Study on Fermentable Carbohydrates in Healthy Infants
BAMBINOL
1 other identifier
interventional
388
1 country
2
Brief Summary
The purpose of this project is to study the effect of fermentable carbohydrates in the nutrition of healthy infants.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2008
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2008
CompletedFirst Submitted
Initial submission to the registry
December 15, 2008
CompletedFirst Posted
Study publicly available on registry
December 16, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2012
CompletedAugust 8, 2012
August 1, 2012
2 years
December 15, 2008
August 7, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Children well-being and appropriate growth
up to 4 months
Secondary Outcomes (1)
Secondary outcomes will be metabolic parameters.
Up to 4 months
Study Arms (3)
1: Intervention
EXPERIMENTALThis group will be fed a diet enriched with fermentable carbohydrates.
2: Placebo.
PLACEBO COMPARATORThe 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).
BF
NO INTERVENTIONThe 2 intervention groups will be compared with a breast-fed infants control group.
Interventions
Infant formula enriched with fermentable carbohydrates.
Eligibility Criteria
You may qualify if:
- Infants born in Reus and Tarragona area
- Healthy
- Normal feeding behaviour
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University Rovira i Virgililead
- Hospital Universitari Joan XXIII de Tarragona.collaborator
- Hospital Universitari Sant Joancollaborator
- Institut Investigacio Sanitaria Pere Virgilicollaborator
Study Sites (2)
Hospital Universitari Sant Joan de Reus
Reus, Tarragona, 43201, Spain
Hospital Universitari de Tarragona Joan XXIII
Tarragona, Tarragona, 43005, Spain
Related Publications (1)
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.
PMID: 23498848DERIVED
Study Officials
- PRINCIPAL INVESTIGATOR
Ricardo Closa, PhD, Prof
University Rovira i Virgili & Hospital Universitari Joan XXIII
- PRINCIPAL INVESTIGATOR
Joaquin Escribano, PhD, Prof
Universitat Rovira i Virgili. Hospital Universitari Sant Joan de Reus.
- STUDY DIRECTOR
Veronica Luque, PhD
University Rovira i Virgili
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- CARE PROVIDER, INVESTIGATOR
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Ricardo Closa Monasterolo, MD, PhD
Study Record Dates
First Submitted
December 15, 2008
First Posted
December 16, 2008
Study Start
September 1, 2008
Primary Completion
September 1, 2010
Study Completion
March 1, 2012
Last Updated
August 8, 2012
Record last verified: 2012-08