Effect of an Innovative BIO Formula Intake on Infant Growth and Tolerance From 0 to 6 Months (TRUEGREEN)
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|ClinicalTrials.gov Identifier: NCT03936257|
Recruitment Status : Recruiting
First Posted : May 3, 2019
Last Update Posted : May 3, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Child Development||Other: Breastfeeding Other: Conventional BIO Infant formula Other: TrueGreen BIO infant formula||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||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.|
|Actual Study Start Date :||October 30, 2018|
|Estimated Primary Completion Date :||July 30, 2020|
|Estimated Study Completion Date :||July 30, 2020|
Placebo Comparator: 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
Active Comparator: infant formula conventional BIO
infant formula with conventional whey BIO
Other: Conventional BIO Infant formula
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
Active Comparator: infant formula BIO TrueGreen
infant formula with whey BIO TrueGreen
Other: TrueGreen BIO infant formula
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
- Evolution of growth of infants [ Time Frame: from 0 to 6 months ]Weight in kilograms
- Height evolution of infants [ Time Frame: from 0 to 6 months ]data in centimeters
- BMI evolution of infants [ Time Frame: from 0 to 6 months ]data in kg/m²
- Head circumference evolution of infants [ Time Frame: from 0 to 6 months ]data in centimeters
- Number of colic per day [ Time Frame: from 0 to 6 months ]Evaluation during 3 consecutives days every month.
- Consistency of stool [ Time Frame: 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.
- Number of regurgitation [ Time Frame: 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
- ≥3-≤5 of small volume
- >5 episodes of >1 coffee spoon
- >5 episodes of half of the feedings in < half of the feedings
- Continuous regurgitations of small volumes >30 min after each feeding
- Regurgitation of half to complete volume of a feeding in at least half of the feedings
- Regurgitation of the 'complete feeding' after each feeding
The mean of score during 3 days is considered.
- Number of wake up per night [ Time Frame: from 0 to 6 months ]Evaluation during 3 consecutive days every month.
- Total sleep time per day [ Time Frame: from 0 to 6 months ]Time in hours. Evaluation during 3 consecutive days every month.
- Plasma amino acid profile [ Time Frame: 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
- Metabolomic analysis from plasma and urine samples [ Time Frame: 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)
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03936257
|Contact: Coralie Berthier, PhD||03 20 87 73 33 ext email@example.com|
|Contact: Jean-Michel Lecerf, MD||03 20 87 77 71 ext firstname.lastname@example.org|
|NutrInvest - Institut Pasteur de Lille||Recruiting|
|Lille, Nord, France, 59019|
|Contact: Jean-Michel Lecerf, MD +33 (0)3 20 87 77 71 email@example.com|
|Contact: Coralie Berthier, PhD +33 (0)3 20 87 73 33 firstname.lastname@example.org|
|Principal Investigator: Jean-Michel Lecerf, MD|
|Principal Investigator:||Jean-Michel Lecerf, MD||Institut Pasteur de Lille - NutrInvest|