No registrations found.
ID
Source
Brief title
Health condition
Healthy infants
Sponsors and support
Intervention
Outcome measures
Primary outcome
Key outcome: Body Mass Index (BMI) at 3, 4, and 5 years of age
Secondary outcome
- Prevalence of overweight and obesity at 3, 4, and 5 years of age
- Sum of skin fold thicknesses at 3, 4, and 5 years of age
- Percentage total body fat (derived from skinfolds)
- Head- and waist- circumference at 3, 4, and 5 years of age
Background summary
The present study is a follow up study of the original Mercurius study (NTR3683) at the age of 3-5 years. The main objective of this study is to gain insight into the possible long-term effects, up to 5 years of age, on growth and body composition development in subjects who have received the test product compared to subjects who have received the control product in the first 4 months of age and in comparison to the breastfed reference group. Study visits will take place at 3, 4 and 5 years of age. A phone call will take place at 3.5 and 4.5 years of age.
Study objective
The infant formula containing a new fat blend, consumed in the first 4 months of life, will have a positive effect on the growth trajectory in toddlerhood up to 5 years of age.
Study design
Visit at 3, 4 and 5 years of age. Phone call at 3.5 and 4.5 years of age
Intervention
N/A
Anneke Ravensbergen
PO box 80141
Utrecht 3508 TC
The Netherlands
+31(30) 209 5000
Anneke.ravensbergen@danone.com
Anneke Ravensbergen
PO box 80141
Utrecht 3508 TC
The Netherlands
+31(30) 209 5000
Anneke.ravensbergen@danone.com
Inclusion criteria
- Subjects that participated in the original Mercurius study (NTR3683) up to visit 5 (approx. 4 months of age) are eligible for this follow up study.
- Written Informed Consent
Exclusion criteria
- Investigator's uncertainty about the willingness or ability of the child and parents to comply with the protocol requirements.
- Subjects that were recruited by investigators who decided not to participate in the 5 year follow up study.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL5421 |
| NTR-old | NTR5538 |
| Other | : EPI1.C.C Nutricia Research |