Healthy Elderly, Healthy Volunteers
Conditions
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
Interventions
OTHERHealthy Elderly Volunteers
Take the elderly milk power 2 times every day up to 28 days
Sponsors
Danone Nutricia
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to 70 Years
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
* • 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Gastrointestinal (GI) function Questionnaire | 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
| Measure | Time frame | Description |
|---|---|---|
| Microbiological analysis | 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
| Measure | Time frame | Description |
|---|---|---|
| Sleep quality analysis from wearable device | 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. |
Countries
China
Outcome results
None listed