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KPV

Lys-Pro-Val, α-MSH (11-13)

Quick Stats
Studies 104
Trials 57
Completed NA INTERVENTIONAL NCT03936257

Effect of an Innovative BIO Formula Intake on Infant Growth and Tolerance From 0 to 6 Months

View on ClinicalTrials.gov Updated Dec 15, 2025

Brief Summary

From birth to 5 months, milk is the essential and unique food of the newborn. The French National Nutrition Program (PNNS) recommends exclusive breastfeeding "up to 6 months and at least 4 months for a healthy benefit". However, only 36% of infants 0-6 months of age are exclusively breastfed worldwide. Some mothers choose to give infant formula to their baby in the first few months of life. This decision may be a personal choice or be imposed by pathophysiological situations. The nutritional requirements of the infant are specific, which implies adequate nutrition. Infant formulas and follow-up formulas are therefore complex products, specially developed for a group of vulnerable consumers. In fact, the compositional and information requirements for infant formula are highly regulated. This study, defined as a pilot study, proposes to evaluate the innovative "TrueGreen" BIO infant formula based on a new whey extraction method on the growth and tolerance of infants from 0 to 6 months compared to the conventional BIO infant formula. As no growth and tolerance data are currently available for this new TrueGreen BIO formula, this study aims to determine them.

Interventions

Name: Breastfeeding
Type: OTHER
Description: Infants were breastfed during 3 months minimum. Data on growth and tolerance were collected. 10 out of 40 infants take a blood test to metabolome analysis
Name: Conventional BIO Infant formula
Type: OTHER
Description: Infant were fed during 6 months with a conventional BIO infant formula. Data on growth and tolerance were collected. 10 out of 40 infants take a blood test to metabolome analysis
Name: TrueGreen BIO infant formula
Type: OTHER
Description: Infant were fed during 6 months with the TrueGreen BIO infant formula. Data on growth and tolerance were collected. 10 out of 40 infants take a blood test to metabolome analysis

Primary Outcomes

Measure: Evolution of growth of infants
TimeFrame: from 0 to 6 months
Description: Weight in kilograms

Trial Information

NCT ID

NCT03936257

Status

Completed

Study Type

INTERVENTIONAL

Phases

NA

Sponsor

Institut Pasteur de Lille

Last Updated

December 15, 2025