NCT02781298

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
46

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2014

Typical duration for not_applicable

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2014

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

May 9, 2016

Completed
15 days until next milestone

First Posted

Study publicly available on registry

May 24, 2016

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2017

Completed
Last Updated

February 23, 2017

Status Verified

February 1, 2017

Enrollment Period

2.2 years

First QC Date

May 9, 2016

Last Update Submit

February 22, 2017

Conditions

Infant Nutrition Sciences

Outcome Measures

Primary Outcomes (1)

  • Hedonic scale- Sensorial Evaluation

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

    Day 24, day 73

Secondary Outcomes (7)

  • Weight

    Day 1 (Baseline), Day 45, day 93.

  • Length

    Day 1 (Baseline), Day 45, day 93.

  • Head Circumference

    Day 1 (Baseline), Day 45, day 93.

  • Gastrointestinal tolerance

    Day 7, day 24, day 45, day 52, day 73, day 93

  • Intestinal habits

    Day 7, day 24, day 45, day 52, day 73, day 93

  • +2 more secondary outcomes

Study Arms (2)

New Infant Cereal

EXPERIMENTAL

amount ingested according to pediatricians recommendations

Dietary Supplement: New Infant CerealDietary Supplement: Multicereals Infant Cereal

Multicereals Infant Cereal

ACTIVE COMPARATOR

amount ingested according to pediatricians recommendations

Dietary Supplement: New Infant CerealDietary Supplement: Multicereals Infant Cereal

Interventions

New Infant CerealDIETARY_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 CerealNew Infant Cereal
Multicereals Infant CerealDIETARY_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 CerealNew Infant Cereal

Eligibility Criteria

Age5 Months - 6 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Institute Hero for Infant Nutrition

Alcantarilla, Murcia, 30820, Spain

Location

Quantum Experimental

Murcia, Murcia, 30010, Spain

Location

University of Murcia

Murcia, Murcia, 30100, Spain

Location

Hospital Virgen de la Arrixaca

Murcia, Murcia, 30120, Spain

Location

Related Publications (4)

  • 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.

    PMID: 23812516RESULT

  • 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.

    PMID: 20565994RESULT

  • 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.

    PMID: 22473042RESULT

  • 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.

    PMID: 22555188RESULT

Related Links

Study Officials

  • David Gil, PhD

    Hospital Virgen de la Arrixaca

    PRINCIPAL INVESTIGATOR

  • Luis M Sánchez, PhD

    Hero

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director Innovation Infant Nutrition

Study Record Dates

First Submitted

May 9, 2016

First Posted

May 24, 2016

Study Start

December 1, 2014

Primary Completion

February 1, 2017

Study Completion

February 1, 2017

Last Updated

February 23, 2017

Record last verified: 2017-02

Data Sharing

IPD Sharing
Will not share

Locations

ES(4)