Ignite Creation Date:
2024-05-06 @ 8:24 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06368258
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-16
First Post:
2024-04-07
Brief Title:
Middle Term Effect of Red Yeast Rice on Plasma Lipids and Proteoma in Individuals With Suboptimal Cholesterolemia
Sponsor:
University of Bologna
Organization:
University of Bologna
Study Overview
Official Title:
Randomized Clinical Trial to Evaluate the Middle Term Effect of a Dietary Supplement Containing Red Yeast Rice Total Monacolin 3 mgDose or Placebo on Plasma Lipids and Proteoma in Subjects With Suboptimal Cholesterolemia
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The primary purpose of our research will be to evaluate if in healthy subjects with a low- moderate cardiovascular risk CV risk1 but 5 evidenced by sub-optimal cholesterol levels as per ESCEAS guidelines LDL cholesterol 115 mgdL 190 mgdL supplementation with a red yeast rice food supplement containing less than 3 mg total monacolins per daily dose is able to significantly influence plasma lipid levels Furthermore liver and muscle proteomic pattern and vascular response to dietary supplementation will be investigated
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None