None listed
Conditions
Brief summary
Study Aims To determine if consuming Growing up milk ‘lite’ (GUMLi) compared to standard cow’s milk improves nutritional status, cognitive development and body composition profile (and health outcomes) in 1-2 year olds. Specific Objectives 1. To recruit an ethnically diverse sample of children aged prior to 1 year of age; 2. Randomise children to receive GUMLi or cow’s milk and retain children in study on intervention for 12 months from 1 year of age (+/- 4 weeks); 3. Measure anthropometry, biomarkers of macro- and micro- nutrient status, cognitive functioning, and dietary intake from 1 (+/- 4 weeks) year of age to 2 (+/- 4 weeks) years of age Study hypotheses 1. Children who consume GUMLi from age 1-2 years have a linear growth rate that is similar to children who consume cow’s milk from age 1-2 years and a % body fat increase that is less than children who consume cow’s milk from age 1-2 years. 2. Children who consume GUMLi from age 1-2 years compared to children who consume cow’s milk from age 1-2 years will be less likely to have vitamin D and iron insufficiency as defined by measurement of relevant serum biomarkers. 3. Children who consume GUMLi from age 1-2 years will have improved dietary profiles in comparison to children who consume cow’s milk from 1-2 years. 4. Children who consume GUMLi milk from age 1-2 years will have better developmental scores on the Bayley’s Scales of Infants Development in comparison to children who consume cow’s milk from 1-2 years.
Interventions
The children will be randomised into two groups, to receive either GUMLi or homogenised cow’s milk and will be followed for 12 months. The Growing Up Milk - "lite" is a toddler milk similar in composition to a commercially available toddler milk, but with reduced energy.
Intervention: Growing Up Milk Lite
Dose: 2 * 150ml of formula per day for a total of 12 months (from when the child turns 1 year of age until they turn 2 years of age).
The Growing Up Milk is lower in energy than cow's m
The children will be randomised into two groups, to receive either GUMLi or homogenised cow’s milk and will be followed for 12 months. The Growing Up Milk - "lite" is a toddler milk similar in composition to a commercially available toddler milk, but with reduced energy. Intervention: Growing Up Milk Lite Dose: 2 * 150ml of formula per day for a total of 12 months (from when the child turns 1 year of age until they turn 2 years of age). The Growing Up Milk is lower in energy than cow's milk and contains added micronutrients, dietary fibre and probiotics. Key differences in Growing Up Milk are: - 89.3kJ per 150mL serve - 1.1mcg Vitamin D per 150mL serve - 2.5mg Iron per 150mL serve - 174.3mg Calcium per 150mL serve Compliance will be measured sing information from monthly telephone interviews on the volume of milk consumed by the children in the previous 24 hours. Both study groups consume the same amounts of milk and have measures taken at identical time points.
Sponsors
The University of Auckland, Faculty of Medical and Health Science
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
11 Months to 12 Months
Healthy volunteers
Yes
Inclusion criteria
We will enrol children prior to the age of 12 months. They will remain in the study until they reach the age of 24 months. Children will be eligible to enrol if they are healthy and aged less than 12 months
Exclusion criteria
Children will be ineligible to enrol if they: Have a developmental disability (i.e. autism, intellectual disability) Have a significant health impairment that is likely to influence their nutritional status (e.g. Cerebral Palsy or a chronic illness known to cause malabsorption) Taking routine medication that is likely to interfere with iron absorption Have iron deficiency anaemia (Hb<100g/L). Have a medically diagnosed allergy to cow’s milk; or Parents whose written or spoken English comprehension is likely to make participation difficult for them or result in incomplete data collection for the study.
Outcome results
None listed