.g. 40g cheese, 250 ml milk, 200g yoghurt)
3. Have more than 70% (5 of 7 days) of their dairy either consumed at home or prepared at home
4. Willing to complete three x 3-day food records
5. Willing to provide blood (twice) and stool samples (three times)
6. Willing to attend three clinical visits at Joondalup ECU
7. Not participating in any other studies which may influence the outcome variables of this study
8. If probiotics are being taken, stable probiotic use over the duration of study (defined as keeping the same intake amount and type of probiotic over the study period between baseline and final assessments).
Minimum age
4 Years
Maximum age
6 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Children will be ineligible to participate if they:
1. Are lactose intolerant
2. Are allergic to cow’s milk protein e.g. dairy products
3. Have taken antibiotics within the last six months (may be reduced to three months depending on ease of recruitment)
4. Have any digestive disorder which may affect nutrient absorption and gastrointestinal motility such as Coeliac disease, Irritable Bowel Disease/Disorder, ulcerative colitis or Crohn’s Disease
5. Have a history of regular intestinal discomfort (e.g. diarrhoea, constipation once a week or more frequently);
6. Have had any surgery involving the gastro-intestinal tract
7. Have diabetes or diagnosed metabolic syndrome
8. Are taking any medication that will significantly alter the measurements of the primary outcome variables, including anti-hypertensives or lipid-lowering medications
9. Have or have had any cardiovascular events or diagnosed cardiovascular disease or metabolic disease
10. Have a body weight lower than 9.5 kg.

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)
Sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Children will be randomised into two groups using block randomisation, stratified by gender.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
This two-tailed power analysis has been based on a total number of 40 children, although the total number we are aiming for is 55. This is because it is likely that some children will not participate in all aspects of the study (for example, it may not be possible to get a blood sample from some children). Assumptions about distribution of measurements have been based on previous research in children by Fields and Allison (2012) and Eisenmann, Heelan, and Welk (2004) (for body fat), and from Juhola et al. (2011) and Burke et al. (2005) (for LDL- and HDL-cholesterol). We estimate that this study will have the following power to detect differences between the change in the regular fat dairy group and the change in the reduced fat dairy group:

-Body fat: 80% power to detect a change of above or equal to 3.3%, or 50% power to detect above or equal to 2%.
-LDL-cholesterol: 80% power to detect a change of above or equal to 0.73 mmol/L, or 50% power to detect above or equal to 0.51 mmol/L.
-HDL-cholesterol: 80% power to detect a change of above or equal to 0.27 mmol/L, or 50% power to detect a above or equal to 0.19 mmol/L.

These values are considered to be clinically relevant in this age group. As the study is a pilot test, and our objectives include to determine the feasibility of the methodology and to provide information for planning a full-scale trial, the study is modestly powered to detect the magnitude of change that would realistically be expected to occur over a 3-month period. However, it will provide sufficient data on which to base the study design for a full scale trial with high power to better detect change.

We will perform between group (regular fat dairy vs reduced fat dairy) comparisons for change in each of the main study measures over the period of the study. Differences between the two groups will be tested using Student t-tests or the Mann-Whitney U test if data do not meet the assumptions for parametric tests and cannot be normalized by using a logarithmic or similar transformation. Values will be standardized where appropriate to allow for age-related changes. Where transformed variables have a normal distribution, repeated measures ANOVA will be used to test for between group differences adjusting for baseline values and age of child at baseline. A significance threshold of 0.05 will be used. The researchers will also use the R package ‘vegan’, a common ecological package, to measure similarity and dissimilarity between the samples (Oksanen et al., 2007).

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/12/2016
Actual
27/01/2017
Date of last participant enrolment
Anticipated
Actual
25/09/2017
Date of last data collection
Anticipated
31/03/2018
Actual
26/03/2018
Sample size
Target
55
Accrual to date
Final
49
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 294907 0
Government body
Name [1] 294907 0
Telethon Perth Childrens Hospital Research Fund (Department of Health, WA)
Country [1] 294907 0
Australia
Funding source category [2] 294908 0
Other Collaborative groups
Name [2] 294908 0
Telethon Kids Institute
Country [2] 294908 0
Australia
Primary sponsor type
University
Name
Edith Cowan University
Address
270 Joondalup Drive
Joondalup WA 6027
Country
Australia
Secondary sponsor category [1] 293744 0
Other Collaborative groups
Name [1] 293744 0
Telethon Kids Institute
Address [1] 293744 0
PO Box 855
West Perth Western Australia 6872
Australia
Country [1] 293744 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296288 0
Edith Cowan University
Ethics committee address [1] 296288 0
Office of Research & Innovation,Edith Cowan University,
270 Joondalup Drive, Joondalup, WA 6027
Ethics committee country [1] 296288 0
Australia
Date submitted for ethics approval [1] 296288 0
Approval date [1] 296288 0
04/11/2016
Ethics approval number [1] 296288 0
14990

Summary
Brief summary
This project is a randomised controlled double-blind trial. It will involve recruiting 55 children aged 4-6 years, who normally consume dairy products on a regular basis. The three month intervention will involve fortnightly delivery of plain packaged dairy products, either reduced fat or regular fat, tailored to suit the child’s normal intake. Assessments conducted at the start and end of the intervention period will include body composition assessment using a BOD POD; blood analysis of lipids, insulin resistance, inflammation and fatty acid biomarkers; blood pressure; strength testing; diet assessment, and gut health using faecal samples. The project will also include a follow up collection point three months after the completion of the intervention. At this time point only a 3-day food record and set of faecal samples will be collected. This project will provide proof of concept for a similar project on a large scale. The study procedures have been informed by preceding focus group research in a convenience sample of parents of young children (manuscript in preparation).
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 70270 0
Dr Therese O'Sullivan
Address 70270 0
Department of Nutrition and Dietetics,
Edith Cowan University,
270 Joondalup Drive, Joondalup, WA 6027
Country 70270 0
Australia
Phone 70270 0
+618 63043529
Fax 70270 0
Email 70270 0
[email protected]
Contact person for public queries
Name 70271 0
Dr Therese O'Sullivan
Address 70271 0
Department of Nutrition and Dietetics,
Edith Cowan University,
270 Joondalup Drive, Joondalup, WA 6027
Country 70271 0
Australia
Phone 70271 0
+618 63043529
Fax 70271 0
Email 70271 0
[email protected]
Contact person for scientific queries
Name 70272 0
Dr Therese O'Sullivan
Address 70272 0
Department of Nutrition and Dietetics,
Edith Cowan University,
270 Joondalup Drive, Joondalup, WA 6027
Country 70272 0
Australia
Phone 70272 0
+618 63043529
Fax 70272 0
Email 70272 0
[email protected]

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?

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
EmbaseWhole-fat dairy products do not adversely affect adiposity or cardiometabolic risk factors in children in the Milky Way Study: A double-blind randomized controlled pilot study.2021https://dx.doi.org/10.1093/ajcn/nqab288
N.B. These documents automatically identified may not have been verified by the study sponsor.