Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03936257
Recruitment Status : Recruiting
First Posted : May 3, 2019
Last Update Posted : May 3, 2019
Sponsor:
Information provided by (Responsible Party):
Jean-Michel Lecerf, Institut Pasteur de Lille

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

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated 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

Resource links provided by the National Library of Medicine


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




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)




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03936257


Contacts
Layout table for location contacts
Contact: Coralie Berthier, PhD 03 20 87 73 33 ext 0033 coralie.berthier@pasteur-lille.fr
Contact: Jean-Michel Lecerf, MD 03 20 87 77 71 ext 0033 jean-michel.lecerf@pasteur-lille.fr

Locations
Layout table for location information
France
NutrInvest - Institut Pasteur de Lille Recruiting
Lille, Nord, France, 59019
Contact: Jean-Michel Lecerf, MD    +33 (0)3 20 87 77 71    jean-michel.lecerf@pasteur-lille.fr   
Contact: Coralie Berthier, PhD    +33 (0)3 20 87 73 33    coralie.berthier@pasteur-lille.fr   
Principal Investigator: Jean-Michel Lecerf, MD         
Sponsors and Collaborators
Institut Pasteur de Lille
Investigators
Layout table for investigator information
Principal Investigator: Jean-Michel Lecerf, MD Institut Pasteur de Lille - NutrInvest
Layout table for additonal information
Responsible Party: Jean-Michel Lecerf, Professor, Institut Pasteur de Lille
ClinicalTrials.gov Identifier: NCT03936257    
Other Study ID Numbers: 2018-A00732-53
First Posted: May 3, 2019    Key Record Dates
Last Update Posted: May 3, 2019
Last Verified: April 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No