To compare the new IMF with the control IMF.
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
healthy subjects
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Absorption and digestion of feed components.
Secondary outcome
NA
Background summary
A study to compare a new infant milk formula (IMF) with a control IMF in
healthy infants.
Study objective
To compare the new IMF with the control IMF.
Study design
7 week intervention with the new IMF versus a control IMF.
Intervention
7 week feed with the new IMF or the control IMF
Study burden and risks
2x2 Blood samples are collected via heelprick.
Bosrandweg 20
6704 PH Wageningen
NL
Bosrandweg 20
6704 PH Wageningen
NL
Listed location countries
Age
Inclusion criteria
Healthy and full-term infants (gestational age * 37 and * 42 weeks)
Birth weight within the normal range for gestational age and sex (10th to 90th percentiles according to applicable growth charts)
Age * 7 weeks at screening
Body weight appropriate for the individual age and sex at screening (10th to 90th percentiles according to applicable growth charts)
Infants who are fully formula fed or have started the transition from breast- to formula-feeding (indicated by the feeding of at least one bottle of infant formula in the past) and are planning to stop breastfeeding voluntarily by infant*s age of 7 weeks
Written informed consent of both parent(s)/legal guardian(s)
Exclusion criteria
Infants not on full formula feeding at the age of 7 weeks (to be answered latest at the age of 8 weeks (visit 2))
Infants with known congenital diseases or malfunctions e.g. gastrointestinal malformations, haemophilia
Current or previous illnesses which could interfere with the study (e.g. prolonged severe diarrhoea, regurgitation)
*Infants with abnormal growth (too slow (< -1SD) or too fast (> +1SD) weight gain) within the 10th to 90th percentiles of applicable weight-for-age charts for either boys or girls
Infants at high risk to develop an atopic disease (at least one parent or sibling with manifest atopic symptoms of hay fever, asthma or atopic dermatitis)
Infants needing a special diet other than standard cow*s milk-based infant milk formula
*Infants whose mothers are known to suffer from hepatitis B, human immunodeficiency virus (HIV), high blood-pressure, hyperlipidaemia or diabetes
Infants whose mother was overweight (BMI * 27) prior to pregnancy
Infants with any historical or current participation in any other study involving investigational or marketed products
Investigator's uncertainty about the willingness or ability of the parents to comply with the protocol requirements and instructions
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 |
|---|---|
| CCMO | NL32379.000.10 |