Safety, Acceptance and Metabolic Effects in Infants Receiving a Novel Low Glycaemic Index follow-on Formula
Not Applicable
Completed
- Conditions
- Infant Nutrition
- Registration Number
- NCT01627015
- Lead Sponsor
- Ludwig-Maximilians - University of Munich
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 50
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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method metabolic response 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Germany, Hauner Childrens Hospital, Ludwig-Maximilians - University of Munich
🇩🇪Munich, Germany
Germany, Hauner Childrens Hospital, Ludwig-Maximilians - University of Munich🇩🇪Munich, Germany