Clinical Trials Directory

Trials / Completed

CompletedNCT04332510

A Study to Investigate the Effect of Protein in Infant Formula on Insulin Response in Adults

Acute Metabolic Effect of Different Infant Formulas (Intact Protein, Partially Hydrolyzed Protein and High Level of Partially Hydrolyzed Protein) and Breast Milk in Healthy Adults

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
35 (actual)
Sponsor
Société des Produits Nestlé (SPN) · Industry
Sex
All
Age
20 Years – 50 Years
Healthy volunteers
Accepted

Summary

It has been established that the consumption of a diet that causes a low rise in blood insulin levels is beneficial in terms of risk for diabetes and heart disease. Furthermore, it is known that certain nutrients contained within a food play an important role in the insulin response of that food. For example, the type and quantity of protein has been shown to affect the insulin response to particular foods. Different types of infant formula exist, containing different levels and types of protein, yet the impact of these different infant formulas on blood insulin levels is not known. Using a randomized, double blind, cross-over study design, the insulin response to four test milks was compared in healthy adults. The four test milks were as follows: i) infant formula containing partially hydrolyzed protein; ii) infant formula with intact protein; (iii) infant formula with a higher energy and protein content compared to (i) and (ii); and (iv) human breast milk (in a small sub-group). The aim of the study was to show that the insulin response to the partially hydrolyzed formula is similar to that of an infant formula with intact protein.

Conditions

Interventions

TypeNameDescription
OTHERIntact formula600 ml of infant formula with intact protein
OTHERPartially hydrolyzed formula600 ml of infant formula with partially hydrolyzed protein
OTHERHigh protein formula600 ml of infant formula with high protein level
OTHERHuman breast milk600 ml of breast milk, safe for human consumption

Timeline

Start date
2012-06-01
Primary completion
2013-06-01
Completion
2013-06-01
First posted
2020-04-02
Last updated
2020-04-02

Source: ClinicalTrials.gov record NCT04332510. Inclusion in this directory is not an endorsement.