CClinicalTrials.gg
CompletedNCT06646458Updated Jul 25, 2025

A Explorative Pilot Study to Gain Insights for a New Senior Milk Powder

An interventional study of Healthy Elderly Volunteers in Healthy Volunteers and Healthy Elderly, sponsored by Danone Nutricia. Completed at 1 site in China. Open to participants aged 50 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-07-25.

Sponsored by Danone Nutricia · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Not applicable
Ages
50 Years to 70 Years
Sex
All
01

Study 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 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:

  1. Microbiological change from stool samples collected at baseline and in the days after study product usage
  2. Gastrointestinal function and acceptance assessed during the study period
  3. Health related outcomes assessed via wearable device
  4. Any safety events

No comparison group

Participants will:

  1. Take study product
  2. Visit the study site
  3. Collect the stool sample
  4. Record daily gastrointestinal tolerance and health data
02

Conditions studied

  • Healthy Volunteers
  • Healthy Elderly
03

In context

Lead sponsor

Danone Nutricia is the lead sponsor of 8 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
50 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

    • 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*:
  • 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.

Exclusion criteria

Exclusion Criteria:

    • 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.
      • 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.
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
30 participants (actual)

Study arms

  • Experimental
    Milk Powder (study product) usage group

    Investigational Product Participants in this arm will need to take 2 times every day from baseline visit to 28 days.

    Other: Healthy Elderly Volunteers

Interventions

  • OtherHealthy Elderly Volunteers

    Take the elderly milk power 2 times every day up to 28 days

06

What researchers measure

Primary outcomes

  1. Gastrointestinal (GI) function Questionnaire

    Gastrointestinal symptoms assessed the tolerance of product via the Incidence of gastrointestinal discomfort

    Time frame: 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

    Time frame: from baseline to the end of study at 28 days

Other outcomes

  1. Sleep quality analysis from wearable device

    The sleep quality collected from wearable devices changes from baseline to end of treatment.

    Time frame: from baseline (0 days) to end of treatment at 28 days

07

Study locations

1 site
  • Lisheng Scientific Lab
    Shanghai, Shanghai Municipality, China
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 25, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06646458
Lead sponsor
Danone Nutricia
Responsible party
Sponsor
First posted
Oct 17, 2024
Start date
Feb 7, 2025
Primary completion
Mar 14, 2025
Completion
Mar 14, 2025
Last update
Jul 25, 2025

Study contacts

Charlie Zhang, MD
principal investigator · Lisheng Scientific Lab

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.

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