GrowthPhase 2TENUTONCT03062761
A Clinical Study to Investigate the Effects of an Infant Formula Containing Partially Hydrolysed Proteins on Growth, Safety and Tolerance in Healthy Term Infants
A Phase 2 study testing Infant Formula with prebiotics and Standard Infant Formula in people with Growth, run by Nutricia Research at 15 sites in 6 countries.
Trial summary
It is universally accepted that the best nutrition for a new-born infant is breast milk. Breast milk provides a complete set of nutrients to support growth and development of children in early life, including components that have a beneficial effect on gut health and the body's ability to defend itself against… Read more about this study
- Who is it for?
- Ages Up to 14 daysHealthy volunteers can take part
- Conditions the study is for
- Growth
- What is being tested?
- Infant Formula with prebiotics and Standard Infant Formula
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 380 participants
- Where
- 15 sitesin 6 countries
- Study dates
- 27 Apr 2017to 12 Nov 2018
- Phase
- Phase 2
- 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 Up to 14 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Healthy term infants (gestational age ≥ 37 weeks + 0 days and ≤ 41 weeks + 6 days);
- Infants' age at enrolment ≤ 14 days;
- Birth weight within normal range for gestational age and sex (10th to 90th percentile according to the WHO Child Growth Standards - or local growth standards if available);
- Head circumference at inclusion within normal range for age and sex (within 2 SD curves according to WHO Child Growth Standards - or local growth standards if available);
- Infant formula arms: infants who are exclusively formula fed by time of randomisation with a maximum infants' age of 14 days (infants of mothers who choose not to breastfeed or mothers who cease breastfeeding for any reason before the infant is 14 days of age); OR Breastfeeding reference arm: infants who are exclusively breastfed and whose mothers are intending to exclusively breastfeed their infant at least until the infant is 17 weeks of age; 6 Written informed consent from parent(s) and/or legal guardian(s) aged ≥ 18 years.
Who cannot join
- Infants of pregnant women/mothers:
- who are currently participating or will participate in any other (clinical) study involving investigational or marketed products during pregnancy and/or lactation;
- known to have a significant medical condition (including during pregnancy) that might interfere with the study or known to affect intra-uterine growth (e.g. placenta previa, pre-eclampsia, eclampsia, gestational diabetes requiring insulin or oral medication), as per investigator's clinical judgement;
- Infants of parents:
- who are incapable to comply with study protocol or Investigator's uncertainty about the willingness or ability of the parents to comply with the protocol requirements;
- Infants:
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- who have to be fed with a special diet other than standard (non-hydrolysed) cow's milk based infant formula
- known to have current or previous illnesses/conditions which could interfere with the study or its outcome parameters, such as gastrointestinal malformations, congenital metabolic disorders, immune deficiency or major surgery, as per investigator's clinical judgement;
- with any history of, or current participation in any other study involving investigational or marketed products.
Trial locations and contacts
15 sites in 6 countries.
15 sites in 6 countries
Poland5 sites
Poliklinika Ginekologiczno-Poloznicza Sp. z o.o. Sp.k
Bialystok
Specjalistyczna Poradnia Medyczna Przylądek Zdrowia
Krakow
POLMED / Instytut Mikroekologii
Poznan
Korczowski Bartosz, Gabinet Lekarski
Rzeszów
NZLA Michalkowice Jarosz i Partnerzy Spolka Lekarska
Siemianowice Śląskie
Spain4 sites
Hospital Quirónsalud Barcelona
Barcelona
Hospital General Universitario de Elche
Elche
Hospital Universitari Sant Joan de Reus (IISPV)
Reus
Hospital Universitari de Tarragona Joan XXIII
Tarragona
France2 sites
Groupement des Hopitaux de l'institut Catholique de Lille
Lille
Hospices Civils de Lyon
Lyon
Germany2 sites
Vivantes Klinik für Geburtsmedizin, Klinikum Neukölln
Berlin
Paediatric Practice
Bramsche
About this study
Official title: A Randomized, Controlled, Double Blind, Parallel Group, Multi-country Study to Investigate the Effects of an Infant Formula Containing Partially Hydrolysed Proteins on Growth, Safety and Tolerance in Healthy Term Infants
It is universally accepted that the best nutrition for a new-born infant is breast milk. Breast milk provides a complete set of nutrients to support growth and development of children in early life, including components that have a beneficial effect on gut health and the body's ability to defend itself against infectious organisms and other invaders (immune system).However, it may occur that a mother is unable to breastfeed her child, or chooses not to breastfeed. In such cases, an infant formula inspired by breast milk is the best alternative. Research is done to optimize milk formula for infants. One of these formulas contains 'partially hydrolyzed' proteins instead of intact proteins, meaning the proteins in this formula are broken down into smaller pieces. These smaller pieces of protein make the milk more suitable for consumption by infants at risk of developing cow's milk allergy. These types of partially hydrolyzed protein formulas have been on the market for several years, in particular for children with a family risk of allergy. So far, no safety related issues have been reported. It is also known that weight gain of infants receiving partially hydrolyzed proteins in general is appropriate according to the World Health Organisation growth standards.
The main purpose of the TENUTO study is to demonstrate that infants who receive a specific partially hydrolyzed protein infant formula for the first 4 months of life have a similar weight gain compared to infants receiving standard infant formula with intact proteins. A group of infants who receive breast milk only is also included for comparison.
- Conditions
- Growth
- Being tested
- Infant Formula with prebiotics, Standard Infant Formula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Infant Formula with prebioticsOther
Intervention group: Partially hydrolysed whey protein based infant formula containing prebiotics.
Standard Infant FormulaOther
Control group: Intact cow's milk protein based infant formula containing prebiotics
| Study group | Role | What they receive |
|---|---|---|
| Active product: partially hydrolysed proteins | Experimental | Partially hydrolysed whey protein based infant formula containing prebiotics. Receives: Other: Infant Formula with prebiotics |
| Control product: standard formula (intact protein) | Active comparator | Intact cow's milk protein based infant formula containing prebiotics. Receives: Other: Standard Infant Formula |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight gain
Weight gain in grams per day from baseline until 17 weeks of age
Measured: 17 weeks
Secondary outcomes (17)
Length
Gain in Recumbent length (mm/day)
Measured: 17 weeks
Head circumference
Gain in Head circumference (mm/day)
Measured: 17 weeks
Mid-upper arm circumference
Gain in Mid-upper arm circumference (mm/day)
Measured: 17 weeks
Anthropometric measures
Z scores of anthropometric parameters
Measured: 17 weeks
Albumin level
Albumin in blood (g/L)
Measured: 17 weeks
Calcium level
Calcium in blood (mmol/l)
Measured: 17 weeks
Phosphorus level
Phosphorus in blood (mmol/l)
Measured: 17 weeks
Iron level
Iron (µmol/l) in blood
Measured: 17 weeks
Magnesium level
Magnesium (mmol/l) in blood
Measured: 17 weeks
Nitrogen level
Blood urea nitrogen (mmol/l)
Measured: 17 weeks
Number of subjects with adverse events
Adverse events (by "System/Organ Class" and "Preferred term" according the MedDRA ) will be reported as number of subjects with at least one adverse event
Measured: 17 weeks
Number of adverse events
Number of adverse events (by "System/Organ Class" and "Preferred term" according the MedDRA)
Measured: 17 weeks
Concomitant medications
All concomitant medications (according to WHO-DDE) will be summarised in individual data listing
Measured: 17 weeks
Regurgitation
Regurgitation nr of occurrences per week
Measured: 4, 8, 13 and 17 weeks
Vomiting
Vomiting nr of occurrences per week
Measured: 4, 8, 13 and 17 weeks
Diarrhoea
Number of infants with diarrhoea (definition adapted from WHO definition based on number of watery stools per day)
Measured: 4, 8, 13 and 17 weeks
Constipation
Number of infants with constipation (definition adapted from Rome II criteria based on number of defecations and consistency per week)
Measured: 4, 8, 13 and 17 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2017
- Study start27 Apr 2017
- Primary completion26 Oct 2018
- Study completion12 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GrowthStudies of the same condition, open and under way.
- More trials run by Nutricia ResearchThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 380 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nutricia Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03062761
- Sponsor's protocol ID
- EBB15BL89832
- Acronym
- TENUTO
- Status last verified
- Jan 2019
- First submitted
- 3 Feb 2017
- Last updated
- 14 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Controlled, Double Blind, Parallel Group, Multi-country Study to Investigate the Effects of an Infant Formula Containing Partially Hydrolysed Proteins on Growth, Safety and Tolerance in Healthy Term Infants
- ClinicalTrials.gov ID
- NCT03062761
- Acronym / sponsor ID
- TENUTO / EBB15BL89832
- Conditions
- Growth
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 380 participants (actual)
- Lead sponsor
- Nutricia ResearchIndustry (pharma, biotech, devices)
- Study start
- 27 Apr 2017 (actual)
- Primary completion
- 26 Oct 2018 (actual)
- Study completion
- 12 Nov 2018 (actual)
- First posted
- 23 Feb 2017 (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.
It is universally accepted that the best nutrition for a new-born infant is breast milk. Breast milk provides a complete set of nutrients to support growth and development of children in early life, including components that have a beneficial effect on gut health and the body's ability to defend itself against infectious organisms and other invaders (immune system).However, it may occur that a mother is unable to breastfeed her child, or chooses not to breastfeed. In such cases, an infant formula inspired by breast milk is the best alternative. Research is done to optimize milk formula for infants. One of these formulas contains 'partially hydrolyzed' proteins instead of intact proteins, meaning the proteins in this formula are broken down into smaller pieces. These smaller pieces of protein make the milk more suitable for consumption by infants at risk of developing cow's milk allergy. These types of partially hydrolyzed protein formulas have been on the market for several years, in particular for children with a family risk of allergy. So far, no safety related issues have been reported. It is also known that weight gain of infants receiving partially hydrolyzed proteins in general is appropriate according to the World Health Organisation growth standards.
The main purpose of the TENUTO study is to demonstrate that infants who receive a specific partially hydrolyzed protein infant formula for the first 4 months of life have a similar weight gain compared to infants receiving standard infant formula with intact proteins. A group of infants who receive breast milk only is also included for comparison.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active product: partially hydrolysed proteins | Experimental | Other: Infant Formula with prebioticsPartially hydrolysed whey protein based infant formula containing prebiotics. |
| Control product: standard formula (intact protein) | Active comparator | Other: Standard Infant FormulaIntact cow's milk protein based infant formula containing prebiotics. |
Who may qualify
- Ages
- Up to 14 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Healthy term infants (gestational age ≥ 37 weeks + 0 days and ≤ 41 weeks + 6 days);
- Infants' age at enrolment ≤ 14 days;
- Birth weight within normal range for gestational age and sex (10th to 90th percentile according to the WHO Child Growth Standards - or local growth standards if available);
- Head circumference at inclusion within normal range for age and sex (within 2 SD curves according to WHO Child Growth Standards - or local growth standards if available);
- Infant formula arms: infants who are exclusively formula fed by time of randomisation with a maximum infants' age of 14 days (infants of mothers who choose not to breastfeed or mothers who cease breastfeeding for any reason before the infant is 14 days of age); OR Breastfeeding reference arm: infants who are exclusively breastfed and whose mothers are intending to exclusively breastfeed their infant at least until the infant is 17 weeks of age; 6 Written informed consent from parent(s) and/or legal guardian(s) aged ≥ 18 years.
Key exclusion criteria (9 listed)
- who are currently participating or will participate in any other (clinical) study involving investigational or marketed products during pregnancy and/or lactation;
- known to have a significant medical condition (including during pregnancy) that might interfere with the study or known to affect intra-uterine growth (e.g. placenta previa, pre-eclampsia, eclampsia, gestational diabetes requiring insulin or oral medication), as per investigator's clinical judgement;
- who are incapable to comply with study protocol or Investigator's uncertainty about the willingness or ability of the parents to comply with the protocol requirements;
- who have to be fed with a special diet other than standard (non-hydrolysed) cow's milk based infant formula
- known to have current or previous illnesses/conditions which could interfere with the study or its outcome parameters, such as gastrointestinal malformations, congenital metabolic disorders, immune deficiency or major surgery, as per investigator's clinical judgement;
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 |
|---|---|---|
| Infant Formula with prebioticsIntervention group: Partially hydrolysed whey protein based infant formula containing prebiotics. | Other | Active product: partially hydrolysed proteins |
| Standard Infant FormulaControl group: Intact cow's milk protein based infant formula containing prebiotics | Other | Control product: standard formula (intact protein) |
Primary outcome
Weight gain
Time frame: 17 weeks
Weight gain in grams per day from baseline until 17 weeks of age
17 secondary outcomes
Length
Time frame: 17 weeks
Head circumference
Time frame: 17 weeks
Mid-upper arm circumference
Time frame: 17 weeks
Anthropometric measures
Time frame: 17 weeks
Albumin level
Time frame: 17 weeks
Calcium level
Time frame: 17 weeks
Phosphorus level
Time frame: 17 weeks
Iron level
Time frame: 17 weeks
Magnesium level
Time frame: 17 weeks
Nitrogen level
Time frame: 17 weeks
Number of subjects with adverse events
Time frame: 17 weeks
Number of adverse events
Time frame: 17 weeks
Concomitant medications
Time frame: 17 weeks
Regurgitation
Time frame: 4, 8, 13 and 17 weeks
Vomiting
Time frame: 4, 8, 13 and 17 weeks
Diarrhoea
Time frame: 4, 8, 13 and 17 weeks
Constipation
Time frame: 4, 8, 13 and 17 weeks
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 14 Jan 2019.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
15 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Infant Formula with prebiotics and Standard Infant Formula in people with Growth, run by Nutricia Research at 15 sites in 6 countries.
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 9 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 14 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in Poland, Spain, France, Germany, Finland and 1 more country. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Weight gain (time frame: 17 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Jan 2019.