GrowthNCT05757323
The Effects of an Infant Formula Containing Hydrolysed Proteins on Growth and Tolerance in Healthy Term Infants
A study testing infant formula based on hydrolyzed protein and infant formula based on intact protein in people with Growth, run by FrieslandCampina at 3 sites in Greece.
Trial summary
In this clinical trial, weight gain (primary objective), and additional anthropometry (secondary objectives), of infants exclusively consuming a hydrolysed protein-based infant formula were evaluated and compared to a standard intact protein-based formula over a period of at least three months, until the age of 17… Read more about this study
- Who is it for?
- Ages 5 to 28 daysHealthy volunteers can take part
- Conditions the study is for
- Growth
- What is being tested?
- infant formula based on hydrolyzed protein and infant formula based on intact protein
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 345 participants
- Where
- 3 sitesGreece
- Study dates
- 6 Aug 2021to 24 Oct 2022
- 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 5 to 28 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Full-term infants (born at gestational age =37 weeks).
- Healthy birthweight (according to WHO Child Growth Standards): between 2500 and 4200 g, retrieved from medical records
- Boys and girls
- Apparently healthy at birth and screening
- Weight-for-age Z-score (WAZ), weight-for-length (WHZ), and length-for-age (LAZ) Z-scores at screening within the normal range according to WHO Child Growth Standards (i.e. -2 = WAZ,WHZ,LAZ = 2)
- Age at enrolment: =28 days of age
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- Exclusively formula fed for at least 5 days prior to inclusion
- Exclusively formula fed during the entire intervention period
- Parents agreeing to initiate complementary feeding after finalization of the study
- Being available for follow up until the age of approximately 3.5 months
- Written informed consent from parent(s) and/or legal guardian(s) aged =18 years
Who cannot join
- Gestational age <37 weeks
- Birth weight <2500 g or >4200 g
- Age at enrolment: >28 days
- Severe acquired or congenital diseases, mental or physical disorders, including cow's milk protein allergy, lactose intolerance and diagnosed medical conditions that are known to affect growth (i.e. GI disorders)
- Illness at screening/inclusion
- Incapability of parents to comply with the study protocol
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- Illiterate parents (i.e. not able to read and write in local language)
- Participation in another clinical trial
- Unwillingness to accept the formula supplied by the study as the only formula for their child during study participation
- infants fed a special diet other than standard, non-hydrolysed, cow's or goat's milk based infant formula
Trial locations and contacts
3 sites in 1 country.
Greece3 sites
Harokopio University
Athens, Thiseos 70, Kallithea 176 71
Department of Nutritional Sciences, International Hellenic University
Thessaloniki, 55535
Department of Nutrition and Dietetics, University of Thessaly
Trikala, Thessaly, 42132
About this study
Official title: A Randomized, Controlled, Double-blind Parallel Group Trial to Study the Effects of an Infant Formula Containing Partially Hydrolysed Proteins on Growth and Tolerance in Healthy Term Infants
In this clinical trial, weight gain (primary objective), and additional anthropometry (secondary objectives), of infants exclusively consuming a hydrolysed protein-based infant formula were evaluated and compared to a standard intact protein-based formula over a period of at least three months, until the age of 17 weeks.
Read the detailed description
In this clinical trial, weight gain (primary objective), and additional anthropometry (secondary objectives), of infants exclusively consuming a hydrolysed protein-based infant formula were evaluated and compared to a standard intact protein-based formula over a period of at least three months, at the age of 8, 13, and 17 weeks. 345 healthy term infants, exclusively formula-fed were included.
- Conditions
- Growth
- Being tested
- infant formula based on hydrolyzed protein, infant formula based on intact protein
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
infant formula based on hydrolyzed proteinOther
infant formula based on hydrolysed protein
infant formula based on intact proteinOther
infant formula based on intact protein
| Study group | Role | What they receive |
|---|---|---|
| test formula | Experimental | hydrolysed protein-based infant formula Receives: Other: infant formula based on hydrolyzed protein |
| control formula | Active comparator | standard intact protein-based formula Receives: Other: infant formula based on intact protein |
What is being measured
The primary outcome is the main question the study is designed to answer.
weight gain
weight gain in g/day
Measured: until 17 weeks of age
Secondary outcomes (9)
Weight
Weight in g
Measured: until 17 weeks of age
Length
length in cm
Measured: until 17 weeks of age
head circumference
head circumference in cm
Measured: until 17 weeks of age
BMI
BMI in kg/m2
Measured: until 17 weeks of age
WAZ
weight-for-age Z-score
Measured: until 17 weeks of age
LAZ
length-for-age Z-score
Measured: until 17 weeks of age
WHZ
weight-for-height Z-score
Measured: until 17 weeks of age
BMI-for-age Z-score
BMI-for-age Z-score
Measured: until 17 weeks of age
head circumference-for-age Z-score
head circumference-for-age Z-score
Measured: until 17 weeks of age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2023
- Study start6 Aug 2021
- Primary completion24 Oct 2022
- Study completion24 Oct 2022
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 GrowthStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 345 participants (actual)
Sponsor and investigators
- Lead sponsor
- FrieslandCampina
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yannis Manios, Prof, Principal investigator, Harokopio University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05757323
- Sponsor's protocol ID
- HerA
- Status last verified
- Sep 2023
- First submitted
- 24 Feb 2023
- Last updated
- 22 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Kantaras P, Kokkinopoulou A, Hageman JHJ, Hassapidou M, Androutsos O, Kanaki M, Bovee-Oudenhoven I, Karaglani E, Kontochristopoulou AM, Bos R, Manios Y. Growth and gut comfort of healthy term infants exclusively fed with a partially hydrolysed protein-based infant formula: a randomized controlled double-blind trial. Front Pediatr. 2024 May 17;12:1328709. doi: 10.3389/fped.2024.1328709. eCollection 2024.
PubMed 38827219
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Controlled, Double-blind Parallel Group Trial to Study the Effects of an Infant Formula Containing Partially Hydrolysed Proteins on Growth and Tolerance in Healthy Term Infants
- ClinicalTrials.gov ID
- NCT05757323
- Acronym / sponsor ID
- HerA
- Conditions
- Growth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 345 participants (actual)
- Lead sponsor
- FrieslandCampinaIndustry (pharma, biotech, devices)
- Study start
- 6 Aug 2021 (actual)
- Primary completion
- 24 Oct 2022 (actual)
- Study completion
- 24 Oct 2022 (actual)
- First posted
- 7 Mar 2023 (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.
In this clinical trial, weight gain (primary objective), and additional anthropometry (secondary objectives), of infants exclusively consuming a hydrolysed protein-based infant formula were evaluated and compared to a standard intact protein-based formula over a period of at least three months, until the age of 17 weeks.
Detailed description
In this clinical trial, weight gain (primary objective), and additional anthropometry (secondary objectives), of infants exclusively consuming a hydrolysed protein-based infant formula were evaluated and compared to a standard intact protein-based formula over a period of at least three months, at the age of 8, 13, and 17 weeks. 345 healthy term infants, exclusively formula-fed were included.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| test formula | Experimental | Other: infant formula based on hydrolyzed proteinhydrolysed protein-based infant formula |
| control formula | Active comparator | Other: infant formula based on intact proteinstandard intact protein-based formula |
Who may qualify
- Ages
- 5 to 28 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (11 listed)
- Full-term infants (born at gestational age =37 weeks).
- Healthy birthweight (according to WHO Child Growth Standards): between 2500 and 4200 g, retrieved from medical records
- Boys and girls
- Apparently healthy at birth and screening
- Weight-for-age Z-score (WAZ), weight-for-length (WHZ), and length-for-age (LAZ) Z-scores at screening within the normal range according to WHO Child Growth Standards (i.e. -2 = WAZ,WHZ,LAZ = 2)
Key exclusion criteria (10 listed)
- Gestational age <37 weeks
- Birth weight <2500 g or >4200 g
- Age at enrolment: >28 days
- Severe acquired or congenital diseases, mental or physical disorders, including cow's milk protein allergy, lactose intolerance and diagnosed medical conditions that are known to affect growth (i.e. GI disorders)
- Illness at screening/inclusion
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 based on hydrolyzed proteininfant formula based on hydrolysed protein | Other | test formula |
| infant formula based on intact proteininfant formula based on intact protein | Other | control formula |
Primary outcome
weight gain
Time frame: until 17 weeks of age
weight gain in g/day
9 secondary outcomes
Weight
Time frame: until 17 weeks of age
Length
Time frame: until 17 weeks of age
head circumference
Time frame: until 17 weeks of age
BMI
Time frame: until 17 weeks of age
WAZ
Time frame: until 17 weeks of age
LAZ
Time frame: until 17 weeks of age
WHZ
Time frame: until 17 weeks of age
BMI-for-age Z-score
Time frame: until 17 weeks of age
head circumference-for-age Z-score
Time frame: until 17 weeks of age
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 22 Sep 2023.
- Derived from this study: PubMed 38827219Kantaras P, Kokkinopoulou A, Hageman JHJ, Hassapidou M, Androutsos O, Kanaki M, Bovee-Oudenhoven I, Karaglani E, Kontochristopoulou AM, Bos R, Manios Y. Growth and gut comfort of healthy term infants exclusively fed with a partially hydrolysed protein-based infant formula: a randomized controlled double-blind trial. Front Pediatr. 2024 May 17;12:1328709. doi: 10.3389/fped.2024.1328709. eCollection 2024.
- first registration of the trial (register is closed, so not able to enter new data)Link provided by the sponsor.
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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.
Yannis Manios, Prof principal investigator
Harokopio University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing infant formula based on hydrolyzed protein and infant formula based on intact protein in people with Growth, run by FrieslandCampina at 3 sites in Greece.
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 11 inclusion and 10 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 22 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Greece. 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.
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: until 17 weeks of age). 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 NCT05757323, 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 22 Sep 2023.