|- candidate number||19598|
|- NTR Number||NTR4829|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||3-okt-2014|
|- Secondary IDs||NL47744.029.14 METC VU medisch centrum|
|- Public Title||ProtEUs|
|- Scientific Title||ProtEUs: Effects of an infant formula with an optimized amino acid composition on growth and body
composition in infants|
|- hypothesis||We hypothesize that an infant formula with an optimized amino acid composition and a lower protein content during the first 26 weeks of age is safe and results in comparable growth to standard formula fed infants at 17 weeks of age.|
Furthermore we hypothesize that infant formula with an optimized amino acid profile and a lower protein level exhibits beneficial effects on weight gain, body composition and metabolic diseases in later life.
|- Healt Condition(s) or Problem(s) studied||Protein, Intake, Body composition, Early feeding |
|- Inclusion criteria||- Born at term (born >37 weeks of gestation)|
- Birth weight between p3 and p97 (WHO growth curves birth to 6 months of age)
- Age ≤ 45 days after birth
- Formula-fed (administration of one feed/gift human milk per day is allowed) OR human milk-fed (administration of one feed/gift infant formula per day is allowed.
- Written informed consent of both parents or legal guardians
|- Exclusion criteria||- Multiple birth |
- Infants known to have current or previous illnesses/conditions or intervention which could interfere with the study (growth), as per investigator’s clinical judgement
- Infants with known congenital diseases or malformations which could interfere with the study (e.g. gastrointestinal malformations, congenital immunodeficiency), as per investigator’s clinical judgement
- Infants who need to be fed with a special diet other than a standard cow‘s milk-based infant formula
- Infants with any history of or current participation in any other study involving investigational or marketed products.
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-okt-2014|
|- planned closingdate||1-feb-2017|
|- Target number of participants||291|
|- Interventions||Formula-fed infants will be randomized into group A (test product) or group B (control product). Infants in group A will receive an infant formula with an optimized amino acid composition and infants in group B will receive an infant formula based on the standard amino acid composition. The study intervention ends at 26 weeks of age. |
|- Primary outcome||The primary objective of this study is to investigate equivalence of weight gain from randomisation until 17 weeks of age in infants receiving the formula with an optimized amino acid composition and a lower total protein content compared to infants receiving the control product: a formula with a standard amino acid composition and protein content.|
|- Secondary outcome||Body composition: |
- Body fat percentage
- Fat-free mass (FFM)
- Fat mass (FM)
- Fat-free mass index (FFMI)
- Fat mass index (FMI)
- Skinfold thickness
Plasma concentrations of:
- Total IGF-1
- IGFBP1, IGFBP2, IGFBP3
- Amino acid profile
- Polar lipids
- Head circumference
- Waist circumference
- Mid-arm circumference
|- Timepoints||The infants will visit the hospital 3 times during the study: at baseline and at 4 and 6 months of age. During the whole intervention period, nutritional intake will be measured by a food questionnaire.|
|- Trial web site||-|
|- status||inclusion stopped: follow-up|
|- CONTACT FOR PUBLIC QUERIES||Prof. Dr. J.B. Goudoever, van|
|- CONTACT for SCIENTIFIC QUERIES||Prof. Dr. J.B. Goudoever, van|
|- Sponsor/Initiator ||VU University Medical Center|
(Source(s) of Monetary or Material Support)
|EU FP 7 |
|- Brief summary||The prevalence of childhood obesity is increasing rapidly, its prevention is becoming a public health priority. Several
observational studies have shown an association between early nutrition and the risk of developing obesity later in life.|
Formula-fed infants are more likely to become overweight compared with breast-fed infants. An important reason for this
appears to be the higher protein content of formula. An infant formula with improved protein quality and a lower protein
quantity may be of benefit to infants.
Objective of the study:
To assess the effect of an infant formula with an optimized amino acid composition and a lower total protein content
during the first four months of life on infant growth.
Multicenter, double blind, randomized controlled trial.
Healthy term infants.
Intervention (if applicable):
The intervention group (group A) will receive an infant formula with an optimized amino acid composition and reduced
protein content (test product) and the control group (group B) will receive infant formula with a standard amino acid
composition until the 26th week of age (control product). The intervention will start before the 45th day of life. Data on theprimary and secondary endpoints will be collected until 26 weeks of age.
A reference group with breast-fed infants (group C) will undergo the same measurements at the same time points.
Primary study parameters/outcome of the study:
Infant weight gain from inclusion to the age of 17 weeks.
Secundary study parameters/outcome of the study (if applicable):
- Body composition
- Blood concentrations of total IGF-1, glucose, insulin, IGFBP1, IGFBP2, IGFBP3, leptin, amino acid profile, urea,
- Anthropometric measurements: length, waist circumference, head circumference, mid-arm circumference.
- Composition of fecal microbiota.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness (if
The infants will visit the hospital 3 times during the study: at baseline and at 4 and 6 months of age. Each visit will take
about an hour. A blood sample will be taken at the age of 4 months. The amount of blood that will be taken is minimal (3
ml). During the intervention period, nutritional intake will be measured by a food questionnaire. For the determination of
body composition, the infants will visit the hospital 3 times during the intervention period.
There are no reasons to expect any risks from consumption of a formula partially based on free amino acids. There are
various reasons to hypothesize that infant formula with an optimized amino acid profile and a lower protein level exhibits
beneficial effects on growth, body composition and metabolic diseases in later life. Therefore it is possible that infants
fed with this formula may benefit from participation in the study by lower risk of overweight later in life.
Countries of recruitment: The Netherlands and Germany
|- Main changes (audit trail)|
|- RECORD||3-okt-2014 - 7-feb-2017|