Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06560840
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-14
Brief Title:
Effectiveness of Gut Microbiota-targeted Diatery Intervention Among Older People Living With HIV
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Effectiveness of Gut Microbiota-targeted Diatery Intervention in Preventing Atherosclerotic Cardiovascular Disease Among Older People Living With HIV
Status:
RECRUITING
Status Verified Date:
2024-09
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 goal of this clinical trial is to conduct a dietary intervention targeting HIV specific gut microbiota alterations for primary atherosclerotic cardiovascular disease ASCVD prevention and evaluate its effectiveness in preventing ASCVD among older people living with HIV PLWH
Detailed Description:
The investigators utilize a pragmatic randomized controlled trial design to evaluate the effectiveness of dietary intervention in real-world conditions without strict control thereby enhancing the generalizability and clinical applicability of our study findings Participants at Shenzhen Third Peoples Hospital exhibiting HIV with CVD risk will be enrolled Upon providing informed consent participants will undergo dynamic randomization into intervention and control groups aiming for a 11 ratio while preserving maximum unpredictability The intervention group will receive the gut microbiota-targeted dietary intervention thrice weekly for 3 months accompanied by bi-weekly healthy diet guidance for the same duration Meanwhile the control group will continue routine follow-up and health education practices The intervention will span three months followed by a three-month follow-up period Data collection will occur at baseline 3 months and 6 months Primary outcomes will assess ASCVD risk via the pooled cohort equation and evaluate gut microbiota diversity and composition Secondary outcomes will encompass biomarkers and predictors associated with atherosclerotic cardiovascular disease as well as symptoms related to the condition
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