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| Name | Class |
|---|---|
| Universidad de Murcia | OTHER |
| Hospital Universitario Virgen de la Arrixaca | OTHER |
| Quantum Experimental | UNKNOWN |
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This study evaluates a new infant cereals on acceptability, tolerance, satiety and prebiotic effect in infants.
This is a controlled, randomized, prospective, crossover, triple-blind study to evaluate of a new infant cereal with a portion of whole grain flour on sensorial acceptability, gastrointestinal tolerance, satiety and prebiotic effect in healthy infants fron 5 to 8 months of age at the beginning of complementary feeding.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| New Infant Cereal | Experimental | amount ingested according to pediatricians recommendations |
|
| Multicereals Infant Cereal | Active Comparator | amount ingested according to pediatricians recommendations |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| New Infant Cereal | Dietary Supplement | The infants will start the complementary feeding with the infants cereals of this study, the amount of cereal ingested will be free according to pediatricians recommendations. |
| Measure | Description | Time Frame |
|---|---|---|
| Hedonic scale- Sensorial Evaluation | Sensorial acceptability -Differences between groups measured by Hedonic scales (4-points for children and 7-points for adults) | Day 24, day 73 |
| Measure | Description | Time Frame |
|---|---|---|
| Weight | Weight (g) | Day 1 (Baseline), Day 45, day 93. |
| Length | Length (cm) | Day 1 (Baseline), Day 45, day 93. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David Gil, PhD | Hospital Virgen de la Arrixaca | Principal Investigator |
| Luis M Sánchez, PhD | Hero | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute Hero for Infant Nutrition | Alcantarilla | Murcia | 30820 | Spain | ||
| Quantum Experimental |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23812516 | Result | Bernal MJ, Periago MJ, Martinez R, Ortuno I, Sanchez-Solis M, Ros G, Romero F, Abellan P. Effects of infant cereals with different carbohydrate profiles on colonic function--randomised and double-blind clinical trial in infants aged between 6 and 12 months--pilot study. Eur J Pediatr. 2013 Nov;172(11):1535-42. doi: 10.1007/s00431-013-2079-3. Epub 2013 Jun 29. | |
| 20565994 |
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| Multicereals Infant Cereal | Dietary Supplement | The infants will start the complementary feeding with the infants cereals of this study, the amount of cereal ingested will be free according to pediatricians recommendations. |
|
| Head Circumference | Head Circumference (cm) | Day 1 (Baseline), Day 45, day 93. |
| Gastrointestinal tolerance | Numbers of Regurgitations, gassiness, rejections- Differences between groups measured by a 1-day record | Day 7, day 24, day 45, day 52, day 73, day 93 |
| Intestinal habits | Frequency of defecations and stools consistency- Differences between groups measured by 1-day record | Day 7, day 24, day 45, day 52, day 73, day 93 |
| Satiety | Food intake (amount), crying (time) and sleeping (time)-Differences between groups measured by 1-day record | Day 7, day 24, day 45, day 52, day 73, day 93 |
| Prebiotic effects | Microbiome sequencing- Differences between groups measured in collected stools | Day 1 (baseline), day 45 |
| Murcia |
| Murcia |
| 30010 |
| Spain |
| University of Murcia | Murcia | Murcia | 30100 | Spain |
| Hospital Virgen de la Arrixaca | Murcia | Murcia | 30120 | Spain |
| Fardet A. New hypotheses for the health-protective mechanisms of whole-grain cereals: what is beyond fibre? Nutr Res Rev. 2010 Jun;23(1):65-134. doi: 10.1017/S0954422410000041. Epub 2010 Jun 22. |
| 22473042 | Result | Stephen A, Alles M, de Graaf C, Fleith M, Hadjilucas E, Isaacs E, Maffeis C, Zeinstra G, Matthys C, Gil A. The role and requirements of digestible dietary carbohydrates in infants and toddlers. Eur J Clin Nutr. 2012 Jul;66(7):765-79. doi: 10.1038/ejcn.2012.27. Epub 2012 Apr 4. |
| 22555188 | Result | Mennella JA, Trabulsi JC. Complementary foods and flavor experiences: setting the foundation. Ann Nutr Metab. 2012;60 Suppl 2(Suppl 2):40-50. doi: 10.1159/000335337. Epub 2012 Apr 27. |