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| Name | Class |
|---|---|
| Hospital Universitari Joan XXIII de Tarragona. | OTHER |
| Hospital Universitari Sant Joan | UNKNOWN |
| Institut Investigacio Sanitaria Pere Virgili | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1: Intervention | Experimental | This group will be fed a diet enriched with fermentable carbohydrates. |
|
| 2: Placebo. | Placebo Comparator | 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). |
|
| BF | No Intervention | The 2 intervention groups will be compared with a breast-fed infants control group. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fermentable carbohydrates. | Dietary Supplement | Infant formula enriched with fermentable carbohydrates. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Children well-being and appropriate growth | up to 4 months |
| Measure | Description | Time Frame |
|---|---|---|
| Secondary outcomes will be metabolic parameters. | Up to 4 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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. | Principal Investigator |
| Veronica Luque, PhD | University Rovira i Virgili | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitari Sant Joan de Reus | Reus | Tarragona | 43201 | Spain | ||
| Hospital Universitari de Tarragona Joan XXIII |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23498848 | Derived | 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. |
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| Standard infant formula. | Other | Standard infant formula. |
|
| Tarragona |
| Tarragona |
| 43005 |
| Spain |