An exploratory study to evaluate the effect of a new study product on early programming in healthy infants.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON21169

Enrollment

Registered

2011-01-27

Start date

2011-02-08

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy term infants

Interventions

7 weeks randomised on either investigational or control product. The investigational product is a new formula containing CLM. The control product is a standard formula. The investigational product is

Eligibility

Inclusion criteria

Inclusion criteria: 1. Healthy and full-term infants (gestational age between 37 and 42 weeks); 2. Birth weight within the normal range for gestational age and sex (10th to 90 percentiles according to applicable growth charts); 3. Age 7 weeks at screening; 4. Body weight appropriate for the individual age and sex at screening (10th to 90 percentiles according to applicable growth charts); 5. 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; 6. Written informed consent of both parent(s)/legal guardian(s).

Exclusion criteria

Exclusion criteria: 1. Infants not on full formula feeding at the age of 7 weeks (to be answered latest at the age of 8 weeks (visit 2)); 2. Infants with known congenital diseases or malfunctions e.g. gastrointestinal malformations, haemophilia; 3. Current or previous illnesses which could interfere with the study (e.g. prolonged severe diarrhoea, regurgitation); 4. Infants with abnormal growth (too slow ( +1SD) weight gain) within the 10th to 90th percentiles of applicable weight-for-age charts for either boys or girls; 5. 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); 6. Infants needing a special diet other than standard cow's milk-based infant.

Design outcomes

Primary

Measure	Time frame
Digestion and absorption, measured as blood lipid parameters.	—

Contacts

Public ContactJan van der Mooren

Director Clinical Research Platform PO Box 80141

Eva.DE-HOIJER@external.nutricia.com+31-30-2095000

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)