Infant NutritionNCT01627015
Safety, Acceptance and Metabolic Effects in Infants Receiving a Novel Low Glycaemic Index follow-on Formula
A study testing Modified infant follow-on formula and Standard infant follow-on formula in people with Infant Nutrition, run by Ludwig-Maximilians - University of Munich at 1 site in Germany.
Trial summary
In this study, the safety, acceptance and metabolic effects in infants receiving a novel low glycaemic index follow-on formula will be investigated. After 4 week intervention period, metabolic response after feeding is significantly different between a follow-on formula containing low glycaemic carbohydrate and a… Read more about this study
- Who is it for?
- Ages 4 to 6 monthsHealthy volunteers can take part
- Conditions the study is for
- Infant Nutrition
- What is being tested?
- Modified infant follow-on formula and Standard infant follow-on formula
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteGermany
- Study dates
- Jun 2012to Apr 2014
- 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 4 to 6 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- generally healthy infants born
- weight between 10th and 90th percentile for age, according to the EURO Growth guidelines
- age between 5 - 7th month of life at study entry
- fully formula fed for at least 4 weeks before intervention start
- parents/caregivers understand the German language and are able to fill out questionnaires
- parents/caregivers agree to study participation and sign the informed consent form
Who cannot join
- acute or chronic illness of infant or mother
- drug and/or alcohol abuses of mother
- chronic medication
- participation of the infant in another intervention study
- gestational diabetes of the mother
Trial locations and contacts
1 site in 1 country.
Germany1 site
Germany, Hauner Childrens Hospital, Ludwig-Maximilians - University of Munich
Munich, 80337
About this study
In this study, the safety, acceptance and metabolic effects in infants receiving a novel low glycaemic index follow-on formula will be investigated.
After 4 week intervention period, metabolic response after feeding is significantly different between a follow-on formula containing low glycaemic carbohydrate and a conventional follow-on formula containing higher glycaemic carbohydrates.
- Conditions
- Infant Nutrition
- Being tested
- Modified infant follow-on formula, Standard infant follow-on formula
- Keywords
- Fully formula fed
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Modified infant follow-on formulaOther
The modified infant follow-on formula has a different carbohydrate pattern than the standard formula
Standard infant follow-on formulaOther
Infants are fed a commercial follow-on formula
| Study group | Role | What they receive |
|---|---|---|
| Modified infant follow-on formula | Experimental | Infants are fed a modified infant follow-on formula (modified carbohydrate composition) for 4 weeks, according to protocol Receives: Other: Modified infant follow-on formula |
| Standard infant follow-on formula | Active comparator | Infants are fed a commercial follow-on formula for 4 weeks, according to protocol Receives: Other: Standard infant follow-on formula |
What is being measured
The primary outcome is the main question the study is designed to answer.
metabolic response
After 4 week intervention period, metabolic response after feeding is significantly different between a follow-on formula containing low glycaemic carbohydrate and a conventional follow-on formula containing higher glycaemic carbohydrates.
Measured: After 4 week intervention period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2012 (estimated)
- Study startJun 2012
- Primary completionApr 2014
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ludwig-Maximilians - University of Munich
- Sponsor type
- University, hospital or other
- Collaborators
- Beneo GmbH
- Responsible party
- Principal investigator, Koletzko - Office, Ludwig-Maximilians - University of Munich
- Investigators
- Berthold Koletzko, Prof., Study director, Germany, Hauner Childrens Hospital, Ludwig-Maximilians - University of MunichBerthold Koletzko, Prof., Principal investigator, Germany, Hauner Childrens Hospital, Ludwig-Maximilians - University of Munich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01627015
- Sponsor's protocol ID
- 114-12
- Status last verified
- Mar 2015
- First submitted
- 21 Jun 2012
- Last updated
- 9 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Fleddermann M, Rauh-Pfeiffer A, Demmelmair H, Holdt L, Teupser D, Koletzko B. Effects of a Follow-On Formula Containing Isomaltulose (Palatinose) on Metabolic Response, Acceptance, Tolerance and Safety in Infants: A Randomized-Controlled Trial. PLoS One. 2016 Mar 17;11(3):e0151614. doi: 10.1371/journal.pone.0151614. eCollection 2016.
PubMed 26987056
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety, Acceptance and Metabolic Effects in Infants Receiving a Novel Low Glycaemic Index follow-on Formula
- ClinicalTrials.gov ID
- NCT01627015
- Acronym / sponsor ID
- 114-12
- Conditions
- Infant Nutrition
- Keywords
- Fully formula fed
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Ludwig-Maximilians - University of MunichUniversity, hospital or other
- Collaborators
- Beneo GmbH
- Study start
- Jun 2012
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 25 Jun 2012 (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 safety, acceptance and metabolic effects in infants receiving a novel low glycaemic index follow-on formula will be investigated.
After 4 week intervention period, metabolic response after feeding is significantly different between a follow-on formula containing low glycaemic carbohydrate and a conventional follow-on formula containing higher glycaemic carbohydrates.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Modified infant follow-on formula | Experimental | Other: Modified infant follow-on formulaInfants are fed a modified infant follow-on formula (modified carbohydrate composition) for 4 weeks, according to protocol |
| Standard infant follow-on formula | Active comparator | Other: Standard infant follow-on formulaInfants are fed a commercial follow-on formula for 4 weeks, according to protocol |
Who may qualify
- Ages
- 4 to 6 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- generally healthy infants born
- weight between 10th and 90th percentile for age, according to the EURO Growth guidelines
- age between 5 - 7th month of life at study entry
- fully formula fed for at least 4 weeks before intervention start
- parents/caregivers understand the German language and are able to fill out questionnaires
Key exclusion criteria (5 listed)
- acute or chronic illness of infant or mother
- drug and/or alcohol abuses of mother
- chronic medication
- participation of the infant in another intervention study
- gestational diabetes of the mother
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 |
|---|---|---|
| Modified infant follow-on formulaThe modified infant follow-on formula has a different carbohydrate pattern than the standard formula | Other | Modified infant follow-on formula |
| Standard infant follow-on formulaInfants are fed a commercial follow-on formula | Other | Standard infant follow-on formula |
Primary outcome
metabolic response
Time frame: After 4 week intervention period
After 4 week intervention period, metabolic response after feeding is significantly different between a follow-on formula containing low glycaemic carbohydrate and a conventional follow-on formula containing higher glycaemic carbohydrates.
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 9 Mar 2015.
- Derived from this study: PubMed 26987056Fleddermann M, Rauh-Pfeiffer A, Demmelmair H, Holdt L, Teupser D, Koletzko B. Effects of a Follow-On Formula Containing Isomaltulose (Palatinose) on Metabolic Response, Acceptance, Tolerance and Safety in Infants: A Randomized-Controlled Trial. PLoS One. 2016 Mar 17;11(3):e0151614. doi: 10.1371/journal.pone.0151614. eCollection 2016.
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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
Germany, Hauner Childrens Hospital, Ludwig-Maximilians - University of Munich
Berthold Koletzko, Prof. principal investigator
Germany, Hauner Childrens Hospital, Ludwig-Maximilians - University of Munich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Modified infant follow-on formula and Standard infant follow-on formula in people with Infant Nutrition, run by Ludwig-Maximilians - University of Munich at 1 site in Germany.
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 5 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 9 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. 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?
metabolic response (time frame: After 4 week intervention period). 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 NCT01627015, which also lists 1 linked publication.
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 9 Mar 2015.