Healthy SubjectsNCT06122272
An Exploratory Trial in Hong Kong to Explore the Effect of a New Formula
A study testing Test Formula in people with Healthy Subjects, run by Danone Nutricia at 2 sites in 2 countries.
Trial summary
This is an exploratory study with the aim to gain insight and potentially generate hypotheses on health benefits of feeding with study product. This study explores in healthy subjects the effect of feeding with the test product compared to the control product in early life. Read more about this study
- Who is it for?
- Ages 6 to 6 monthsHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects
- What is being tested?
- Test Formula
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 19 Dec 2023to 30 May 2025
- 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 6 to 6 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Healthy, singleton, term born infants.
- Infants aged 6 months(± 2 weeks) at enrolment.
- Infants fed with formula (with or without additional weaning foods or drinks) before enrolment.
- Written informed consent (IC) from parent(s) and/or legally acceptable representative(s) aged ≥18 years at enrolment.
Who cannot join
- Infants who require a special diet other than Formula with intact cow's milk protein.
- Infants known or suspected to have cow's milk, fish protein, and/or soy allergy and/or lactose intolerance.
- Infants with current or previous illnesses/conditions and/or known or suspected congenital diseases or malformations which could interfere with the study outcomes, as per investigator's clinical judgement.
- Infants with previous, current, or intended participation in any other clinical study involving investigational or marketed products.
- Incapability of infants' parents and/or legally acceptable representative(s) to comply with study protocol as per the judgement of the investigator or investigator's uncertainty about the willingness or ability of parents legally acceptable representative(s) to comply with the protocol requirements.
- Employees and/or infants/family members or relatives of employees of Danone Nutricia, the participating sites, or any other nutrition company that develops Infant, Follow On or Young Child formulae.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: An Exploratory, Randomised, Open Label, Controlled, Multicentre Clinical Trial in Hong Kong to Explore the Effect of a New Nutritional Formula on Body Composition and Other Health Outcomes in Early Life.
This is an exploratory study with the aim to gain insight and potentially generate hypotheses on health benefits of feeding with study product. This study explores in healthy subjects the effect of feeding with the test product compared to the control product in early life.
Read the detailed description
- Key exploratory objective is to find an effect on body composition.
- Other exploratory objectives are to find an effect on growth parameters.
- Safety and tolerance and the user experience will be investigated.
- Conditions
- Healthy Subjects
- Being tested
- Test Formula, Control Formula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Test FormulaOther
The duration of the study for each subject from enrolment to final visit, is 12 months. Test Formula will be provided during this 12 month.
Control FormulaOther
The duration of the study for each subject from enrolment to final visit, is 12 months. Control Formula will be provided during this 12 month.
| Study group | Role | What they receive |
|---|---|---|
| Test products: | Experimental | New formula for healthy term infants Receives: Other: Test Formula |
| Control products | Active comparator | Standard, commercially available infant formula for healthy term infants Receives: Other: Control Formula |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body composition
Fat mass (kg)
Measured: Every 6 months, up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2023
- Study start19 Dec 2023
- Primary completion30 May 2025
- Study completion30 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy SubjectsStudies 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
- None (open label)
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Danone Nutricia
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06122272
- Sponsor's protocol ID
- NELN202110A
- Status last verified
- Mar 2025
- First submitted
- 28 Jun 2023
- Last updated
- 5 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory, Randomised, Open Label, Controlled, Multicentre Clinical Trial in Hong Kong to Explore the Effect of a New Nutritional Formula on Body Composition and Other Health Outcomes in Early Life.
- ClinicalTrials.gov ID
- NCT06122272
- Acronym / sponsor ID
- NELN202110A
- Conditions
- Healthy Subjects
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Danone NutriciaIndustry (pharma, biotech, devices)
- Study start
- 19 Dec 2023 (actual)
- Primary completion
- 30 May 2025 (actual)
- Study completion
- 30 May 2025 (actual)
- First posted
- 8 Nov 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.
This is an exploratory study with the aim to gain insight and potentially generate hypotheses on health benefits of feeding with study product. This study explores in healthy subjects the effect of feeding with the test product compared to the control product in early life.
Detailed description
- Key exploratory objective is to find an effect on body composition.
- Other exploratory objectives are to find an effect on growth parameters.
- Safety and tolerance and the user experience will be investigated.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test products: | Experimental | Other: Test FormulaNew formula for healthy term infants |
| Control products | Active comparator | Other: Control FormulaStandard, commercially available infant formula for healthy term infants |
Who may qualify
- Ages
- 6 to 6 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Healthy, singleton, term born infants.
- Infants aged 6 months(± 2 weeks) at enrolment.
- Infants fed with formula (with or without additional weaning foods or drinks) before enrolment.
- Written informed consent (IC) from parent(s) and/or legally acceptable representative(s) aged ≥18 years at enrolment.
Key exclusion criteria (6 listed)
- Infants who require a special diet other than Formula with intact cow's milk protein.
- Infants known or suspected to have cow's milk, fish protein, and/or soy allergy and/or lactose intolerance.
- Infants with current or previous illnesses/conditions and/or known or suspected congenital diseases or malformations which could interfere with the study outcomes, as per investigator's clinical judgement.
- Infants with previous, current, or intended participation in any other clinical study involving investigational or marketed products.
- Incapability of infants' parents and/or legally acceptable representative(s) to comply with study protocol as per the judgement of the investigator or investigator's uncertainty about the willingness or ability of parents legally acceptable representative(s) to comply with the protocol requirements.
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 |
|---|---|---|
| Test FormulaThe duration of the study for each subject from enrolment to final visit, is 12 months. Test Formula will be provided during this 12 month. | Other | Test products: |
| Control FormulaThe duration of the study for each subject from enrolment to final visit, is 12 months. Control Formula will be provided during this 12 month. | Other | Control products |
Primary outcome
Body composition
Time frame: Every 6 months, up to 12 months
Fat mass (kg)
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 5 Aug 2025.
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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.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Test Formula in people with Healthy Subjects, run by Danone Nutricia at 2 sites in 2 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 4 inclusion and 6 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 5 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China, Hong Kong. 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?
Body composition (time frame: Every 6 months, up to 12 months). 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 5 Aug 2025.