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) |
Actual Enrollment : | 100 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Other |
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 |
Arm | Intervention/treatment |
---|---|
Placebo Comparator: Breast milk
group receiving breastfeeding
|
Other: 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
|
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.
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.
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)
Ages Eligible for Study: | up to 21 Days (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
France | |
NutrInvest - Institut Pasteur de Lille | |
Lille, Nord, France, 59019 |
Principal Investigator: | Jean-Michel Lecerf, MD | Institut Pasteur de Lille - NutrInvest |
Tracking Information | |||||
---|---|---|---|---|---|
First Submitted Date ICMJE | December 3, 2018 | ||||
First Posted Date ICMJE | May 3, 2019 | ||||
Last Update Posted Date | July 10, 2020 | ||||
Actual Study Start Date ICMJE | October 30, 2018 | ||||
Estimated Primary Completion Date | July 30, 2020 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
Evolution of growth of infants [ Time Frame: from 0 to 6 months ] Weight in kilograms
|
||||
Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures ICMJE |
|
||||
Original Secondary Outcome Measures ICMJE | Same as current | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | Effect of an Innovative BIO Formula Intake on Infant Growth and Tolerance From 0 to 6 Months | ||||
Official Title ICMJE | 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. | ||||
Brief Summary |
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. |
||||
Detailed Description | Not Provided | ||||
Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Not Applicable | ||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double (Participant, Investigator) Primary Purpose: Other |
||||
Condition ICMJE | Child Development | ||||
Intervention ICMJE |
|
||||
Study Arms ICMJE |
|
||||
Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||
Recruitment Information | |||||
Recruitment Status ICMJE | Active, not recruiting | ||||
Actual Enrollment ICMJE |
100 | ||||
Original Estimated Enrollment ICMJE | Same as current | ||||
Estimated Study Completion Date ICMJE | July 30, 2020 | ||||
Estimated Primary Completion Date | July 30, 2020 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
|
||||
Sex/Gender ICMJE |
|
||||
Ages ICMJE | up to 21 Days (Child) | ||||
Accepts Healthy Volunteers ICMJE | Yes | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | France | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT03936257 | ||||
Other Study ID Numbers ICMJE | 2018-A00732-53 | ||||
Has Data Monitoring Committee | Not Provided | ||||
U.S. FDA-regulated Product |
|
||||
IPD Sharing Statement ICMJE | Not Provided | ||||
Responsible Party | Jean-Michel Lecerf, Institut Pasteur de Lille | ||||
Study Sponsor ICMJE | Institut Pasteur de Lille | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE |
|
||||
PRS Account | Institut Pasteur de Lille | ||||
Verification Date | July 2020 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |