Infant Nutrition Sciences
Conditions
Brief summary
This study evaluates a new infant cereals on acceptability, tolerance, satiety and prebiotic effect in infants.
Detailed description
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.
Interventions
DIETARY_SUPPLEMENTNew Infant Cereal
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.
DIETARY_SUPPLEMENTMulticereals Infant Cereal
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.
Sponsors
Universidad de Murcia
Hospital Universitario Virgen de la Arrixaca
Quantum Experimental
Hero Institute for Infant Nutrition
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
5 Months to 6 Months
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hedonic scale- Sensorial Evaluation | Day 24, day 73 | Sensorial acceptability -Differences between groups measured by Hedonic scales (4-points for children and 7-points for adults) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Length | Day 1 (Baseline), Day 45, day 93. | Length (cm) |
| Head Circumference | Day 1 (Baseline), Day 45, day 93. | Head Circumference (cm) |
| Gastrointestinal tolerance | Day 7, day 24, day 45, day 52, day 73, day 93 | Numbers of Regurgitations, gassiness, rejections- Differences between groups measured by a 1-day record |
| Weight | Day 1 (Baseline), Day 45, day 93. | Weight (g) |
| Satiety | Day 7, day 24, day 45, day 52, day 73, day 93 | Food intake (amount), crying (time) and sleeping (time)-Differences between groups measured by 1-day record |
| Prebiotic effects | Day 1 (baseline), day 45 | Microbiome sequencing- Differences between groups measured in collected stools |
| Intestinal habits | Day 7, day 24, day 45, day 52, day 73, day 93 | Frequency of defecations and stools consistency- Differences between groups measured by 1-day record |
Countries
Spain
Outcome results
None listed