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

Ludwig-Maximilians - University of Munich50 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Masking

QUADRUPLE

Enrollment

Conditions

Infant Nutrition

Interventions

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

Eligibility

Sex: ALLMin age: 4 MonthsMax age: 6 MonthsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

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

Munich, Germany

Outcomes

Primary Outcomes

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.

Time frame: After 4 week intervention period

Data from ClinicalTrials.gov

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