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ID
Source
Health condition
Absorption of fat and calcium, gut comfort, stool consistency.
Sponsors and support
Intervention
Outcome measures
Primary outcome
Fatty acids absorption
Secondary outcome
Calcium absorption and gut comfort.
Background summary
Breast milk represents optimum nutrition for full-term babies throughout infancy. An important component of breast milk is fat which covers approximately 50% of its caloric content. Almost 98% of fat in breast milk is in the form of triacylglycerols (TAGs). Palmitic acid (C16:0) is the major saturated fatty acid in the TAGs of breast milk, corresponding to 20-25% of its total fatty acid content. More than 60% of palmitic acid in breast milk is esterified to the second carbon (or â-position) of glycerol (sn-2) in the TAGs and as such it is called â-palmitate. Is has been proved by various clinical trials that this specific structure of human breast milk’s fat content can contribute in the absorption of fat and minerals, as well as overall gut comfort.
When breast-feeding is not adequate, feasible or desirable, infant formulae are the next alternative. Vegetable oils, that are traditionally used as matrices for the preparation of infant formulae, have a lower content of â-palmitate (i.e. 5-20% of their total palmitic acid content) compared to breast milk. On the other hand, cow’s milk content of â-palmitate, although lower than that of breast milk, is approximately 40%.
For these reasons, increasing the sn-2 palmitic acid content in milk formulae, by using cow’s milk fat, could potentially lead to a higher absorption of palmitic acid, total fatty acids and calcium, in comparison to milk formulae containing TAGs derived mainly from vegetable oils which have a high concentration of sn-1 and sn-3 palmitic acid.
Study objective
Infant formulae with higher levels of milk fat result in improved fatty acids absorption as compared to standard formula.
Study design
Fatty acids absorption:
stool sample analysis and food intake diary
timepoint: 2 and 4 weeks
Calcium absorption:
stool sample analysis and food intake diary
timepoint: 2 and 4 weeks
Gut comfort:
ROME III questionnaire and Amsterdam Infant Stool Scale
timepoint: 0, 2 and 4 weeks
Body weight & recumbent length
timepoint: 0, 2 and 4 weeks.
Intervention
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 infants will be randomly allocated to receive for 2 weeks (Period I) the standard formula, while the other half of the infants will be randomly allocated to receive a milk fat formula. After 2 weeks, the two groups will be crossed-over to receive the other formulae for the subsequent 2 weeks (Period II).
Bronland 20
Wageningen 6708 WH
The Netherlands
0031 6 13248135
inge.thijs-verhoeven@frieslandcampina.com
Bronland 20
Wageningen 6708 WH
The Netherlands
0031 6 13248135
inge.thijs-verhoeven@frieslandcampina.com
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
- 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
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
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In other registers
| Register | ID |
|---|---|
| NTR-new | NL6702 |
| NTR-old | NTR6872 |
| Other | FrieslandCampina Innovation : LLLP00 |