Study on Fermentable Carbohydrates in Healthy Infants

Not Applicable

Completed

• Conditions: Infant; Growth; Nutrition; Healthy
• Interventions: Dietary Supplement: Fermentable carbohydrates.; Other: Standard infant formula.

• Registration Number: NCT00808756
• Lead Sponsor: University Rovira i Virgili

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.

Study Timeline

• Study Start: 2008-09
• Study First Submitted: 2008-12-15
• Study First Submitted QC: 2008-12-15
• Study First Posted: 2008-12-16
• Primary Completion: 2010-09
• Study Completion: 2012-03
• Status Verified: 2012-08
• Last Update Submitted: 2012-08-07
• Last Update Posted: 2012-08-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 388

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1: Intervention	Fermentable carbohydrates.	This group will be fed a diet enriched with fermentable carbohydrates.
2: Placebo.	Standard infant formula.	The placebo group will be fed a diet without addition of fermentable carbohydrates. This placebo formula will have the same nutritional values than the intervention (energy, proteins, carbohydrates, fat, vitamins \& minerals).

Primary Outcome Measures

Name	Time	Method
Children well-being and appropriate growth	up to 4 months

Secondary Outcome Measures

Name	Time	Method
Secondary outcomes will be metabolic parameters.	Up to 4 months

Trial Locations

Locations (2)

Hospital Universitari de Tarragona Joan XXIII; 🇪🇸 Tarragona, Spain

Hospital Universitari Sant Joan de Reus; 🇪🇸 Reus, Tarragona, Spain