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

NCT06646458 | Completed

• 1 other identifier: NELN202405A
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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. 1.Microbiological change from stool samples collected at baseline and in the days after study product usage
2. 2.Gastrointestinal function and acceptance assessed during the study period
3. 3.Health related outcomes assessed via wearable device
4. 4.Any safety events
5. 5.Take study product
6. 6.Visit the study site
7. 7.Collect the stool sample
8. 8.Record daily gastrointestinal tolerance and health data

Conditions

Healthy Volunteers; Healthy Elderly

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Microbiological analysis

  from baseline to the end of study at 28 days

Other Outcomes (1)

• Sleep quality analysis from wearable device

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

Study Arms (1)

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.

Other: Healthy Elderly Volunteers

Interventions

Healthy Elderly Volunteers OTHER

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

Milk Powder (study product) usage group

Eligibility Criteria

• Age: 50 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Danone Nutricia: lead

Study Sites (1)

Lisheng Scientific Lab

Shanghai, Shanghai Municipality, China

Location

Study Officials

• Charlie Zhang, MD

  Lisheng Scientific Lab

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 1, 2024
• First Posted: October 17, 2024
• Study Start: February 7, 2025
• Primary Completion: March 14, 2025
• Study Completion: March 14, 2025
• Last Updated: July 25, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)