Growth, Healthy, Infant, Nutrition
Conditions
Keywords
Carbohydrates, Infant, Intestine, Faeces, Growth, Diet
Brief summary
The purpose of this project is to study the effect of fermentable carbohydrates in the nutrition of healthy infants.
Detailed description
Breast-fed infants have a lower occurrence of episodes of sickness compared with formula-fed infants, and this has been ascribed to their different flora composition. The purpose of this project is to study the effect of fermentable carbohydrates in the nutrition of healthy infants. Additionally, other metabolic parameters will be investigated and compared to breast-fed infants.
Interventions
DIETARY_SUPPLEMENTFermentable carbohydrates.
Infant formula enriched with fermentable carbohydrates.
OTHERStandard infant formula.
Standard infant formula.
Sponsors
Hospital Universitari Joan XXIII de Tarragona.
Hospital Universitari Sant Joan
Institut Investigacio Sanitaria Pere Virgili
University Rovira i Virgili
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
DOUBLE (Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
1 Days to 1 Months
Healthy volunteers
Yes
Inclusion criteria
* Infants born in Reus and Tarragona area * Healthy * Normal feeding behaviour
Exclusion criteria
* Serious respiratory, neurological, gastrointestinal or metabolic disorders * Infections or other serious diseases that could interfere in normal feeding or growth * Parents or guardians cannot be expected to comply with protocol * Parents or guardians have not command on Catalan or Spanish language
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Children well-being and appropriate growth | up to 4 months |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcomes will be metabolic parameters. | Up to 4 months |
Countries
Spain
Outcome results
None listed