Skip to main content
OpenTrials
Completed

NCT Number: NCT03936257

Effect of an Innovative BIO Formula Intake on Infant Growth and Tolerance 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Child Development

Age range

1 day–21 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

NutrInvest - Institut Pasteur de Lille

Lille, Nord, 59019, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

breastfeeding

Other

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 formula

Other

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 formula

Other

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 outcomes

  1. Evolution of growth of infants

    Time frame: from 0 to 6 months

    Weight in kilograms

Secondary outcomes

  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

    • ≥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.

  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)

Sponsors and collaborators

Lead sponsor

Institut Pasteur de Lille

Other

Collaborators

  • Sodiaal International

Registry information

Official study 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.

Acronym: TRUEGREEN

Important dates

Study start
2018
Primary completion
2020
Study completion
2021
First posted
May 3, 2019
Registry last updated
Apr 27, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.