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

April 20, 2022 updated by: Jean-Michel Lecerf, Institut Pasteur de Lille

Evaluation of an Innovative BIO Formula Based on a New Whey Extraction Process on the Growth and Tolerance of Infants From 0 to 6 Months.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Nord
      • Lille, Nord, France, 59019
        • NutrInvest - Institut Pasteur de Lille

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 day to 3 weeks (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 0 to 3 weeks
  • Child followed by a general practitioner or pediatrician
  • Informed consent form signed by the legal representatives of the subject
  • Commitment of legal representatives to follow the constraints generated by the study
  • Insured

Exclusion Criteria:

  • Infant born prematurely before 37 weeks of amenorrhea
  • Child allergic to cow's milk proteins
  • Pathological pregnancy (hypertension, infection, gestational diabetes, etc.);
  • Chronic or acute illness (metabolic or neuromuscular diseases, epilepsy, asthma, diabetes, digestive, renal, cardiac or haematological diseases);
  • Incapacity for the legal representative(s) to understand or adhere to the protocol
  • Subject involved in another clinical study or in an exclusion period from another study
  • Legal representatives deprived of liberty
  • Legal representatives in a position to judicial protection
  • Weight of the subject according to age and sex, not included between the 3rd and the 97th percentile of the WHO Child Growth Standards
  • Subject height according to age and sex, not between the 3rd and the 97th percentile of the WHO Child Growth Standards
  • BMI of the subject according to age and sex, not included between the 3rd and the 97th percentile of the WHO Child Growth Standards
  • Head circumference of the subject according to age and sex, not included between the 3rd and the 97th percentile of the WHO (World Health Organization) Child Growth Standards
  • The investigator considers that the state of health or the concomitant treatments are not compatible with the good progress of the clinical study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Breast milk
group receiving breastfeeding
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
Active Comparator: infant formula conventional BIO
infant formula with conventional whey BIO
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
Active Comparator: infant formula BIO TrueGreen
infant formula with whey BIO TrueGreen
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evolution of growth of infants
Time Frame: from 0 to 6 months
Weight in kilograms
from 0 to 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Height evolution of infants
Time Frame: from 0 to 6 months
data in centimeters
from 0 to 6 months
BMI evolution of infants
Time Frame: from 0 to 6 months
data in kg/m²
from 0 to 6 months
Head circumference evolution of infants
Time Frame: from 0 to 6 months
data in centimeters
from 0 to 6 months
Number of colic per day
Time Frame: from 0 to 6 months
Evaluation during 3 consecutives days every month.
from 0 to 6 months
Consistency of stool
Time Frame: from 0 to 6 months

Evaluation during 3 consecutive days every month via Bristol scale.

According to the bristol scale, seven types of stool are considered:

Type 1: Separate hard lumps, like nuts (hard to pass) Type 2: Sausage-shaped, but lumpy Type 3: Like a sausage but with cracks on its surface Type 4: Like a sausage or snake, smooth and soft Type 5: Soft blobs with clear cut edges (easy to pass) Type 6: Fluffy pieces with ragged edges, a mushy stool Type 7: Watery, no solid pieces, entirely liquid

The mean of stool type during 3 days is considered.
from 0 to 6 months
Number of regurgitation
Time Frame: from 0 to 6 months

Evaluation during 3 consecutive days every month via Vandenplas scale.

According to the Vandenplas scale, seven score are considered:

0 0-2 episodes/day

  1. ≥3-≤5 of small volume
  2. >5 episodes of >1 coffee spoon
  3. >5 episodes of half of the feedings in < half of the feedings
  4. Continuous regurgitations of small volumes >30 min after each feeding
  5. Regurgitation of half to complete volume of a feeding in at least half of the feedings
  6. Regurgitation of the 'complete feeding' after each feeding

The mean of score during 3 days is considered.
from 0 to 6 months
Number of wake up per night
Time Frame: from 0 to 6 months
Evaluation during 3 consecutive days every month.
from 0 to 6 months
Total sleep time per day
Time Frame: from 0 to 6 months
Time in hours. Evaluation during 3 consecutive days every month.
from 0 to 6 months
Plasma amino acid profile
Time Frame: between 3rd and 4th month
Methods : Liquid Chromatography and Tandem Mass Spectrometry (LC / MS / MS) List of amino acids : Taurine, Aspartic acid, Threonine, Serine, Asparagine, Glutamine acid, Glutamine, Glycine, Alanine, Citrulline, Valine, Cystine, Methionine, Isoleucine, Leucine, Tyrosine, Phenylalanine, Beta aminoisobutyric acid, Ornithine, 1-Methyl-Histidine, Histidine, Lysine, 3-methyl-Histidine, Arginine, Hydroxyproline, Proline
between 3rd and 4th month
Metabolomic analysis from plasma and urine samples
Time Frame: between 3rd and 4th month

Non-targeted analysis : evaluation of all small molecules in biological system, such as amino acids, sugars, alcohols, sugar phosphates, amines, fatty acids, polar lipids, hormones and vitamins, as well as specialized metabolites, such as phenolic compounds, flavonoids, monoterpenes, sesquiterpenes, polyketides, alkaloids, including xenobiotics.

Methods : Liquid Chromatography and Mass Spectrometry (LC / MS)
between 3rd and 4th month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut Pasteur de Lille

Collaborators

Sodiaal International

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 30, 2018

Primary Completion (Actual)

July 30, 2020

Study Completion (Actual)

December 30, 2021

Study Registration Dates

First Submitted

December 3, 2018

First Submitted That Met QC Criteria

April 30, 2019

First Posted (Actual)

May 3, 2019

Study Record Updates

Last Update Posted (Actual)

April 27, 2022

Last Update Submitted That Met QC Criteria

April 20, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • 2018-A00732-53

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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