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. Amendment follow-up study: To assess the long term effect of the intake of an…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
Groei, overgewicht en obesitas
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Infant weight gain from inclusion to the age of 17 weeks.
Amendment follow-up study: BMI at the age of 6 years.
Secondary outcome
- Body composition
- Blood concentrations of total IGF-1, glucose, insulin, IGFBP1, IGFBP2,
IGFBP3, leptin, amino acid profile, urea, metabolomics.
- Anthropometric measurements: length, waist circumference, head circumference,
mid-arm circumference.
- Composition of fecal microbiota.
Amendment follow-up study:
- Body composition
- Blood concentrations of total IGF-1, glucose, insulin, IGFBP1, IGFBP2,
IGFBP3, leptin, amino acid profile, urea, metabolomics.
- Anthropometric measurements: weight, length, waist circumference, head
circumference, mid-arm circumference.
- Composition of fecal microbiota.
- Blood pressure
Background 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.
Amendment follow-up study: The quantity and quality of protein intake during
the first months of life seems to have a programming effects on the risk of
obesity and associated diseases. The intake of an infant formula with an
optimized amino acid composition and a lower total protein content leads to a
lower BMI compared to infants fed with standard formula. We hypothesize that
the intake of an infant formula with a lower protein content leads to a more
beneficial body composition (e.g. lower body fat percentage) and metabolic
profile compared to the intake of standard formula.
Study objective
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.
Amendment follow-up study: To assess the long term effect of the intake of an
infant formula with an optimized amino acid composition and a lower total
protein content during the first months of life on growth.
Study design
Multicenter, double blind, randomized controlled trial.
Intervention
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 the primary 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.
Amendment follow-up study: no additional intervention
Study burden and risks
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.
Amendment follow-up study: The infants will visit the hospital 3 times during
the follow-up study: at the age of 1, 2 and 6 years of age. Each visit will
take about an hour. A blood sample will be taken at every visit. The amount of
blood that will be taken is minimal (3 ml). During the follow-up period,
nutritional intake will be measured by a food diary. For the determination of
body composition, the infants will visit the hospital 3 times during the
follow-up period. A feaces sample will be taken at the age of 1,2 and 6 years
of age. Blood pressure will be measured at the age of 6 years.
There are no reasons to expect any risks from participating in the follow-up
study. There will be no intervention.
De Boelelaan 1117
Amsterdam 1081 HV
NL
De Boelelaan 1117
Amsterdam 1081 HV
NL
Listed location countries
Age
Inclusion criteria
- Healthy term infants
- Age <= 45 days after birth
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.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL47744.029.14 |