Completed

NCT Number: NCT02781298

Acceptability, Tolerance, Satiety and Prebiotic Effect of a New Infant Cereal

This study evaluates a new infant cereals on acceptability, tolerance, satiety and prebiotic effect in infants.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Infant Nutrition Sciences

Age range

5 month–6 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institute Hero for Infant Nutrition, Alcantarilla, Murcia, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

Hedonic scale- Sensorial Evaluation

Time frame: Day 24, day 73

Sensorial acceptability -Differences between groups measured by Hedonic scales (4-points for children and 7-points for adults)

Secondary outcomes

Weight

Time frame: Day 1 (Baseline), Day 45, day 93.

Weight (g)
Length

Time frame: Day 1 (Baseline), Day 45, day 93.

Length (cm)
Head Circumference

Time frame: Day 1 (Baseline), Day 45, day 93.

Head Circumference (cm)
Gastrointestinal tolerance

Time frame: 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
Intestinal habits

Time frame: 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
Satiety

Time frame: 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

Time frame: Day 1 (baseline), day 45

Microbiome sequencing- Differences between groups measured in collected stools

Sponsors and collaborators

Lead sponsor

Hero Institute for Infant Nutrition

Industry

Collaborators

Hospital Universitario Virgen de la Arrixaca
Quantum Experimental
Universidad de Murcia

Registry information

Official study 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

Acronym: ACER

Important dates

Study start: 2014
Primary completion: 2017
Study completion: 2017
First posted: May 24, 2016
Registry last updated: Feb 23, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.