Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06646458
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-01
Brief Title:
A Explorative Pilot Study to Gain Insights for a New Senior Milk Powder
Sponsor:
None
Organization:
None
Study Overview
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None