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

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.

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

Study Overview

• Status: Completed
• Conditions: Healthy Elderly; Healthy Volunteers
• Intervention / Treatment: Other: Healthy Elderly Volunteers

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China
      • Lisheng Scientific Lab

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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:

• • 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; Take the elderly milk power 2 times every day up to 28 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gastrointestinal (GI) function Questionnaire	Gastrointestinal symptoms assessed the tolerance of product via the Incidence of gastrointestinal discomfort	from baseline (0 day) to the end of treatment at 28 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Microbiological analysis	Assess the change of intestinal bacterial distribution from stool samples collected at baseline and days after treatment compelte	from baseline to the end of study at 28 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sleep quality analysis from wearable device	The sleep quality collected from wearable devices changes from baseline to end of treatment.	from baseline (0 days) to end of treatment at 28 days

Collaborators and Investigators

• Sponsor: Danone Nutricia
• Investigators: Principal Investigator: Charlie Zhang, MD, Lisheng Scientific Lab

Study record dates

Study Major Dates

• Study Start (Actual): February 7, 2025
• Primary Completion (Actual): March 14, 2025
• Study Completion (Actual): March 14, 2025

Study Registration Dates

• First Submitted: October 1, 2024
• First Submitted That Met QC Criteria: October 16, 2024
• First Posted (Actual): October 17, 2024

Study Record Updates

• Last Update Posted (Actual): July 25, 2025
• Last Update Submitted That Met QC Criteria: July 24, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: NELN202405A

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No