Effect of a New Infant Cereal on Weight Gain

Effect of a New Food Product on Weight Gain During First Infancy

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02165956

Acronym

CEOBE

Enrollment

195

Registered

2014-06-18

Start date

2011-03-31

Completion date

2013-04-30

Last updated

2019-07-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infant Development

Keywords

Cereals, Obesity, Complementary Feeding

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 .

Detailed description

This is a multicenter, controlled, randomized, prospective, parallel-group, double-blind study to evaluate the effect of a new infant cereal supplemented with prebiotics, probiotics, vegetable proteins and a special blend of starches on weight gain and intestinal microbiota in healthy infants from 6 to 12 moths of age. Patients will be randomized to receive either the new infant cereal or a standard cereal.

Interventions

DIETARY_SUPPLEMENTNew Infant Cereal

New Infant Cereal

DIETARY_SUPPLEMENTStandard Infant Cereal

Standard Infant Cereal

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

OTHER

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

6 Months to 6 Months

Healthy volunteers

Yes

Inclusion criteria

* Lactating babies * 6 months of age * Informed consent signed by parents

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame	Description
Changes in nutritional status	At 6, 9, 12, 15 and 18 months of age	Difference between groups measured by a composite of nutritional parameters(weight, height, perimeters and skin fold measurements).

Secondary

Measure	Time frame	Description
Changes in appetite	At 6, 9, 12, 15 and 18 months of age	Differences between groups measured by a 3-day food record.
Tolerability of study product	At 6, 9, 12, 15 and 18 months of age	Differences between groups measured by frequency and type of a composite of gastrointestinal symptoms (regurgitation, irritability, flatulence and crying).
Changes in intestinal microbiota	At 6, 9, 12 and 18 months of age	Differences between groups measured by the analysis of faecal samples.

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026