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

NCT03936257 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2022-04-27

No results posted yet for this study

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.

Conditions

  • Child Development

Interventions

OTHER

Breastfeeding

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

OTHER

Conventional BIO Infant formula

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

OTHER

TrueGreen BIO infant formula

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

Sponsors & Collaborators

  • Sodiaal International

    collaborator INDUSTRY

  • Institut Pasteur de Lille

    lead OTHER

Principal Investigators

  • Jean-Michel Lecerf, MD · Institut Pasteur de Lille - NutrInvest

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
1 Day
Max Age
21 Days
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-10-30
Primary Completion
2020-07-30
Completion
2021-12-30

Countries

  • France

Study Locations

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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 NCT03936257 on ClinicalTrials.gov