Effect of an Innovative BIO Formula Intake on Infant Growth and Tolerance From 0 to 6 Months
TRUEGREEN
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.
1 other identifier
interventional
100
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Oct 2018
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 30, 2018
CompletedFirst Submitted
Initial submission to the registry
December 3, 2018
CompletedFirst Posted
Study publicly available on registry
May 3, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 30, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2021
CompletedApril 27, 2022
April 1, 2022
1.8 years
December 3, 2018
April 20, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Evolution of growth of infants
Weight in kilograms
from 0 to 6 months
Secondary Outcomes (10)
Height evolution of infants
from 0 to 6 months
BMI evolution of infants
from 0 to 6 months
Head circumference evolution of infants
from 0 to 6 months
Number of colic per day
from 0 to 6 months
Consistency of stool
from 0 to 6 months
- +5 more secondary outcomes
Study Arms (3)
Breast milk
PLACEBO COMPARATORgroup receiving breastfeeding
infant formula conventional BIO
ACTIVE COMPARATORinfant formula with conventional whey BIO
infant formula BIO TrueGreen
ACTIVE COMPARATORinfant formula with whey BIO TrueGreen
Interventions
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
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
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
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Institut Pasteur de Lillelead
- Sodiaal Internationalcollaborator
Study Sites (1)
NutrInvest - Institut Pasteur de Lille
Lille, Nord, 59019, France
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jean-Michel Lecerf, MD
Institut Pasteur de Lille - NutrInvest
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
December 3, 2018
First Posted
May 3, 2019
Study Start
October 30, 2018
Primary Completion
July 30, 2020
Study Completion
December 30, 2021
Last Updated
April 27, 2022
Record last verified: 2022-04