None listed
Conditions
Interventions
Duration of intervention: 20 weeks
Intervention group: low energy Growing up Milk
Control group: Cows Milk.
Both products will be taken in amounts of 300-500 ml/day. Both products will be available as a powder.
Sponsors
Danone Research – Centre for Specialised Nutrition
Eligibility
Inclusion criteria
Inclusion criteria: 1. Apparently healthy male and female subjects between 12 and 36 months of age; 2. Stable health status (i.e. being unknown with chronic or recent acute diseases) and expected to remain stable; 3. Familiar with and currently drinking milk products; expected study product intake of 300-500 ml per day; 4. Written informed consent from parents.
Exclusion criteria
Exclusion criteria: 1. Known infection during the last week or infection needing medical assistance or treatment during the last 2 weeks; 2. Any case of anaemia treated with pharmaceutical product in the last three months; 3. Any relevant congenital abnormality, chromosomal disorder or severe disease (such as tracheoesophageal fistula, tracheomalacia, major congenital heart disease, Down’s syndrome, HIV, cancer); 4. Disorders requiring a special diet (such as food intolerance or food allergy or complaints such as reflux, constipation and cramps for which special toddler formula is required); 5. Current use of anti-regurgitation, anti-reflux or laxative medication; 6. Known hemoglobinopathies or thalassaemia; 7. Blood transfusion received within the last 6 months; 8. Investigator’s uncertainty about the willingness or ability of the parents to comply with the protocol requirements; 9. Participation in any other study involving investigational or marketed products concomitantly or within 2 weeks prior to entering the study; 10. Expected or foreseen inability of the subject and/or their families to adhere to protocol instructions, including daily completion of the diary by the parents; 11. Known allergy or intolerance to components of the investigational and/or control study product, eg. milk powder, lactose or fish protein; 12. Vaccination with a live or live-attenuated vaccine received during the last two weeks.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome parameter in this study is the change in serum SF concentrations after 20 weeks of study product consumption. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Prevalence of ID and IDA: A. ID is defined as SF <12 µg/l; B. IDA is defined as blood haemoglobin (Hb) <110 g/l, combined with SF <12 µg/l. 2. Biochemical assessments of vitamin D status: change from baseline in serum 25(OH)D concentrations; 3. Prevalence of vitamin D deficiency, defined as serum 25(OH)D < 50 nmol/l. | — |
Contacts
Public ContactTarik Hessabi
P.O. Box 7005
Outcome results
None listed