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Completed

NCT Number: NCT03456934

Lower Protein Intake and Long-term Risk of Obesity and Cardiovascular Disease

The primary objective of this study is to investigate if consumption of lower protein formula can slow the rate of weight gain of formula-fed infants between 3 and 12 months of age. Secondary objectives include investigation into whether infant nutrition and growth have an impact on later risk of obesity and cardiovascular disease.

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Key information

Conditions

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

Age range

13 week–15 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UCL Institute of Child Health

London, WC1N 1EH, United Kingdom

About this study

Obesity and its cardiovascular consequences are the most important causes of morbidity and mortality worldwide. Breastfed infants have been shown to have less cardiovascular risk factors in adulthood, which can be partially explained by their slower growth compared to formula fed infants. The primary objective of this study is to investigate if consumption of lower protein formula can slow the rate of weight gain of formula-fed infants between 3 and 12 months of age. Secondary objectives include investigation into whether infant nutrition and growth have an impact on later risk of obesity and atherosclerotic cardiovascular disease (CVD), the critical windows for these programming effects, and the mechanisms of action.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Healthy term infant
  • Infant is aged 14 weeks (+/- 1 week)
  • Infant is exclusively formula feeding or predominantly breast-feeding at age 14 weeks

Exclusion criteria

  • Any adverse maternal, fetal or infant medical history that may have effects on growth and/or development
  • Infant born with congenital disease or malformation affecting growth and/or development
  • Food allergy to any trial products (e.g. milk, soy)

Treatment and study plan

modified infant formula

Other

Test formula with lower protein content than standard formula

Standard Infant Formula

Other

Standard infant formula

Primary outcomes

  1. Infant weight gain

    Time frame: Between ages 14 weeks (+/- 1 week) and 12 months (+/- 2 weeks)

    Rate of weight gain (g/d)

Secondary outcomes

  1. Body mass index (BMI)-for-age Z-score

    Time frame: Age 2 years (+/- 1 month)

    Based on World Health Organization (WHO) growth standards

  2. Height-for-age Z-score

    Time frame: Age 2 years (+/- 1 month)

    Based on WHO growth standards

  3. Adiposity

    Time frame: Age 2 years (+/- 1 month)

    Sum of 4 skinfolds (triceps, biceps, sub-scapular, supra-iliac)

  4. Fat mass

    Time frame: Age 2 years (+/- 1 month)

    Deuterium dilution (assessed in subset)

Other outcomes

  1. Infant weight gain

    Time frame: Between 6 and 12 months

    Rate of weight gain (g/d)

  2. Weight

    Time frame: Ages 4, 5, 6, 12 and 24 months

    Body weight (kg)

  3. Length or height

    Time frame: Ages 4, 5, 6, 12 and 24 months

    Length or height (cm)

  4. Head circumference

    Time frame: Ages 4, 5, 6, 12 and 24 months

    Head circumference (cm)

  5. Body mass index

    Time frame: Ages 6, 12 and 24 months

    Weight and length or height will be combined to report BMI in kg/m^2

  6. Weight-for-age Z-score

    Time frame: Ages 14 weeks and 4, 5, 6, 12 and 24 months

    Based on WHO growth standards

  7. Weight-for-length Z-score

    Time frame: Ages 14 weeks and 4, 5, 6, 12 and 24 months

    Based on WHO growth standards

  8. Height-for-age Z-score

    Time frame: Ages 14 weeks and 4, 5, 6, and 12 months

    Based on WHO growth standards

  9. BMI-for-age Z-score

    Time frame: Ages 14 weeks and 4, 5, 6, and 12 months

    Based on WHO growth standards

  10. Adverse events

    Time frame: Ages 14 weeks and 4, 5, 6, 9, 12 and 24 months

    Safety

  11. Feeding intake

    Time frame: Ages 14 weeks and 4, 5, 6, and 12 months

    Infant feeding questionnaire

  12. Feeding tolerance

    Time frame: Ages 14 weeks and 4, 5, 6, and 12 months

    GI symptom and stool pattern questionnaire

  13. Metabolic markers of cardiovascular health

    Time frame: Ages 6 and 12 months

    Blood sample (in a subset)

  14. Blood pressure

    Time frame: At age 12 and 24 months

    Systolic and diastolic blood pressure (in a subset)

  15. Appetite and feeding / eating behavior

    Time frame: Ages 14 weeks and 4, 5, 6, and 24 months

    Baby and Children's Eating Behavior Questionnaire

Sponsors and collaborators

Lead sponsor

Société des Produits Nestlé (SPN)

Industry

Collaborators

  • University College, London

Registry information

Official study title

Lower Protein Intake and Long-term Risk of Obesity and Cardiovascular Disease: A Multi-centred, Randomised, Controlled Trial

Acronym: BabyGrowth

Important dates

Study start
2017
Primary completion
2021
Study completion
2022
First posted
Mar 7, 2018
Registry last updated
Mar 17, 2023

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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