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

Growth Clinical Trial

— BabyGrowth  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03456934
• Other study ID #: 15.09.INF
• Status: Completed
• Phase: N/A
• Start date: August 7, 2017
• Est. completion date: October 13, 2022

Study information

• Verified date: March 2023
• Source: Société des Produits Nestlé (SPN)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 249
• Est. completion date: October 13, 2022
• Est. primary completion date: September 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 13 Weeks to 15 Weeks

Eligibility

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)

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Growth
• Infant Formula

Intervention

Other:
• Modified infant formula
Test formula with lower protein content than standard formula
• Standard infant formula
Standard infant formula

Locations

Country	Name	City	State
United Kingdom	UCL Institute of Child Health	London

Sponsors (2)

Lead Sponsor	Collaborator
Société des Produits Nestlé (SPN)	University College, London

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Infant weight gain	Rate of weight gain (g/d)	Between 6 and 12 months
Other	Weight	Body weight (kg)	Ages 4, 5, 6, 12 and 24 months
Other	Length or height	Length or height (cm)	Ages 4, 5, 6, 12 and 24 months
Other	Head circumference	Head circumference (cm)	Ages 4, 5, 6, 12 and 24 months
Other	Body mass index	Weight and length or height will be combined to report BMI in kg/m^2	Ages 6, 12 and 24 months
Other	Weight-for-age Z-score	Based on WHO growth standards	Ages 14 weeks and 4, 5, 6, 12 and 24 months
Other	Weight-for-length Z-score	Based on WHO growth standards	Ages 14 weeks and 4, 5, 6, 12 and 24 months
Other	Height-for-age Z-score	Based on WHO growth standards	Ages 14 weeks and 4, 5, 6, and 12 months
Other	BMI-for-age Z-score	Based on WHO growth standards	Ages 14 weeks and 4, 5, 6, and 12 months
Other	Adverse events	Safety	Ages 14 weeks and 4, 5, 6, 9, 12 and 24 months
Other	Feeding intake	Infant feeding questionnaire	Ages 14 weeks and 4, 5, 6, and 12 months
Other	Feeding tolerance	GI symptom and stool pattern questionnaire	Ages 14 weeks and 4, 5, 6, and 12 months
Other	Metabolic markers of cardiovascular health	Blood sample (in a subset)	Ages 6 and 12 months
Other	Blood pressure	Systolic and diastolic blood pressure (in a subset)	At age 12 and 24 months
Other	Appetite and feeding / eating behavior	Baby and Children's Eating Behavior Questionnaire	Ages 14 weeks and 4, 5, 6, and 24 months
Primary	Infant weight gain	Rate of weight gain (g/d)	Between ages 14 weeks (+/- 1 week) and 12 months (+/- 2 weeks)
Secondary	Body mass index (BMI)-for-age Z-score	Based on World Health Organization (WHO) growth standards	Age 2 years (+/- 1 month)
Secondary	Height-for-age Z-score	Based on WHO growth standards	Age 2 years (+/- 1 month)
Secondary	Adiposity	Sum of 4 skinfolds (triceps, biceps, sub-scapular, supra-iliac)	Age 2 years (+/- 1 month)
Secondary	Fat mass	Deuterium dilution (assessed in subset)	Age 2 years (+/- 1 month)