An interventional study of New Infant Cereal and Multicereals Infant Cereal in Infant Nutrition Sciences, sponsored by Hero Institute for Infant Nutrition. Completed at 4 sites in Spain. Open to participants aged 5 Months to 6 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-02-23.
Sponsored by Hero Institute for Infant Nutrition · Not applicable, Interventional, and Treatment
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.
Hero Institute for Infant Nutrition is the lead sponsor of 2 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
amount ingested according to pediatricians recommendations
Dietary Supplement: New Infant Cereal · Dietary Supplement: Multicereals Infant Cereal
amount ingested according to pediatricians recommendations
Dietary Supplement: New Infant Cereal · Dietary Supplement: Multicereals 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.
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.
Hedonic scale- Sensorial Evaluation
Sensorial acceptability -Differences between groups measured by Hedonic scales (4-points for children and 7-points for adults)
Time frame: Day 24, day 73
Weight
Weight (g)
Time frame: Day 1 (Baseline), Day 45, day 93.
Length
Length (cm)
Time frame: Day 1 (Baseline), Day 45, day 93.
Head Circumference
Head Circumference (cm)
Time frame: Day 1 (Baseline), Day 45, day 93.
Gastrointestinal tolerance
Numbers of Regurgitations, gassiness, rejections- Differences between groups measured by a 1-day record
Time frame: 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
Time frame: 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
Time frame: Day 7, day 24, day 45, day 52, day 73, day 93
Prebiotic effects
Microbiome sequencing- Differences between groups measured in collected stools
Time frame: Day 1 (baseline), day 45
Plan to share: No
This study is completed, as verified in Feb 2017. You cannot join it, but the record below documents what was studied.
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Hero Institute for Infant Nutrition