Infant NutritionBEMIMNCT01094080
Formula With Modified Content of Protein and Improved Fatty Acids and Their Impact on Infant Growth and Health
A study testing standard infant formula, modified infant formula and breast milk in people with Infant Nutrition, run by Ludwig-Maximilians - University of Munich at 2 sites in 2 countries.
Trial summary
In this study, the suitability of an infant formula with a modified content of protein and fatty acid pattern (LC-PUFA) for healthy term infants will be investigated. Primary hypothesis to be tested is: an infant formula with a modified protein content is non inferior compared to a standard infant formula in respect… Read more about this study
- Who is it for?
- Ages 3 to 28 daysHealthy volunteers can take part
- Conditions the study is for
- Infant Nutrition
- What is being tested?
- standard infant formula, modified infant formula and breast milk
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 505 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Feb 2010to May 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 28 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- healthy term newborn
- gestational age between 37 and 41 weeks
- birth weight between the 3th and 97th weight-for-age percentile according to the EURO-Growth charts
- fully bottle-fed (at the latest with 28 days of age) or fully breast fed
- written parental informed consent
- Serbian nationality
Who cannot join
- malformations, congenital heart defect, congenital vascular disease, severe diseases of gastrointestinal tract, kidney, liver, central nervous system and/or metabolic disease
- intensive care during first 14 days of life
- participation in any other clinical study intervention
- twins, multiple birth
- neonatal infection
- medication and parenteral nutrition
Show all 9Show fewer
- metabolic disorders
- birth-related complications
- severe disturbances of neonatal adaption
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Germany1 site
Hauner Childrens Hospital, LudwigMaximilans Universität
München, D-80337
Serbia1 site
Institute for Gynecology and Obstretition of Clinical Center
Belgrade, 11000
About this study
In this study, the suitability of an infant formula with a modified content of protein and fatty acid pattern (LC-PUFA) for healthy term infants will be investigated.
Primary hypothesis to be tested is: an infant formula with a modified protein content is non inferior compared to a standard infant formula in respect to the growth of healthy term infants.
- Conditions
- Infant Nutrition
- Being tested
- standard infant formula, modified infant formula, breast milk
- Keywords
- fully formula fed, fully breast fed
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
standard infant formulaOther
infants are fed a commercial formula
modified infant formulaOther
the modified infant formula has a different protein content than the standard formula and long chain polyunsaturated fatty acids are added
breast milkOther
infants are breast fed
| Study group | Role | What they receive |
|---|---|---|
| standard infant formula | Active comparator | infants are fed a commercial formula during the first 4 month of life, according to protocol Receives: Other: standard infant formula |
| modified infant formula | Experimental | infants are fed a modified infant formula (modified protein content and fatty acid pattern) during the first 4 month of life, according to protocol Receives: Other: modified infant formula |
| breast milk | Other | infants are breast fed Receives: Other: breast milk |
What is being measured
The primary outcome is the main question the study is designed to answer.
change of weight from day 30 to day 120
Measured: postnatal age 30 to 120 days
Secondary outcomes (4)
anthropometry
including body length, head circumference and derived parameter e.g. weight (from primary outcome) for length
Measured: postnatal day 30, day 60, day 90, day 120 days
blood markers
Measured: postnatal day 30, day 60, day 90, day 120 days (120 only)
Follow-up
At 4 Years of Age, an Interview Regarding Severe Events and Growth Since Study End Will be Performed and Anthropometric Data (Weight, Length, Head Circumference and Body Composition Measured Via Skinfolds and BIA) Will be Collected.
Measured: 4 Years of age
Follow-up at age 7 years with an interview regarding severe events and growth
At 7 years of age we will perform anthropometric measurements (weight, height, head circumference and skinfolds) and bioimpedance measurement (from skinfolds and bioimpedance body composition will be estimated) additionally in an interview information on severe events (i.e. diseases) will be collected
Measured: 7 years of age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2010 (estimated)
- Study startFeb 2010
- Primary completionSep 2011
- Study completionMay 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Infant NutritionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 505 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ludwig-Maximilians - University of Munich
- Sponsor type
- University, hospital or other
- Collaborators
- HiPP GmbH & Co. Vertrieb KG
- Responsible party
- Principal investigator, Prof. Berthold Koletzko, Ludwig-Maximilians - University of Munich
- Investigators
- Berthold Koletzko, Prof., Study director, Hauner Children Hospital, Ludwig Maximilians UniversitätTatjana Nicolić Nicolić, Dr., Principal investigator, Institute for Gynecology and Obstretition of Clinical Center Belgrade
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01094080
- Sponsor's protocol ID
- 502042
- Acronym
- BEMIM
- Status last verified
- Sep 2020
- First submitted
- 1 Feb 2010
- Last updated
- 2 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
Fleddermann M, Demmelmair H, Grote V, Nikolic T, Trisic B, Koletzko B. Infant formula composition affects energetic efficiency for growth: the BeMIM study, a randomized controlled trial. Clin Nutr. 2014 Aug;33(4):588-95. doi: 10.1016/j.clnu.2013.12.007. Epub 2013 Dec 30.
PubMed 24411489Fleddermann M, Demmelmair H, Grote V, Bidlingmaier M, Grimminger P, Bielohuby M, Koletzko B. Role of selected amino acids on plasma IGF-I concentration in infants. Eur J Nutr. 2017 Mar;56(2):613-620. doi: 10.1007/s00394-015-1105-9. Epub 2015 Nov 30.
PubMed 26621633
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Formula With Modified Content of Protein and Improved Fatty Acids and Their Impact on Infant Growth and Health
- ClinicalTrials.gov ID
- NCT01094080
- Acronym / sponsor ID
- BEMIM / 502042
- Conditions
- Infant Nutrition
- Keywords
- fully formula fed, fully breast fed
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 505 participants (actual)
- Lead sponsor
- Ludwig-Maximilians - University of MunichUniversity, hospital or other
- Collaborators
- HiPP GmbH & Co. Vertrieb KG
- Study start
- Feb 2010
- Primary completion
- Sep 2011 (actual)
- Study completion
- May 2018 (actual)
- First posted
- 26 Mar 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In this study, the suitability of an infant formula with a modified content of protein and fatty acid pattern (LC-PUFA) for healthy term infants will be investigated.
Primary hypothesis to be tested is: an infant formula with a modified protein content is non inferior compared to a standard infant formula in respect to the growth of healthy term infants.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| standard infant formula | Active comparator | Other: standard infant formulainfants are fed a commercial formula during the first 4 month of life, according to protocol |
| modified infant formula | Experimental | Other: modified infant formulainfants are fed a modified infant formula (modified protein content and fatty acid pattern) during the first 4 month of life, according to protocol |
| breast milk | Other | Other: breast milkinfants are breast fed |
Who may qualify
- Ages
- 3 to 28 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- healthy term newborn
- gestational age between 37 and 41 weeks
- birth weight between the 3th and 97th weight-for-age percentile according to the EURO-Growth charts
- fully bottle-fed (at the latest with 28 days of age) or fully breast fed
- written parental informed consent
Key exclusion criteria (9 listed)
- malformations, congenital heart defect, congenital vascular disease, severe diseases of gastrointestinal tract, kidney, liver, central nervous system and/or metabolic disease
- intensive care during first 14 days of life
- participation in any other clinical study intervention
- twins, multiple birth
- neonatal infection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| standard infant formulainfants are fed a commercial formula | Other | standard infant formula |
| modified infant formulathe modified infant formula has a different protein content than the standard formula and long chain polyunsaturated fatty acids are added | Other | modified infant formula |
| breast milkinfants are breast fed | Other | breast milk |
Primary outcome
change of weight from day 30 to day 120
Time frame: postnatal age 30 to 120 days
4 secondary outcomes
anthropometry
Time frame: postnatal day 30, day 60, day 90, day 120 days
blood markers
Time frame: postnatal day 30, day 60, day 90, day 120 days (120 only)
Follow-up
Time frame: 4 Years of age
Follow-up at age 7 years with an interview regarding severe events and growth
Time frame: 7 years of age
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2020.
- Results publication: PubMed 24411489Fleddermann M, Demmelmair H, Grote V, Nikolic T, Trisic B, Koletzko B. Infant formula composition affects energetic efficiency for growth: the BeMIM study, a randomized controlled trial. Clin Nutr. 2014 Aug;33(4):588-95. doi: 10.1016/j.clnu.2013.12.007. Epub 2013 Dec 30.
- Results publication: PubMed 26621633Fleddermann M, Demmelmair H, Grote V, Bidlingmaier M, Grimminger P, Bielohuby M, Koletzko B. Role of selected amino acids on plasma IGF-I concentration in infants. Eur J Nutr. 2017 Mar;56(2):613-620. doi: 10.1007/s00394-015-1105-9. Epub 2015 Nov 30.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Berthold Koletzko, Prof. study director
Hauner Children Hospital, Ludwig Maximilians Universität
Tatjana Nicolić Nicolić, Dr. principal investigator
Institute for Gynecology and Obstretition of Clinical Center Belgrade
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing standard infant formula, modified infant formula and breast milk in people with Infant Nutrition, run by Ludwig-Maximilians - University of Munich at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany, Serbia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change of weight from day 30 to day 120 (time frame: postnatal age 30 to 120 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01094080, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2020.