Healthy VolunteersNCT06646458
A Explorative Pilot Study to Gain Insights for a New Senior Milk Powder
A study testing Healthy Elderly Volunteers in people with Healthy Volunteers and Healthy Elderly, run by Danone Nutricia at 1 site in China.
Trial summary
The purpose of this interventional, single-arm pilot study aimed to evaluate the new product that newly developed contains a mixture of prebiotics and probiotics to gain insights of GI function acceptance, microbiological composition and related benefits before and after study product consumption in population aged… Read more about this study
- Who is it for?
- Ages 50 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers, Healthy Elderly
- What is being tested?
- Healthy Elderly Volunteers
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 7 Feb 2025to 14 Mar 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 50 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- • Age 50-70 years (bounds included)
- Body Mass Index (BMI) between 18.5 (bound included) and 30 (bound excluded) kg/m2.
- Ability to comply with the protocol and assessment window:
- Product intake according to instructions.
- Willing to collect, store, deliver stool sample according to instructions.
- Willing to adhere to instructions and restrictions during entire study period*:
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- No probiotic supplementations or products supplemented with probiotics.
- No dietary fiber supplements.
- No medications may modify gastrointestinal function.
- Fluency in speaking, reading and writing in mandarin.
- Capability of the subject to install and use the secure study platform on the smartphone during entire study period.
- Written informed consent. *Overruled in case of medical needs.
Who cannot join
- • Known / Existing gastrointestinal diseases or disorders diagnosed by a physician that may interfere with study.
- Known / Existing milk protein allergies, lactose intolerance or other allergies to product ingredients.
- Known / Existing immune diseases or disorders diagnosed by a physician that may interfere with study.
- Use of any medication may modify gastrointestinal function: tricyclic antidepressants, SSRIs/antidepressants, opioids, ACE inhibitor, bate sympathomimetics, systemic antibiotics, intestinal antiseptics, anti-inflammatory medicines (including nonsteroidal anti-inflammatory drugs [NSAIDs] and aspirin), anti-histamines, steroids, corticosteroids, laxatives, anti-diarrhoea medication, prokinetics/dopamine-antagonists, metformin, statins, or any other stomach medication (including proton pump inhibitor [PPIs], antiacids, and antihistamine2 blockers) within 8 weeks prior to enrolment.
- Consumption of probiotic supplementations or products supplemented with probiotics within 4 weeks prior to enrolment.
- Subject following a special diet, including but not limited to vegan diet, ketogenic diet, low fiber diet, thickening diet etc.
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- Incapability to comply with protocol as per the judgement of the investigator.
- Participation in any other studies involving investigational or marketed products concomitantly or 2 weeks prior to enrolment.
- Employees and/or children/family member or relatives of employees of Danone or the participating site.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Xuanwu Pilot: A Prospective, Interventional, Single-arm, Before-and-after Explorative Pilot to Gain Insights on Gastrointestinal and Related Benefits of the New Senior Milk Powder
The purpose of this interventional, single-arm pilot study aimed to evaluate the new product that newly developed contains a mixture of prebiotics and probiotics to gain insights of GI function acceptance, microbiological composition and related benefits before and after study product consumption in population aged between 50-70 years.
This project also serves the purpose of formulating conceptual hypothesis and directions of exploration for future research.
Read more
The main questions it aims to answer are:
- Microbiological change from stool samples collected at baseline and in the days after study product usage
- Gastrointestinal function and acceptance assessed during the study period
- Health related outcomes assessed via wearable device
- Any safety events
No comparison group
Participants will:
- Take study product
- Visit the study site
- Collect the stool sample
- Record daily gastrointestinal tolerance and health data
- Conditions
- Healthy Volunteers, Healthy Elderly
- Being tested
- Healthy Elderly Volunteers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Healthy Elderly VolunteersOther
Take the elderly milk power 2 times every day up to 28 days
| Study group | Role | What they receive |
|---|---|---|
| Milk Powder (study product) usage group | Experimental | Investigational Product Participants in this arm will need to take 2 times every day from baseline visit to 28 days. Receives: Other: Healthy Elderly Volunteers |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gastrointestinal (GI) function Questionnaire
Gastrointestinal symptoms assessed the tolerance of product via the Incidence of gastrointestinal discomfort
Measured: from baseline (0 day) to the end of treatment at 28 days
Secondary outcomes (1)
Microbiological analysis
Assess the change of intestinal bacterial distribution from stool samples collected at baseline and days after treatment compelte
Measured: from baseline to the end of study at 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2024
- Study start7 Feb 2025
- Primary completion14 Mar 2025
- Study completion14 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Danone Nutricia
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Charlie Zhang, MD, Principal investigator, Lisheng Scientific Lab
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06646458
- Sponsor's protocol ID
- NELN202405A
- Status last verified
- Jul 2025
- First submitted
- 1 Oct 2024
- Last updated
- 25 Jul 2025
- 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 25 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Xuanwu Pilot: A Prospective, Interventional, Single-arm, Before-and-after Explorative Pilot to Gain Insights on Gastrointestinal and Related Benefits of the New Senior Milk Powder
- ClinicalTrials.gov ID
- NCT06646458
- Acronym / sponsor ID
- NELN202405A
- Conditions
- Healthy Volunteers, Healthy Elderly
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Danone NutriciaIndustry (pharma, biotech, devices)
- Study start
- 7 Feb 2025 (actual)
- Primary completion
- 14 Mar 2025 (actual)
- Study completion
- 14 Mar 2025 (actual)
- First posted
- 17 Oct 2024 (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.
The purpose of this interventional, single-arm pilot study aimed to evaluate the new product that newly developed contains a mixture of prebiotics and probiotics to gain insights of GI function acceptance, microbiological composition and related benefits before and after study product consumption in population aged between 50-70 years.
This project also serves the purpose of formulating conceptual hypothesis and directions of exploration for future research.
The main questions it aims to answer are:
- Microbiological change from stool samples collected at baseline and in the days after study product usage
- Gastrointestinal function and acceptance assessed during the study period
- Health related outcomes assessed via wearable device
- Any safety events
No comparison group
Participants will:
- Take study product
- Visit the study site
- Collect the stool sample
- Record daily gastrointestinal tolerance and health data
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Milk Powder (study product) usage group | Experimental | Other: Healthy Elderly VolunteersInvestigational Product Participants in this arm will need to take 2 times every day from baseline visit to 28 days. |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- • Age 50-70 years (bounds included)
- Product intake according to instructions.
- Willing to collect, store, deliver stool sample according to instructions.
- No probiotic supplementations or products supplemented with probiotics.
- No dietary fiber supplements.
Key exclusion criteria (9 listed)
- • Known / Existing gastrointestinal diseases or disorders diagnosed by a physician that may interfere with study.
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 |
|---|---|---|
| Healthy Elderly VolunteersTake the elderly milk power 2 times every day up to 28 days | Other | Milk Powder (study product) usage group |
Primary outcome
Gastrointestinal (GI) function Questionnaire
Time frame: from baseline (0 day) to the end of treatment at 28 days
Gastrointestinal symptoms assessed the tolerance of product via the Incidence of gastrointestinal discomfort
1 secondary outcome
Microbiological analysis
Time frame: from baseline to the end of study at 28 days
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 25 Jul 2025.
- 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.
Charlie Zhang, MD principal investigator
Lisheng Scientific Lab
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Healthy Elderly Volunteers in people with Healthy Volunteers and Healthy Elderly, run by Danone Nutricia at 1 site in China.
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 12 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 25 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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?
Gastrointestinal (GI) function Questionnaire (time frame: from baseline (0 day) to the end of treatment at 28 days). 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 25 Jul 2025.