NCT02165956

Brief Summary

The purpose of this study is to determine whether a new infant cereal has an effect on weight gain and intestinal microbiota compared to a standard cereal in healthy infants .

Trial Health

87
On Track

Trial Health Score

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

Enrollment
195

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2011

Typical duration for not_applicable

Geographic Reach
1 country

5 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

March 1, 2011

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2012

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2013

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

June 11, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 18, 2014

Completed
Last Updated

July 19, 2019

Status Verified

July 1, 2019

Enrollment Period

1.1 years

First QC Date

June 11, 2014

Last Update Submit

July 17, 2019

Conditions

Infant Development

Keywords

CerealsObesityComplementary Feeding

Outcome Measures

Primary Outcomes (1)

  • Changes in nutritional status

    Difference between groups measured by a composite of nutritional parameters(weight, height, perimeters and skin fold measurements).

    At 6, 9, 12, 15 and 18 months of age

Secondary Outcomes (3)

  • Changes in appetite

    At 6, 9, 12, 15 and 18 months of age

  • Tolerability of study product

    At 6, 9, 12, 15 and 18 months of age

  • Changes in intestinal microbiota

    At 6, 9, 12 and 18 months of age

Study Arms (2)

New Infant Cereal

EXPERIMENTAL

The amount of cereal administered will be free and from 6 to 12 months of age.

Dietary Supplement: New Infant Cereal

Standard Infant Cereal

ACTIVE COMPARATOR

The amount of cereal administered will be free and from 6 to 12 months of age.

Dietary Supplement: Standard Infant Cereal

Interventions

New Infant CerealDIETARY_SUPPLEMENT

New Infant Cereal

New Infant Cereal
Standard Infant CerealDIETARY_SUPPLEMENT

Standard Infant Cereal

Standard Infant Cereal

Eligibility Criteria

Age6 Months - 6 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Lactating babies
  • months of age
  • Informed consent signed by parents

You may not qualify if:

  • Malformations, diseases or conditions that may alter development and/or nutritional status
  • Born very and extremely preterm (\<32 weeks of gestational age)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Consultorio de Soto de la Marina

Soto de la Marina, Cantabria, 39110, Spain

Location

Centro de Salud Santo Grial

Huesca, 22003, Spain

Location

Centro de Salud Perpetuo Socorro

Huesca, 22006, Spain

Location

Centro de Salud Isabel II-Centro

Santander, 39002, Spain

Location

Centro de Salud El Alisal

Santander, 39011, Spain

Location

Related Publications (3)

  • Rodríguez G, Cabero MJ, Samper P, Álvarez ML, Monje L, Morera M, Rivero M, García-Fuentes M, Moreno L. Complementary feeding and infant body composition in northern Spain. Ann Nutr Metab. 2013;63 (suppl 1):1-1960. PO908.

    RESULT

  • Rodriguez G, Cabero MJ, Morera M, Samper P, Álvarez ML, Monje L, Moreno L, García-Fuentes M, Rivero M. Intake pattern of infant complementary feeding in two populations in Northern Spain. JPGN. 2013;56(Suppl 2):486. PO-N-0283.

    RESULT

  • Morera M, Rodríguez G, Cabero MJ, Samper P, Álvarez ML, Monje L, Miralles A, Álvarez L, Rivero M, García-Fuentes M, Moreno L. Rapid weight gain during complementary feeding period and overweight risk. JPGN. 2014;58(Suppl 1):456. PO-N-0274.

    RESULT

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Luis Alberto Moreno, Professor

    Universidad de Zaragoza

    PRINCIPAL INVESTIGATOR

  • Gerardo Rodríguez, Professor

    Universidad de Zaragoza

    PRINCIPAL INVESTIGATOR

  • Mª Luisa Álvarez

    Universidad de Zaragoza

    PRINCIPAL INVESTIGATOR

  • Mª Jesús Cabero

    University of Cantabria

    PRINCIPAL INVESTIGATOR

  • Laura Monje

    University of Cantabria

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 11, 2014

First Posted

June 18, 2014

Study Start

March 1, 2011

Primary Completion

April 1, 2012

Study Completion

April 1, 2013

Last Updated

July 19, 2019

Record last verified: 2019-07

Locations

ES(5)