NCT03456934

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 249 (actual)
• Sponsor: Société des Produits Nestlé (SPN) · Industry
• Sex: All
• Age: 13 Weeks – 15 Weeks
• Healthy volunteers: Accepted

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.

Conditions

• Infant Formula
• Growth

Interventions

Type	Name	Description
OTHER	Modified infant formula	Test formula with lower protein content than standard formula
OTHER	Standard infant formula	Standard infant formula

Timeline

• Start date: 2017-08-07
• Primary completion: 2021-09-30
• Completion: 2022-10-13
• First posted: 2018-03-07
• Last updated: 2023-03-17

Locations

1 site across 1 country: United Kingdom