NCT01627015

Brief 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 conventional follow-on formula containing higher glycaemic carbohydrates.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2012

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2012

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

June 21, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 25, 2012

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2014

Completed
Last Updated

March 9, 2015

Status Verified

March 1, 2015

Enrollment Period

1.8 years

First QC Date

June 21, 2012

Last Update Submit

March 6, 2015

Conditions

Infant Nutrition

Keywords

Fully formula fed

Outcome Measures

Primary Outcomes (1)

  • 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.

    After 4 week intervention period

Study Arms (2)

Modified infant follow-on formula

EXPERIMENTAL

Infants are fed a modified infant follow-on formula (modified carbohydrate composition) for 4 weeks, according to protocol

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

Other: Standard infant follow-on formula

Interventions

Modified infant follow-on formulaOTHER

The modified infant follow-on formula has a different carbohydrate pattern than the standard formula

Modified infant follow-on formula
Standard infant follow-on formulaOTHER

Infants are fed a commercial follow-on formula

Standard infant follow-on formula

Eligibility Criteria

Age4 Months - 6 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Germany, Hauner Childrens Hospital, Ludwig-Maximilians - University of Munich

Munich, 80337, Germany

Location

Related Publications (1)

  • 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.

    PMID: 26987056DERIVED

Study Officials

  • Berthold Koletzko, Prof.

    Germany, Hauner Childrens Hospital, Ludwig-Maximilians - University of Munich

    STUDY DIRECTOR

  • Berthold Koletzko, Prof.

    Germany, Hauner Childrens Hospital, Ludwig-Maximilians - University of Munich

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Berthold Koletzko

Study Record Dates

First Submitted

June 21, 2012

First Posted

June 25, 2012

Study Start

June 1, 2012

Primary Completion

April 1, 2014

Study Completion

April 1, 2014

Last Updated

March 9, 2015

Record last verified: 2015-03

Locations

DE(1)