We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02781298
First Posted: May 24, 2016
Last Update Posted: February 23, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Universidad de Murcia
Hospital Universitario Virgen de la Arrixaca
Quantum Experimental
Information provided by (Responsible Party):
Luis Manuel Sanchez Siles, Hero Institute for Infant Nutrition
  Purpose
This study evaluates a new infant cereals on acceptability, tolerance, satiety and prebiotic effect in infants.

Condition Intervention
Infant Nutrition Sciences Dietary Supplement: New Infant Cereal Dietary Supplement: Multicereals Infant Cereal

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:


Further study details as provided by Luis Manuel Sanchez Siles, Hero Institute for Infant Nutrition:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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


Enrollment: 46
Actual Study Start Date: December 2014
Study Completion Date: February 2017
Primary Completion Date: February 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: New Infant Cereal
amount ingested according to pediatricians recommendations
Dietary Supplement: New 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 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.
Active Comparator: Multicereals Infant Cereal
amount ingested according to pediatricians recommendations
Dietary Supplement: New 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 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.

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.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   5 Months to 6 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02781298


Locations
Spain
Institute Hero for Infant Nutrition
Alcantarilla, Murcia, Spain, 30820
Quantum Experimental
Murcia, Spain, 30010
University of Murcia
Murcia, Spain, 30100
Hospital Virgen de la Arrixaca
Murcia, Spain, 30120
Sponsors and Collaborators
Hero Institute for Infant Nutrition
Universidad de Murcia
Hospital Universitario Virgen de la Arrixaca
Quantum Experimental
Investigators
Principal Investigator: David Gil, PhD Hospital Virgen de la Arrixaca
Study Chair: Luis M Sánchez, PhD Hero
  More Information

Additional Information:
Publications:
Responsible Party: Luis Manuel Sanchez Siles, Director Innovation Infant Nutrition, Hero Institute for Infant Nutrition
ClinicalTrials.gov Identifier: NCT02781298     History of Changes
Other Study ID Numbers: CT09-14
First Submitted: May 9, 2016
First Posted: May 24, 2016
Last Update Posted: February 23, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No