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OpenTrials
Completed

NCT Number: NCT00820833

Effect of Formula on Growth of Infants From Overweight or Obese Mothers

The purpose of this study is to determine whether infants, from overweight or obese mothers, fed a formula with proteins and calories different than a standard infant formula have a different growth

Completed

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Key information

Conditions

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

Age range

3 month–12 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Departamento de Medicina Interna, University de la Frontera

Temuco, Chile

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • healthy newborn infant
  • birth weight between 2500g and 4800g
  • singleton birth
  • mother's BMI before pregnancy was between 26 and 25
  • for the breastfeeding group: mother has elected to exclusively breastfeed her baby from birth to at least 6 months of age
  • for the formula groups: mother has elected to exclusively formula feed her baby from 3 to 6 months of age
  • having obtained signed informed consent of legal representative

Exclusion criteria

  • body weight smaller than 5th percentile for that gestational age
  • newborn whose mother has diabetes
  • newborn whose mother has a drug dependence during pregnancy
  • newborn currently participating in another trial

Treatment and study plan

Standard Infant Formula

Other

standard infant formula given from 3 to 12 months of age, as per standard requirement

Test formula

Other

Test formula with different protein and calorie content than standard formula, given from 3 to 12 months of age. As per standard requirement.

Primary outcomes

  1. mean weight gain

    Time frame: 3 months

Secondary outcomes

  1. blood test assessments; body composition, bone density

    Time frame: 9 months

Sponsors and collaborators

Lead sponsor

Société des Produits Nestlé (SPN)

Industry

Registry information

Official study title

Effect of Protein Levels and Caloric Density on the Growth of Formula Fed Infants From Overweight or Obese Mothers

Important dates

Study start
2007
Primary completion
2010
Study completion
2014
First posted
Jan 12, 2009
Registry last updated
Mar 26, 2015

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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