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.
Přehled studie
Postavení
Podmínky
Typ studie
Zápis (Aktuální)
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
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Nord
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Lille, Nord, Francie, 59019
- NutrInvest - Institut Pasteur de Lille
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
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.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Jiný
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Dvojnásobek
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Komparátor placeba: Breast milk
group receiving breastfeeding
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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
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Aktivní komparátor: infant formula conventional BIO
infant formula with conventional whey BIO
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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
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Aktivní komparátor: infant formula BIO TrueGreen
infant formula with whey BIO TrueGreen
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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
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Evolution of growth of infants
Časové okno: from 0 to 6 months
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Weight in kilograms
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from 0 to 6 months
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Height evolution of infants
Časové okno: from 0 to 6 months
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data in centimeters
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from 0 to 6 months
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BMI evolution of infants
Časové okno: from 0 to 6 months
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data in kg/m²
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from 0 to 6 months
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Head circumference evolution of infants
Časové okno: from 0 to 6 months
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data in centimeters
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from 0 to 6 months
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Number of colic per day
Časové okno: from 0 to 6 months
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Evaluation during 3 consecutives days every month.
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from 0 to 6 months
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Consistency of stool
Časové okno: from 0 to 6 months
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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
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Number of regurgitation
Časové okno: from 0 to 6 months
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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
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Number of wake up per night
Časové okno: from 0 to 6 months
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Evaluation during 3 consecutive days every month.
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from 0 to 6 months
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Total sleep time per day
Časové okno: from 0 to 6 months
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Time in hours.
Evaluation during 3 consecutive days every month.
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from 0 to 6 months
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Plasma amino acid profile
Časové okno: between 3rd and 4th month
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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
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between 3rd and 4th month
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Metabolomic analysis from plasma and urine samples
Časové okno: between 3rd and 4th month
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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
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Spolupracovníci a vyšetřovatelé
Sponzor
Spolupracovníci
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další identifikační čísla studie
- 2018-A00732-53
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