Ignite Creation Date:
2024-05-06 @ 8:05 PM
Last Modification Date:
2024-10-26 @ 3:20 PM
Study NCT ID:
NCT06247137
Status:
COMPLETED
Last Update Posted:
2024-04-26
First Post:
2024-01-30
Brief Title:
Effect of a Food Supplementation With a Combined Food Supplement on Lipid Pattern Indexes of Non-alcoholic Fatty Liver Disease and Systemic Inflammation
Sponsor:
University of Bologna
Organization:
University of Bologna
Study Overview
Official Title:
Evaluation of the Effect of a Food Supplementation With a Combined Food Supplement on Lipid Pattern Indexes of Non-alcoholic Fatty Liver Disease and Systemic Inflammation in Healthy Subjects With Suboptimal LDL-C Levels a Two-arm Double-blind Placebo- Controlled Randomized Clinical Trial
Status:
COMPLETED
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:
Several controlled interventional studies have shown that there is a close correlation between cholesterol reduction and cardiovascular risk in fact reductions in serum levels of total cholesterol and low-density lipoprotein cholesterol LDL-C obtained through lifestyle modification or specific drugs result in reductions in the incidence of major coronary events The effectiveness of these interventions has been demonstrated both in subjects in primary prevention and in subjects in secondary prevention
Based on this evidence the National Cholesterol Education Program NCEP has defined in the ATP III report the target values of LDL-C to be reached with interventions on food and or pharmacological habits to perform an effective cardiovascular prevention
Although the atherogenic action of hypercholesterolemia is largely attributable to a direct damage exerted on vascular endothelium recent studies suggest that the activation of a low-grade systemic pro-inflammatory state typical of the patient with cardiovascular risk factors does also play a role in the determinism of endothelial damage and atheroma degeneration of the arteries It is believed that this systemic inflammation as documented by the determination of some humoral signs of inflammation eg C-reactive protein interleukin-6 tumor necrosis factor-α may further contribute to an increase of cardiovascular risk
The inflammatory state can modulate the atherosclerotic process at various levels determining endothelial activation promoting leukocyte chemotaxis in the sub-intimal space of the arterial wall and therefore the formation of an atheromatous plaque rich in inflammatory cells the latter represents the lesion responsible for the vast majority of the coronary and cerebrovascular events observed in subjects with cardiovascular risk factors
Based on this evidence the National Cholesterol Education Program NCEP has defined in the ATP III report the target values of LDL-C to be reached with interventions on food and or pharmacological habits to perform an effective cardiovascular prevention
Although the atherogenic action of hypercholesterolemia is largely attributable to a direct damage exerted on vascular endothelium recent studies suggest that the activation of a low-grade systemic pro-inflammatory state typical of the patient with cardiovascular risk factors does also play a role in the determinism of endothelial damage and atheroma degeneration of the arteries It is believed that this systemic inflammation as documented by the determination of some humoral signs of inflammation eg C-reactive protein interleukin-6 tumor necrosis factor-α may further contribute to an increase of cardiovascular risk
The inflammatory state can modulate the atherosclerotic process at various levels determining endothelial activation promoting leukocyte chemotaxis in the sub-intimal space of the arterial wall and therefore the formation of an atheromatous plaque rich in inflammatory cells the latter represents the lesion responsible for the vast majority of the coronary and cerebrovascular events observed in subjects with cardiovascular risk factors
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