None listed
Conditions
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).
Interventions
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
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.
Sponsors
Edith Cowan University
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
4 Years to 6 Years
Healthy volunteers
Yes
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).
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.
Outcome results
None listed