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出境医 / 临床实验 / Effect of an Innovative BIO Formula Intake on Infant Growth and Tolerance From 0 to 6 Months (TRUEGREEN)

Effect of an Innovative BIO Formula Intake on Infant Growth and Tolerance From 0 to 6 Months (TRUEGREEN)

Study Description
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.


Condition or disease Intervention/treatment Phase
Child Development Other: Breastfeeding Other: Conventional BIO Infant formula Other: TrueGreen BIO infant formula Not Applicable

Study Design
Layout table for study information
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
Arms and Interventions
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

Outcome Measures
Primary Outcome Measures :
  1. Evolution of growth of infants [ Time Frame: from 0 to 6 months ]
    Weight in kilograms


Secondary Outcome Measures :
  1. Height evolution of infants [ Time Frame: from 0 to 6 months ]
    data in centimeters

  2. BMI evolution of infants [ Time Frame: from 0 to 6 months ]
    data in kg/m²

  3. Head circumference evolution of infants [ Time Frame: from 0 to 6 months ]
    data in centimeters

  4. Number of colic per day [ Time Frame: from 0 to 6 months ]
    Evaluation during 3 consecutives days every month.

  5. 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.


  6. 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

    1. ≥3-≤5 of small volume
    2. >5 episodes of >1 coffee spoon
    3. >5 episodes of half of the feedings in < half of the feedings
    4. Continuous regurgitations of small volumes >30 min after each feeding
    5. Regurgitation of half to complete volume of a feeding in at least half of the feedings
    6. Regurgitation of the 'complete feeding' after each feeding

    The mean of score during 3 days is considered.


  7. Number of wake up per night [ Time Frame: from 0 to 6 months ]
    Evaluation during 3 consecutive days every month.

  8. Total sleep time per day [ Time Frame: from 0 to 6 months ]
    Time in hours. Evaluation during 3 consecutive days every month.

  9. 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

  10. 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)



Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   up to 21 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
Contacts and Locations

Locations
Layout table for location information
France
NutrInvest - Institut Pasteur de Lille
Lille, Nord, France, 59019
Sponsors and Collaborators
Institut Pasteur de Lille
Investigators
Layout table for investigator information
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
 (submitted: April 30, 2019)
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
 (submitted: April 30, 2019)
  • 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
    1. ≥3-≤5 of small volume
    2. >5 episodes of >1 coffee spoon
    3. >5 episodes of half of the feedings in < half of the feedings
    4. Continuous regurgitations of small volumes >30 min after each feeding
    5. Regurgitation of half to complete volume of a feeding in at least half of the feedings
    6. 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)
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
  • 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
  • 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
  • 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
Study Arms  ICMJE
  • Placebo Comparator: Breast milk
    group receiving breastfeeding
    Intervention: Other: Breastfeeding
  • Active Comparator: infant formula conventional BIO
    infant formula with conventional whey BIO
    Intervention: Other: Conventional BIO Infant formula
  • Active Comparator: infant formula BIO TrueGreen
    infant formula with whey BIO TrueGreen
    Intervention: Other: TrueGreen BIO infant formula
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
 (submitted: April 30, 2019)
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:

  • 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
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
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
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
Principal Investigator: Jean-Michel Lecerf, MD Institut Pasteur de Lille - NutrInvest
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