An exploratory study to evaluate the effect of a new study product on early programming in healthy infants
- Conditions
- healthy subjectsdigestion and absorption
- Registration Number
- NL-OMON34471
- Lead Sponsor
- Danone Vitapole
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 28
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)
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Absorption and digestion of feed components.</p><br>
- Secondary Outcome Measures
Name Time Method <p>NA</p><br>