Ignite Creation Date:
2025-12-24 @ 11:35 PM
Ignite Modification Date:
2025-12-25 @ 9:25 PM
Study NCT ID:
NCT06657456
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-05-21
First Post:
2024-10-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Impact of Phytosterol-Rich Extract on Lipid Profile
Sponsor:
Desirée Victoria Montesinos
Organization:
Study Overview
Official Title:
Nutritional Intervention Study of the Effect of a Phytosterol-rich Extract on Lipid Profile.
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-05
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 aim of this randomized, parallel, two-arm, placebo-controlled, triple-blind clinical trial is to evaluate the efficacy of a phytosterol- and phytostanol-rich extract on lipid profile parameters in individuals with hypercholesterolemia, focusing primarily on total cholesterol and LDL cholesterol levels.
Detailed Description:
The duration of the study will be 56 days during which the investigational product or placebo will be consumed according to the assignment.
Subjects will be randomized to each of the study arms (consumption of the experimental product or control product).
Subjects will be randomized to each of the study arms (consumption of the experimental product or control product).
Study Oversight
Has Oversight DMC:
False
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?:
False
Is an FDA AA801 Violation?: