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.
Przegląd badań
Status
Warunki
Interwencja / Leczenie
Typ studiów
Zapisy (Rzeczywisty)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Lokalizacje studiów
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Nord
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Lille, Nord, Francja, 59019
- NutrInvest - Institut Pasteur de Lille
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
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.
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Inny
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Podwójnie
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
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Komparator placebo: 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
|
|
Aktywny komparator: 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
|
|
Aktywny komparator: 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 mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Evolution of growth of infants
Ramy czasowe: from 0 to 6 months
|
Weight in kilograms
|
from 0 to 6 months
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Height evolution of infants
Ramy czasowe: from 0 to 6 months
|
data in centimeters
|
from 0 to 6 months
|
|
BMI evolution of infants
Ramy czasowe: from 0 to 6 months
|
data in kg/m²
|
from 0 to 6 months
|
|
Head circumference evolution of infants
Ramy czasowe: from 0 to 6 months
|
data in centimeters
|
from 0 to 6 months
|
|
Number of colic per day
Ramy czasowe: from 0 to 6 months
|
Evaluation during 3 consecutives days every month.
|
from 0 to 6 months
|
|
Consistency of stool
Ramy czasowe: 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
|
|
Number of regurgitation
Ramy czasowe: 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
|
|
Number of wake up per night
Ramy czasowe: 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
Ramy czasowe: from 0 to 6 months
|
Time in hours.
Evaluation during 3 consecutive days every month.
|
from 0 to 6 months
|
|
Plasma amino acid profile
Ramy czasowe: 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
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between 3rd and 4th month
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Metabolomic analysis from plasma and urine samples
Ramy czasowe: 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
|
Współpracownicy i badacze
Sponsor
Współpracownicy
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Zakończenie podstawowe (Rzeczywisty)
Ukończenie studiów (Rzeczywisty)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Inne numery identyfikacyjne badania
- 2018-A00732-53
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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