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The purpose of this study is to determine whether a new infant cereal has an effect on weight gain and intestinal microbiota compared to a standard cereal in healthy infants .
This is a multicenter, controlled, randomized, prospective, parallel-group, double-blind study to evaluate the effect of a new infant cereal supplemented with prebiotics, probiotics, vegetable proteins and a special blend of starches on weight gain and intestinal microbiota in healthy infants from 6 to 12 moths of age. Patients will be randomized to receive either the new infant cereal or a standard cereal.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| New Infant Cereal | Experimental | The amount of cereal administered will be free and from 6 to 12 months of age. |
|
| Standard Infant Cereal | Active Comparator | The amount of cereal administered will be free and from 6 to 12 months of age. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| New Infant Cereal | Dietary Supplement | New Infant Cereal |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in nutritional status | Difference between groups measured by a composite of nutritional parameters(weight, height, perimeters and skin fold measurements). | At 6, 9, 12, 15 and 18 months of age |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in appetite | Differences between groups measured by a 3-day food record. | At 6, 9, 12, 15 and 18 months of age |
| Tolerability of study product | Differences between groups measured by frequency and type of a composite of gastrointestinal symptoms (regurgitation, irritability, flatulence and crying). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Luis Alberto Moreno, Professor | Universidad de Zaragoza | Principal Investigator |
| Gerardo Rodríguez, Professor | Universidad de Zaragoza | Principal Investigator |
| Mª Luisa Álvarez | Universidad de Zaragoza | Principal Investigator |
| Mª Jesús Cabero | University of Cantabria | Principal Investigator |
| Laura Monje | University of Cantabria | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Consultorio de Soto de la Marina | Soto de la Marina | Cantabria | 39110 | Spain | ||
| Centro de Salud Santo Grial |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Result | Rodríguez G, Cabero MJ, Samper P, Álvarez ML, Monje L, Morera M, Rivero M, García-Fuentes M, Moreno L. Complementary feeding and infant body composition in northern Spain. Ann Nutr Metab. 2013;63 (suppl 1):1-1960. PO908. | ||
| Result | Rodriguez G, Cabero MJ, Morera M, Samper P, Álvarez ML, Monje L, Moreno L, García-Fuentes M, Rivero M. Intake pattern of infant complementary feeding in two populations in Northern Spain. JPGN. 2013;56(Suppl 2):486. PO-N-0283. | ||
| Result | Morera M, Rodríguez G, Cabero MJ, Samper P, Álvarez ML, Monje L, Miralles A, Álvarez L, Rivero M, García-Fuentes M, Moreno L. Rapid weight gain during complementary feeding period and overweight risk. JPGN. 2014;58(Suppl 1):456. PO-N-0274. |
| Label | URL |
|---|---|
| ESPGHAN 2014 Annual Meeting - Abstracts Book - JPGN. 2014;58(Suppl 1):456. | View source |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| Standard Infant Cereal |
| Dietary Supplement |
Standard Infant Cereal |
|
| At 6, 9, 12, 15 and 18 months of age |
| Changes in intestinal microbiota | Differences between groups measured by the analysis of faecal samples. | At 6, 9, 12 and 18 months of age |
| Huesca |
| 22003 |
| Spain |
| Centro de Salud Perpetuo Socorro | Huesca | 22006 | Spain |
| Centro de Salud Isabel II-Centro | Santander | 39002 | Spain |
| Centro de Salud El Alisal | Santander | 39011 | Spain |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |