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

NCT04332510 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2020-04-02

No results posted yet for this study

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

  • To Compare the Metabolic Effects of Different Infant Milks

Interventions

OTHER

Intact formula

600 ml of infant formula with intact protein

OTHER

Partially hydrolyzed formula

600 ml of infant formula with partially hydrolyzed protein

OTHER

High protein formula

600 ml of infant formula with high protein level

OTHER

Human breast milk

600 ml of breast milk, safe for human consumption

Sponsors & Collaborators

  • Société des Produits Nestlé (SPN)

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
20 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-06-30
Primary Completion
2013-06-30
Completion
2013-06-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04332510 on ClinicalTrials.gov