Child DevelopmentTRUEGREENNCT03936257
Effect of an Innovative BIO Formula Intake on Infant Growth and Tolerance From 0 to 6 Months
A study testing Breastfeeding, Conventional BIO Infant formula and TrueGreen BIO infant formula in people with Child Development, run by Institut Pasteur de Lille at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 day to 21 daysHealthy volunteers can take part
- Conditions the study is for
- Child Development
- What is being tested?
- Breastfeeding, Conventional BIO Infant formula and TrueGreen BIO infant formula
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 30 Oct 2018to 30 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 21 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
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.
- Conditions
- Child Development
- Being tested
- Breastfeeding, Conventional BIO Infant formula, TrueGreen BIO infant formula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BreastfeedingOther
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
Conventional BIO Infant formulaOther
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 formulaOther
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 group | Role | What they receive |
|---|---|---|
| Breast milk | Placebo comparator | group receiving breastfeeding Receives: Other: Breastfeeding |
| infant formula conventional BIO | Active comparator | infant formula with conventional whey BIO Receives: Other: Conventional BIO Infant formula |
| infant formula BIO TrueGreen | Active comparator | infant formula with whey BIO TrueGreen Receives: Other: TrueGreen BIO infant formula |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evolution of growth of infants
Weight in kilograms
Measured: from 0 to 6 months
Secondary outcomes (10)
Height evolution of infants
data in centimeters
Measured: from 0 to 6 months
BMI evolution of infants
data in kg/m²
Measured: from 0 to 6 months
Head circumference evolution of infants
data in centimeters
Measured: from 0 to 6 months
Number of colic per day
Evaluation during 3 consecutives days every month.
Measured: 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.
Measured: 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
- ≥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.
Measured: from 0 to 6 months
Number of wake up per night
Evaluation during 3 consecutive days every month.
Measured: from 0 to 6 months
Total sleep time per day
Time in hours. Evaluation during 3 consecutive days every month.
Measured: 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
Measured: 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)
Measured: between 3rd and 4th month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2019
- Study start30 Oct 2018
- Primary completion30 Jul 2020
- Study completion30 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Child DevelopmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Pasteur de Lille
- Sponsor type
- University, hospital or other
- Collaborators
- Sodiaal International
- Responsible party
- Principal investigator, Jean-Michel Lecerf, Institut Pasteur de Lille
- Investigators
- Jean-Michel Lecerf, MD, Principal investigator, Institut Pasteur de Lille - NutrInvest
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03936257
- Sponsor's protocol ID
- 2018-A00732-53
- Acronym
- TRUEGREEN
- Status last verified
- Apr 2022
- First submitted
- 3 Dec 2018
- Last updated
- 27 Apr 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Pinon A, Trentesaux C, Chaffaut C, Lemaire M, Parere X, Lecerf JM, Schnebelen-Berthier C. Infant growth and tolerance with a formula based on novel native demineralized whey: A randomized double-blind pilot study. J Pediatr Gastroenterol Nutr. 2024 Oct;79(4):905-914. doi: 10.1002/jpn3.12305. Epub 2024 Jul 11.
PubMed 38988234
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT03936257
- Acronym / sponsor ID
- TRUEGREEN / 2018-A00732-53
- Conditions
- Child Development
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Institut Pasteur de LilleUniversity, hospital or other
- Collaborators
- Sodiaal International
- Study start
- 30 Oct 2018 (actual)
- Primary completion
- 30 Jul 2020 (actual)
- Study completion
- 30 Dec 2021 (actual)
- First posted
- 3 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Breast milk | Placebo comparator | Other: Breastfeedinggroup receiving breastfeeding |
| infant formula conventional BIO | Active comparator | Other: Conventional BIO Infant formulainfant formula with conventional whey BIO |
| infant formula BIO TrueGreen | Active comparator | Other: TrueGreen BIO infant formulainfant formula with whey BIO TrueGreen |
Who may qualify
- Ages
- 1 day to 21 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BreastfeedingInfants 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 | Breast milk |
| Conventional BIO Infant formulaInfant 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 | infant formula conventional BIO |
| TrueGreen BIO infant formulaInfant 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 | Other | infant formula BIO TrueGreen |
Primary outcome
Evolution of growth of infants
Time frame: from 0 to 6 months
Weight in kilograms
10 secondary outcomes
Height evolution of infants
Time frame: from 0 to 6 months
BMI evolution of infants
Time frame: from 0 to 6 months
Head circumference evolution of infants
Time frame: from 0 to 6 months
Number of colic per day
Time frame: from 0 to 6 months
Consistency of stool
Time frame: from 0 to 6 months
Number of regurgitation
Time frame: from 0 to 6 months
Number of wake up per night
Time frame: from 0 to 6 months
Total sleep time per day
Time frame: from 0 to 6 months
Plasma amino acid profile
Time frame: between 3rd and 4th month
Metabolomic analysis from plasma and urine samples
Time frame: between 3rd and 4th month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2022.
- Derived from this study: PubMed 38988234Pinon A, Trentesaux C, Chaffaut C, Lemaire M, Parere X, Lecerf JM, Schnebelen-Berthier C. Infant growth and tolerance with a formula based on novel native demineralized whey: A randomized double-blind pilot study. J Pediatr Gastroenterol Nutr. 2024 Oct;79(4):905-914. doi: 10.1002/jpn3.12305. Epub 2024 Jul 11.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean-Michel Lecerf, MD principal investigator
Institut Pasteur de Lille - NutrInvest
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Breastfeeding, Conventional BIO Infant formula and TrueGreen BIO infant formula in people with Child Development, run by Institut Pasteur de Lille at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evolution of growth of infants (time frame: from 0 to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03936257, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2022.