Study on Fermentable Carbohydrates in Healthy Infants

University Rovira i Virgili388 enrolled

Overview

The purpose of this project is to study the effect of fermentable carbohydrates in the nutrition of healthy infants.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Masking

DOUBLE

Enrollment

388

Conditions

Infant Growth Nutrition Healthy

Interventions

Fermentable carbohydrates.DIETARY_SUPPLEMENT

Infant formula enriched with fermentable carbohydrates.

Standard infant formula.OTHER

Standard infant formula.

Eligibility

Sex: ALLMin age: 1 DayMax age: 1 MonthHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (2)

Hospital Universitari Sant Joan de Reus

Reus, Tarragona, Spain

Hospital Universitari de Tarragona Joan XXIII

Tarragona, Tarragona, Spain

Outcomes

Primary Outcomes

Children well-being and appropriate growth

Time frame: up to 4 months

Secondary Outcomes

Secondary outcomes will be metabolic parameters.

Time frame: Up to 4 months

Data from ClinicalTrials.gov

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