Clinical trial NCT06646458: A Explorative Pilot Study to Gain Insights for a New Senior Milk Powder
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
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Healthy Volunteers
Healthy Elderly
Lead sponsor: Danone Nutricia
Sponsor class: INDUSTRY
First posted: 2024-10-17
Enrollment: 30
Sex: ALL
Minimum age (years): 50
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief 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


Eligibility criteria: 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.

Primary outcomes:
measure: Gastrointestinal (GI) function Questionnaire
timeFrame: from baseline (0 day) to the end of treatment at 28 days
Secondary outcomes:
measure: Microbiological analysis
timeFrame: from baseline to the end of study at 28 days
Other outcomes:
measure: Sleep quality analysis from wearable device
timeFrame: from baseline (0 days) to end of treatment at 28 days
Locations:
city: Shanghai
country: China
facility: Lisheng Scientific Lab
state: Shanghai
Study officials:
affiliation: Lisheng Scientific Lab
name: Charlie Zhang, MD
role: PRINCIPAL_INVESTIGATOR
References: