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| Name | Class |
|---|---|
| Sodiaal International | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Breast milk | Placebo Comparator | group receiving breastfeeding |
|
| infant formula conventional BIO | Active Comparator | infant formula with conventional whey BIO |
|
| infant formula BIO TrueGreen | Active Comparator | infant formula with whey BIO TrueGreen |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Breastfeeding | Other | 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 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Evolution of growth of infants | Weight in kilograms | from 0 to 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Height evolution of infants | data in centimeters | from 0 to 6 months |
| BMI evolution of infants | data in kg/m² | from 0 to 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jean-Michel Lecerf, MD | Institut Pasteur de Lille - NutrInvest | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NutrInvest - Institut Pasteur de Lille | Lille | Nord | 59019 | France |
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| ID | Term |
|---|---|
| D007774 | Lactation |
| ID | Term |
|---|---|
| D055703 | Reproductive Physiological Phenomena |
| D012101 | Reproductive and Urinary Physiological Phenomena |
| D049590 | Postpartum Period |
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| Conventional BIO Infant formula | Other | 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 |
|
| TrueGreen BIO infant formula | Other | 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 |
|
| Head circumference evolution of infants | data in centimeters | from 0 to 6 months |
| Number of colic per day | Evaluation during 3 consecutives days every month. | from 0 to 6 months |
| Consistency of stool | 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 | 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 | Evaluation during 3 consecutive days every month. | from 0 to 6 months |
| Total sleep time per day | Time in hours. Evaluation during 3 consecutive days every month. | from 0 to 6 months |
| Plasma amino acid profile | 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 | 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 |