Ignite Creation Date:
2025-12-25 @ 4:25 AM
Ignite Modification Date:
2026-03-06 @ 5:28 AM
Study NCT ID:
NCT06481020
Status:
RECRUITING
Last Update Posted:
2024-07-01
First Post:
2024-06-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Plant Sterols on Cardiovascular Markers, Microbiota and Sterol Metabolism (Cardiofoodsterol)
Sponsor:
University of Valencia
Organization:
Study Overview
Official Title:
Effect of Plant Sterols on Inflammatory, Endothelial Function and Oxidative Stress Markers, Microbiota and Sterol Metabolism in a Cardiovascular Risk Population
Status:
RECRUITING
Status Verified Date:
2024-06
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:
Potential cholesterol-lowering effect of a regular intake of a plant sterol (PS)-containing food supplement, in overweight/obese type 1 or 2, normoglycemic/pre-diabetic, with LDL-cholesterol values \> 115 mg/dl and not pharmacologically treated participants treated with the PS-containing food supplement or placebo supplement.
Detailed Description:
Cardiovascular disease (CVD) is the leading cause of death worldwide, with hypercholesterolemia being one of the main risk factors for CVD. The deposition and oxidation of LDL-cholesterol particles triggers a series of molecular events favoring chronic low-grade inflammation, endothelial dysfunction and oxidative stress. This situation promotes atherogenesis thus increasing cardiovascular risk. Obesity favors the secretion of pro-inflammatory mediators and promotes the recruitment of macrophages to adipose tissue, insulin resistance, hyperglycemia and hyperlipidemia, thus increasing the risk of CVD. In addition, obesity has been associated with gut dysbiosis, which in turn is associated with atherosclerosis in some studies. Beneficial effects of PS on LDL-cholesterol and inflammatory, endothelial dysfunction and oxidative stress markers have been reported by several clinical trials. A meta-analysis suggests a lowering effect of PS on body mass index (BMI) in participants with BMI\>25. Furthermore, the consumption of PS has been beneficially associated in in vitro studies with changes in intestinal microbial profile, sterol metabolism and short chain fatty acids (SCFA) production. Therefore, the hypothesis is if the consumption of PS as a food supplementation could reduce cardiovascular risk. The present study aims to evaluate the LDL-cholesterol serum levels after regular intake of a food supplement containing PS (2 g/day) in overweight/obese type 1 or 2 patients, normoglycemic /pre-diabetic and with LDL-cholesterol values \> 115 mg/dl not pharmacologically treated. This is a crossover study with 21 participants (intake of a food supplement containing PS) and 21 participants (intake of excipient-based placebo), with a first intervention period of 8 weeks. After a 6-week washout period, the treatments are switched, with a second intervention period of 8 weeks. In addition, to the LDL-cholesterol lowering assessment, other biochemical, hematological, inflammatory, endothelial dysfunction and oxidative stress parameters are assessed in serum samples. Moreover, sterol and metabolite profiling in serum and feces, microbiota modulation, anthropometric measurements and body composition, bioimpedance, dietary intake and physical activity questionnaire are evaluated. All parameters are evaluated at the beginning (weeks 0 and 14) and at the end of each intervention period (weeks 8 and 22).
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?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| PID2019-104167RB-I00 | OTHER_GRANT | MCIN/AEI/10.13039/501100011033 | View |