Infant Nutrition Sciences Clinical Trial
— ACEROfficial title:
Acceptability, Tolerance, Satiety and Prebiotic Effect of a New Infant Cereal in Infant Between 5 and 8 Months of Age, at the Beginning of Complementary Feeding
| Verified date | February 2017 |
| Source | Hero Institute for Infant Nutrition |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
This study evaluates a new infant cereals on acceptability, tolerance, satiety and prebiotic effect in infants.
| Status | Completed |
| Enrollment | 46 |
| Est. completion date | February 2017 |
| Est. primary completion date | February 2017 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 5 Months to 6 Months |
| Eligibility |
Inclusion Criteria: - Healthy term infant - Birth weight 2500-4200 g - Tolerance to cow's milk - Tolerance to lactose - No Breastfeeding at least 4 months of age - No use antibiotic at least 2 weeks before recruitments Exclusion Criteria: - Intolerance to gluten (celiac disease) - Congenital abnormalities - Acute diseases - Chronic situation that affect to food intake or metabolism - Breastfeeding infant - Any food allergy - Participation in other study |
| Country | Name | City | State |
|---|---|---|---|
| Spain | Institute Hero for Infant Nutrition | Alcantarilla | Murcia |
| Spain | Hospital Virgen de la Arrixaca | Murcia | |
| Spain | Quantum Experimental | Murcia | |
| Spain | University of Murcia | Murcia |
| Lead Sponsor | Collaborator |
|---|---|
| Hero Institute for Infant Nutrition | Hospital Universitario Virgen de la Arrixaca, Quantum Experimental, Universidad de Murcia |
Spain,
Bernal MJ, Periago MJ, Martínez R, Ortuño I, Sánchez-Solís M, Ros G, Romero F, Abellán 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 month — View Citation
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. Review. — View Citation
Mennella JA, Trabulsi JC. Complementary foods and flavor experiences: setting the foundation. Ann Nutr Metab. 2012;60 Suppl 2:40-50. doi: 10.1159/000335337. — View Citation
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.201 — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | |
| Secondary | Weight | Weight (g) | Day 1 (Baseline), Day 45, day 93. | |
| Secondary | Length | Length (cm) | Day 1 (Baseline), Day 45, day 93. | |
| Secondary | Head Circumference | Head Circumference (cm) | Day 1 (Baseline), Day 45, day 93. | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | Prebiotic effects | Microbiome sequencing- Differences between groups measured in collected stools | Day 1 (baseline), day 45 |