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OpenTrials
Completed

NCT Number: NCT06646458

A Explorative Pilot Study to Gain Insights for a 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

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Key information

Age range

50 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Lisheng Scientific Lab

Shanghai, Shanghai Municipality, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Healthy Elderly Volunteers

Other

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

Primary outcomes

  1. 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

Secondary outcomes

  1. Microbiological analysis

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

    Assess the change of intestinal bacterial distribution from stool samples collected at baseline and days after treatment compelte

Other outcomes

  1. Sleep quality analysis from wearable device

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

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

Sponsors and collaborators

Lead sponsor

Danone Nutricia

Industry

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Oct 17, 2024
Registry last updated
Jul 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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