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.
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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
-
Nord
-
Lille, Nord, Frankrig, 59019
- NutrInvest - Institut Pasteur de Lille
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Andet
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Placebo komparator: Breast milk
group receiving 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
|
|
Aktiv komparator: infant formula conventional BIO
infant formula with conventional whey BIO
|
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
|
|
Aktiv komparator: infant formula BIO TrueGreen
infant formula with whey BIO TrueGreen
|
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
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Evolution of growth of infants
Tidsramme: from 0 to 6 months
|
Weight in kilograms
|
from 0 to 6 months
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Height evolution of infants
Tidsramme: from 0 to 6 months
|
data in centimeters
|
from 0 to 6 months
|
|
BMI evolution of infants
Tidsramme: from 0 to 6 months
|
data in kg/m²
|
from 0 to 6 months
|
|
Head circumference evolution of infants
Tidsramme: from 0 to 6 months
|
data in centimeters
|
from 0 to 6 months
|
|
Number of colic per day
Tidsramme: from 0 to 6 months
|
Evaluation during 3 consecutives days every month.
|
from 0 to 6 months
|
|
Consistency of stool
Tidsramme: 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
Tidsramme: 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
The mean of score during 3 days is considered. |
from 0 to 6 months
|
|
Number of wake up per night
Tidsramme: from 0 to 6 months
|
Evaluation during 3 consecutive days every month.
|
from 0 to 6 months
|
|
Total sleep time per day
Tidsramme: from 0 to 6 months
|
Time in hours.
Evaluation during 3 consecutive days every month.
|
from 0 to 6 months
|
|
Plasma amino acid profile
Tidsramme: 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
Tidsramme: 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
|
Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- 2018-A00732-53
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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