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

Pasteur Institute of Lille (IPL)

Status: Completed

Conditions: Child Development

Treatments: Other: Conventional BIO Infant formula; Other: TrueGreen BIO infant formula; Other: Breastfeeding

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03936257

2018-A00732-53

Details and patient eligibility

About

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.

Enrollment: 100 patients

Sex: All

Ages: 1 to 21 days old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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100 participants in 3 patient groups, including a placebo group

Breast milk

Placebo Comparator group

Description:

group receiving breastfeeding

Treatment:

Other: Breastfeeding

infant formula conventional BIO

Active Comparator group

Description:

infant formula with conventional whey BIO

Treatment:

Other: Conventional BIO Infant formula

infant formula BIO TrueGreen

Active Comparator group

Description:

infant formula with whey BIO TrueGreen

Treatment:

Other: TrueGreen BIO infant formula