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

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.

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Key information

Conditions

Infant Nutrition

Age range

4 month–6 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Munich, 80337, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Modified infant follow-on formula

Other

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

Standard infant follow-on formula

Other

Infants are fed a commercial follow-on formula

Primary outcomes

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.

Sponsors and collaborators

Lead sponsor

Ludwig-Maximilians - University of Munich

Other

Collaborators

Beneo GmbH

Registry information

Important dates

Study start: 2012
Primary completion: 2014
Study completion: 2014
First posted: Jun 25, 2012
Registry last updated: Mar 9, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed