Study on Fermentable Carbohydrates in Healthy Infants (BAMBINOL)

University Rovira i Virgili

Status: Completed

Conditions: Healthy; Nutrition; Infant; Growth

Treatments: Dietary Supplement: Fermentable carbohydrates.; Other: Standard infant formula.

Study type: Interventional

Funder types: Other

Identifiers

NCT00808756

BAMBINOL

Details and patient eligibility

About

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

Full 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.

Enrollment: 388 patients

Sex: All

Ages: 1 day to 1 month old

Volunteers: Accepts Healthy Volunteers

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

Trial design

388 participants in 3 patient groups, including a placebo group

1: Intervention

Experimental group

Description:

This group will be fed a diet enriched with fermentable carbohydrates.

Treatment:

Dietary Supplement: Fermentable carbohydrates.

2: Placebo.

Placebo Comparator group

Description:

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).

Treatment:

Other: Standard infant formula.

BF

No Intervention group

Description:

The 2 intervention groups will be compared with a breast-fed infants control group.