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Completed

NCT Number: NCT02165956

Effect of a New Infant Cereal on Weight Gain

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 .

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Key information

Conditions

Infant Development Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

6 month–6 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Consultorio de Soto de la Marina, Soto de la Marina, Cantabria, Spain

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

New Infant Cereal

Dietary Supplement

New Infant Cereal

Standard Infant Cereal

Dietary Supplement

Standard Infant Cereal

Primary outcomes

  1. Changes in nutritional status

    Time frame: 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 outcomes

  1. Changes in appetite

    Time frame: At 6, 9, 12, 15 and 18 months of age

    Differences between groups measured by a 3-day food record.

  2. Tolerability of study product

    Time frame: 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).

  3. Changes in intestinal microbiota

    Time frame: At 6, 9, 12 and 18 months of age

    Differences between groups measured by the analysis of faecal samples.

Sponsors and collaborators

Lead sponsor

Laboratorios Ordesa

Industry

Registry information

Official study title

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

Acronym: CEOBE

Important dates

Study start
2011
Primary completion
2012
Study completion
2013
First posted
Jun 18, 2014
Registry last updated
Jul 19, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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