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Growth and Metabolic Biomarkers of Healthy Term Infants Fed Formulas With Staged Protein Concentrations Over the First Year of Life

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ClinicalTrials.gov Identifier: NCT02646969
Recruitment Status : Recruiting
First Posted : January 6, 2016
Last Update Posted : September 19, 2018
Sponsor:
Information provided by (Responsible Party):
Nestlé

Brief Summary:
Growth and metabolic biomarkers of healthy term infants fed formulas with staged protein concentrations over the first year of life

Condition or disease Intervention/treatment Phase
Healthy Term Infants Dietary Supplement: Formula regimen 1 Dietary Supplement: Formula regimen 2 Not Applicable

Detailed Description:
The overall objective of this study is to assess growth and biomarkers of energy and protein metabolism in healthy term infants fed with two different study formula regimens from birth to 12 months of age and to follow up the infants to 4 years of age.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 690 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Other
Official Title: Growth and Metabolic Biomarkers of Healthy Term Infants Fed Formulas With Staged Protein Concentrations Over the First Year of Life
Actual Study Start Date : October 2015
Estimated Primary Completion Date : June 2022
Estimated Study Completion Date : June 2022

Arm Intervention/treatment
Active Comparator: Formula regimen 1

Product Control from enrollment to transition phase 1 (blinded administration), followed by open label administration for 2 months.

Product Test 2 from transition phase 2 to 1 year old (open label) Commercial follow up formula from 1 year old

Dietary Supplement: Formula regimen 1
Active Comparator: Formula regimen 2
Product Test 1 from enrollment to transition phase 1 (blinded administration) Product Control for 2 months(open label) Product Test 2 from transition phase 2 to 1 year old (open label) Commercial follow up formula from 1 year old
Dietary Supplement: Formula regimen 2
No Intervention: Reference group
Infants fed HM exclusively through at least 4 months of age. Once breastfeeding is over and if wished Infant will receive Product test 2 until 1 year old followed by the commercial follow-up formula



Primary Outcome Measures :
  1. Weight gain velocity (g/day) of formula regimen 1 versus WHO growth curve [ Time Frame: 0-6 months ]
  2. Weight gain velocity (g/day) of formula regimen 2 versus WHO growth curve [ Time Frame: 0-6 months ]

Secondary Outcome Measures :
  1. Weight gain velocity (g/day) of formula regimen 1 versus reference group [ Time Frame: 0-6 months ]
  2. Weight gain velocity (g/day) of formula regimen 2 versus reference group [ Time Frame: 0-6 months ]
  3. Measure of IGF-1, IGF-binding protein 2, IGF-binding protein 3, C-peptide, insulin, glucose, leptin, adiponectin and ghrelin in serum; measure of serum, fecal, and urinary metabolites related to protein and energy metabolism [ Time Frame: 0-4 years ]
  4. Fecal microbiota characterization [ Time Frame: 0-4 years ]


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Ages Eligible for Study:   up to 7 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Healthy infants will be enrolled in the study provided they meet the following inclusion criteria:

  1. Having obtained his/her parents' (or his/her legally accepted representative's [LAR's]) written informed consent and having evidence of personally signed and dated informed consent document indicating that the infant's parents/LAR have been informed of all pertinent aspects of the study.
  2. Age ≤ 7 days after birth (date of birth = Day 0)
  3. Full-term gestational birth (≥ 37 and ≤ 42 weeks)
  4. Born to mothers with pre-pregnancy body mass index (BMI) ≥ 18.5 and < 26 kg/m2
  5. Born to mothers who independently elected, before study enrollment, not to breastfeed (not applicable for infants in the HM-fed comparator group)
  6. Weight ≥ 2'500 g and ≤ 4'200 g
  7. Infant's parent(s)/LAR is of legal age of consent, has sufficient command of French language to complete the informed consent and other study documents, and is willing and able to fulfill the requirements of the study protocol
  8. Infant's parent(s)/LAR is able to be contacted directly by telephone throughout the study

Exclusion Criteria:

Infants who exhibit one or more of the following criteria are excluded from enrollment in the study:

  1. Born to mothers with hormonal or metabolic disease (e.g. Type-1, Type-2, or gestational diabetes diagnosed according to standardized criteria)
  2. Born to mothers who smoked > 10 cigarettes per day during pregnancy
  3. Born to mothers who used illicit drugs (e.g. marijuana, cocaine, amphetamines, or heroin) or alcohol (> 3 alcoholic beverages per week) during pregnancy
  4. Cognitive or physical developmental disorders (e.g. malabsorptive disorders such as short bowel syndrome; neurological and congenital disorders that may delay growth such as cerebral palsy, agenesis of the corpus callosum, spina bifida, Down Syndrome, Cri Du Chat; disorders that may lead to obesity such as Prader willi syndrome, Angelman syndrome; other renal, hepatic, pancreatic, or cardiovascular disorders)
  5. Received radiation therapy (eg. scannography or interventional radiology)
  6. Participation in any other clinical trial prior to enrollment
  7. Infants or infant's family who in the Investigator's judgment cannot be expected to comply with the protocol or study procedures

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): NCT02646969


Contacts
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Contact: Jean-Charles PICAUD, Pr +33 4 72 00 41 22

Locations
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France
CHU Pellegrin Recruiting
Bordeaux, France, 33000
Contact: Claude Billeaud, Prof         
Sponsors and Collaborators
Nestlé

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Responsible Party: Nestlé
ClinicalTrials.gov Identifier: NCT02646969     History of Changes
Other Study ID Numbers: 13.13.INF
First Posted: January 6, 2016    Key Record Dates
Last Update Posted: September 19, 2018
Last Verified: September 2018