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

Study Overview
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Brief Summary
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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.

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

Conditions
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Infant Nutrition

Intervention / Treatment
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* Other: Modified infant follow-on formula
* Other: Standard infant follow-on formula


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 4 Months
Maximum Age: 6 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Modified infant follow-on formula<br>Infants are fed a modified infant follow-on formula (modified carbohydrate composition) for 4 weeks, according to protocol | Other: Modified infant follow-on formula<br>* The modified infant follow-on formula has a different carbohydrate pattern than the standard formula<br>|
| Active Comparator: Standard infant follow-on formula<br>Infants are fed a commercial follow-on formula for 4 weeks, according to protocol | Other: Standard infant follow-on formula<br>* Infants are fed a commercial follow-on formula<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fully formula fed