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Comparative fat absorption in healthy termed infants consuming infant formulae with different fat blends.


- candidate number28286
- NTR NumberNTR6872
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR1-dec-2017
- Secondary IDsLLLP00 FrieslandCampina Innovation
- Public TitleComparative fat absorption in healthy termed infants consuming infant formulae with different fat blends.
- Scientific TitleComparative fat absorption in healthy termed infants consuming infant formulae with different fat blends.
- ACRONYM
- hypothesisInfant formulae with higher levels of milk fat result in improved fatty acids absorption as compared to standard formula.
- Healt Condition(s) or Problem(s) studiedFat absorption, Calcium absorption, Stool consistency
- 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 cows 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.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupCrossover
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 5-dec-2017
- planned closingdate1-sep-2018
- Target number of participants44
- InterventionsFollowing 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).
- Primary outcomeFatty acids absorption
- Secondary outcomeCalcium absorption and gut comfort.
- TimepointsFatty 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.
- Trial web site-
- statusplanned
- CONTACT FOR PUBLIC QUERIES FrieslandCampina Innovation Centre
- CONTACT for SCIENTIFIC QUERIES FrieslandCampina Innovation Centre
- Sponsor/Initiator FrieslandCampina
- Funding
(Source(s) of Monetary or Material Support)
FrieslandCampina
- Publications
- Brief summaryBreast 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 -position) of glycerol (sn-2) in the TAGs and as such it is called -palmitate. Is has been proved by various clinical trials that this specific structure of human breast milks 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 -palmitate (i.e. 5-20% of their total palmitic acid content) compared to breast milk. On the other hand, cows milk content of -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 cows 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.
- Main changes (audit trail)
- RECORD1-dec-2017 - 15-dec-2017


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