Safety, Acceptance and Metabolic Effects in Infants Receiving a Novel Low Glycaemic Index follow-on Formula
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Infant Nutrition
- Sponsor
- Ludwig-Maximilians - University of Munich
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- metabolic response
- Status
- Completed
- Last Updated
- 11 years ago
Overview
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.
Investigators
Koletzko - Office
Prof. Berthold Koletzko
Ludwig-Maximilians - University of Munich
Eligibility Criteria
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
Outcomes
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.