Absorption of fat and calcium, gut comfort, stool consistency.
Conditions
Interventions
Following recruitment and before treatment allocation all infants will be fed with a standard formula and this will be considered as a wash-out period. After the washout period, at week 0, half of the
Sponsors
FrieslandCampina N.V.
Eligibility
Inclusion criteria
Inclusion criteria: - Full-term, healthy infants (born at gestational age ≥37 weeks). - "Appropriate for gestational age" birthweight (i.e. 10th centile ≤ Birth weight ≤ 90th centile). - Age at enrolment: between 9th-14th week - Exclusively formula fed infants before and during the entire intervention period. - Parents willing and agreeing to initiate complementary feeding after the end of endpoint measurements, i.e. after the completion of the 5th month of age - Parents willing to collect stools and fill in all study questionnaires and diaries during the entire intervention period - Written informed consent
Exclusion criteria
Exclusion criteria: - Severe acquired or congenital diseases, mental or physical disorders, any symptoms of allergy (including cow¡¯s milk allergy). - No parents or siblings with documented CMA allergy, diagnosed by a doctor. - Use of probiotics, antibiotics or other medication that treats or causes GI symptoms and/or affect appetite at the time of screening or at any time throughout the study period (these infants will be considered as drop-outs). - Use of medication(s) known or suspected to affect fat digestion, absorption and/or metabolism; nutritional supplements; suppositories; medication that may suppress or neutralize gastric acid secretion and gut mobility at the time of screening or at any time throughout the study period (these infants will be considered as drop-outs). - Participation in another clinical trial. - Any type of mixed feeding (i.e. combination of formula with breastfeeding in any proportion) and/or complementary feeding during the intervention.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Fatty acids absorption | — |
Secondary
| Measure | Time frame |
|---|---|
| Calcium absorption and gut comfort. | — |
Contacts
Public ContactFrieslandCampina Innovation Centre
Outcome results
None listed