Acceptability, Tolerance, Satiety and Prebiotic Effect of a New Infant Cereal (ACER)
February 22, 2017 updated by: Luis Manuel Sanchez Siles, Hero Institute for Infant Nutrition
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
This study evaluates a new infant cereals on acceptability, tolerance, satiety and prebiotic effect in infants.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
46
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Murcia, Spain, 30100
- University of Murcia
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Murcia, Spain, 30120
- Hospital Virgen de la Arrixaca
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Murcia, Spain, 30010
- Quantum Experimental
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Murcia
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Alcantarilla, Murcia, Spain, 30820
- Institute Hero for Infant Nutrition
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
5 months to 6 months (CHILD)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: QUADRUPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: New Infant Cereal
amount ingested 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.
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.
|
|
ACTIVE_COMPARATOR: Multicereals Infant Cereal
amount ingested 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.
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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)
|
Day 24, day 73
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Weight
Time Frame: Day 1 (Baseline), Day 45, day 93.
|
Weight (g)
|
Day 1 (Baseline), Day 45, day 93.
|
|
Length
Time Frame: Day 1 (Baseline), Day 45, day 93.
|
Length (cm)
|
Day 1 (Baseline), Day 45, day 93.
|
|
Head Circumference
Time Frame: Day 1 (Baseline), Day 45, day 93.
|
Head Circumference (cm)
|
Day 1 (Baseline), Day 45, day 93.
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|
Gastrointestinal tolerance
Time Frame: Day 7, day 24, day 45, day 52, day 73, day 93
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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
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
|
Day 7, day 24, day 45, day 52, day 73, day 93
|
|
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
|
Day 7, day 24, day 45, day 52, day 73, day 93
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Prebiotic effects
Time Frame: Day 1 (baseline), day 45
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Microbiome sequencing- Differences between groups measured in collected stools
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Day 1 (baseline), day 45
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: David Gil, PhD, Hospital Virgen de la Arrixaca
- Study Chair: Luis M Sánchez, PhD, Hero
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
- 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.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
December 1, 2014
Primary Completion (ACTUAL)
February 1, 2017
Study Completion (ACTUAL)
February 1, 2017
Study Registration Dates
First Submitted
May 9, 2016
First Submitted That Met QC Criteria
May 19, 2016
First Posted (ESTIMATE)
May 24, 2016
Study Record Updates
Last Update Posted (ACTUAL)
February 23, 2017
Last Update Submitted That Met QC Criteria
February 22, 2017
Last Verified
February 1, 2017
More Information
Terms related to this study
Other Study ID Numbers
- CT09-14
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.