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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:
No comparison group
Participants will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Healthy Elderly Volunteers | Other | Take the elderly milk power 2 times every day up to 28 days |
|
| 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 |
| 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 |
| 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 |
Inclusion Criteria:
• Age 50-70 years (bounds included)
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.
Exclusion Criteria:
• Known / Existing gastrointestinal diseases or disorders diagnosed by a physician that may interfere with study.
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| Name | Affiliation | Role |
|---|---|---|
| Charlie Zhang, MD | Lisheng Scientific Lab | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lisheng Scientific Lab | Shanghai | Shanghai Municipality | China |
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