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Safety, Acceptance and Metabolic Effects in Infants Receiving a Novel Low Glycaemic Index follow-on Formula

NCT01627015 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2015-03-09

No results posted yet for this study

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.

Conditions

  • Infant Nutrition

Interventions

OTHER

Modified infant follow-on formula

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

OTHER

Standard infant follow-on formula

Infants are fed a commercial follow-on formula

Sponsors & Collaborators

  • Beneo GmbH

    collaborator INDUSTRY

  • Ludwig-Maximilians - University of Munich

    lead OTHER

Principal Investigators

  • Berthold Koletzko, Prof. · Germany, Hauner Childrens Hospital, Ludwig-Maximilians - University of Munich

  • Berthold Koletzko, Prof. · Germany, Hauner Childrens Hospital, Ludwig-Maximilians - University of Munich

Study Design

Allocation
RANDOMIZED
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
4 Months
Max Age
6 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-06-30
Primary Completion
2014-04-30
Completion
2014-04-30

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01627015 on ClinicalTrials.gov