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

Not Applicable

Completed

• Conditions: Infant Formula; Growth
• Interventions: Other: Standard infant formula; Other: Modified infant formula

• Registration Number: NCT03456934
• Lead Sponsor: Société des Produits Nestlé (SPN)

Brief 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.

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 Timeline

• Study Start: 2017-08-07
• Study First Submitted: 2018-02-22
• Study First Submitted QC: 2018-03-05
• Study First Posted: 2018-03-07
• Primary Completion: 2021-09-30
• Study Completion: 2022-10-13
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-16
• Last Update Posted: 2023-03-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 249

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control Group	Standard infant formula	Standard infant formula given from 3 to 12 months of age, as per standard requirement.
Experimental Group	Modified infant formula	Modified infant formula given from 3 to 12 months of age, as per standard requirement.

Primary Outcome Measures

Name	Time	Method
Infant weight gain	Between ages 14 weeks (+/- 1 week) and 12 months (+/- 2 weeks)	Rate of weight gain (g/d)

Secondary Outcome Measures

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

Trial Locations

Locations (1)

UCL Institute of Child Health; 🇬🇧 London, United Kingdom