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

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

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.

Study Overview

• Status: Completed
• Conditions: Growth; Infant Formula
• Intervention / Treatment: Other: Standard infant formula; Other: Modified infant formula

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 249
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • London, United Kingdom, WC1N 1EH
    • UCL Institute of Child Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 months to 3 months (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental Group; Modified infant formula given from 3 to 12 months of age, as per standard requirement.	Other: Modified infant formula; Test formula with lower protein content than standard formula
Active Comparator: Control Group; Standard infant formula given from 3 to 12 months of age, as per standard requirement.	Other: Standard infant formula; Standard infant formula
No Intervention: Breast-fed Reference Group; Non-randomized infants who are predominantly breast-fed at time of enrollment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Infant weight gain	Rate of weight gain (g/d)	Between ages 14 weeks (+/- 1 week) and 12 months (+/- 2 weeks)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Body mass index (BMI)-for-age Z-score	Based on World Health Organization (WHO) growth standards	Age 2 years (+/- 1 month)
Height-for-age Z-score	Based on WHO growth standards	Age 2 years (+/- 1 month)
Adiposity	Sum of 4 skinfolds (triceps, biceps, sub-scapular, supra-iliac)	Age 2 years (+/- 1 month)
Fat mass	Deuterium dilution (assessed in subset)	Age 2 years (+/- 1 month)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Infant weight gain	Rate of weight gain (g/d)	Between 6 and 12 months
Weight	Body weight (kg)	Ages 4, 5, 6, 12 and 24 months
Length or height	Length or height (cm)	Ages 4, 5, 6, 12 and 24 months
Head circumference	Head circumference (cm)	Ages 4, 5, 6, 12 and 24 months
Body mass index	Weight and length or height will be combined to report BMI in kg/m^2	Ages 6, 12 and 24 months
Weight-for-age Z-score	Based on WHO growth standards	Ages 14 weeks and 4, 5, 6, 12 and 24 months
Weight-for-length Z-score	Based on WHO growth standards	Ages 14 weeks and 4, 5, 6, 12 and 24 months
Height-for-age Z-score	Based on WHO growth standards	Ages 14 weeks and 4, 5, 6, and 12 months
BMI-for-age Z-score	Based on WHO growth standards	Ages 14 weeks and 4, 5, 6, and 12 months
Adverse events	Safety	Ages 14 weeks and 4, 5, 6, 9, 12 and 24 months
Feeding intake	Infant feeding questionnaire	Ages 14 weeks and 4, 5, 6, and 12 months
Feeding tolerance	GI symptom and stool pattern questionnaire	Ages 14 weeks and 4, 5, 6, and 12 months
Metabolic markers of cardiovascular health	Blood sample (in a subset)	Ages 6 and 12 months
Blood pressure	Systolic and diastolic blood pressure (in a subset)	At age 12 and 24 months
Appetite and feeding / eating behavior	Baby and Children's Eating Behavior Questionnaire	Ages 14 weeks and 4, 5, 6, and 24 months

Collaborators and Investigators

• Sponsor: Société des Produits Nestlé (SPN)
• Collaborators: University College, London
• Investigators: Principal Investigator: Atul Singhal, MD, Childhood Nutrition Research Centre, University College London, Institute of Child Health

Study record dates

Study Major Dates

• Study Start (Actual): August 7, 2017
• Primary Completion (Actual): September 30, 2021
• Study Completion (Actual): October 13, 2022

Study Registration Dates

• First Submitted: February 22, 2018
• First Submitted That Met QC Criteria: March 5, 2018
• First Posted (Actual): March 7, 2018

Study Record Updates

• Last Update Posted (Actual): March 17, 2023
• Last Update Submitted That Met QC Criteria: March 16, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: Body composition; Protein requirements; Adiposity; Cardiovascular health
• Additional Relevant MeSH Terms: Cardiovascular Diseases
• Other Study ID Numbers: 15.09.INF

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No