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Study on Fermentable Carbohydrates in Healthy Infants

NCT ID: NCT00808756

Last Updated: 2012-08-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

388 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-09-30

Study Completion Date

2012-03-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Infant Growth Nutrition Healthy

Keywords

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Carbohydrates Infant Intestine Faeces Growth Diet

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

DOUBLE

Caregivers Investigators

Study Groups

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1: Intervention

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

Group Type EXPERIMENTAL

Fermentable carbohydrates.

Intervention Type DIETARY_SUPPLEMENT

Infant formula enriched with fermentable carbohydrates.

2: Placebo.

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).

Group Type PLACEBO_COMPARATOR

Standard infant formula.

Intervention Type OTHER

Standard infant formula.

BF

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Fermentable carbohydrates.

Infant formula enriched with fermentable carbohydrates.

Intervention Type DIETARY_SUPPLEMENT

Standard infant formula.

Standard infant formula.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

1 Day

Maximum Eligible Age

1 Month

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Hospital Universitari Joan XXIII de Tarragona.

OTHER

Sponsor Role collaborator

Hospital Universitari Sant Joan

UNKNOWN

Sponsor Role collaborator

Institut Investigacio Sanitaria Pere Virgili

OTHER

Sponsor Role collaborator

University Rovira i Virgili

OTHER

Sponsor Role lead

Responsible Party

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Ricardo Closa-Monasterolo

Ricardo Closa Monasterolo, MD, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ricardo Closa, PhD, Prof

Role: PRINCIPAL_INVESTIGATOR

University Rovira i Virgili & Hospital Universitari Joan XXIII

Joaquin Escribano, PhD, Prof

Role: PRINCIPAL_INVESTIGATOR

Universitat Rovira i Virgili. Hospital Universitari Sant Joan de Reus.

Veronica Luque, PhD

Role: STUDY_DIRECTOR

University Rovira i Virgili

Locations

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Hospital Universitari Sant Joan de Reus

Reus, Tarragona, Spain

Site Status

Hospital Universitari de Tarragona Joan XXIII

Tarragona, Tarragona, Spain

Site Status

Countries

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Spain

References

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Closa-Monasterolo R, Gispert-Llaurado M, Luque V, Ferre N, Rubio-Torrents C, Zaragoza-Jordana M, Escribano J. Safety and efficacy of inulin and oligofructose supplementation in infant formula: results from a randomized clinical trial. Clin Nutr. 2013 Dec;32(6):918-27. doi: 10.1016/j.clnu.2013.02.009. Epub 2013 Feb 26.

Reference Type DERIVED
PMID: 23498848 (View on PubMed)

Other Identifiers

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BAMBINOL

Identifier Type: -

Identifier Source: org_study_id