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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01627015
Other study ID # 114-12
Secondary ID
Status Completed
Phase N/A
First received June 21, 2012
Last updated March 6, 2015
Start date June 2012
Est. completion date April 2014

Study information

Verified date March 2015
Source Ludwig-Maximilians - University of Munich
Contact n/a
Is FDA regulated No
Health authority Germany: Federal Institute for Drugs and Medical Devices
Study type Interventional

Clinical 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 conventional follow-on formula containing higher glycaemic carbohydrates.


Recruitment information / eligibility

Status Completed
Enrollment 50
Est. completion date April 2014
Est. primary completion date April 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 4 Months to 6 Months
Eligibility Inclusion Criteria:

- 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

Exclusion Criteria:

- 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)


Related Conditions & MeSH terms


Intervention

Other:
Modified infant follow-on formula
The modified infant follow-on formula has a different carbohydrate pattern than the standard formula
Standard infant follow-on formula
Infants are fed a commercial follow-on formula

Locations

Country Name City State
Germany Germany, Hauner Childrens Hospital, Ludwig-Maximilians - University of Munich Munich

Sponsors (2)

Lead Sponsor Collaborator
Ludwig-Maximilians - University of Munich Beneo GmbH

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 No
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