Ignite Creation Date:
2026-03-26 @ 3:21 PM
Ignite Modification Date:
2026-04-01 @ 10:55 PM
Study NCT ID:
NCT07295327
Status:
RECRUITING
Last Update Posted:
2025-12-19
First Post:
2025-12-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Two Food Supplements on Lipid Profile in Patients With Mild Hypercholesterolemia
Sponsor:
Fondazione IRCCS Policlinico San Matteo di Pavia
Organization:
Study Overview
Official Title:
Randomized and Comparative Clinical Study on the Lipid-lowering Efficacy and Tolerability of Two Food Supplements in Mild Hypercholesterolemia
Status:
RECRUITING
Status Verified Date:
2025-12
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 outcome is to evaluate the effect of Cynacol on the change in LDL-C levels compared to Metacol after 90 days of supplementation.
The secondary outcomes are to evaluate:
\- the change of TC, non-HDL cholesterol (non-HDL-C), apolipoprotein B (apoB), Tg, HDL-C levels after 90 days of supplementation with Cynacol compared to Metacol. The safety outcome is collection of the adverse events not related, related or possibly related to the study products.
The secondary outcomes are to evaluate:
\- the change of TC, non-HDL cholesterol (non-HDL-C), apolipoprotein B (apoB), Tg, HDL-C levels after 90 days of supplementation with Cynacol compared to Metacol. The safety outcome is collection of the adverse events not related, related or possibly related to the study products.
Detailed Description:
In the screening visit subject's demographic data, medical history, co-morbidities and concomitant medication will be collected. Patients with documented hypercholesterolemia (LDL-C values between 115 and 190 mg/dl) will be evaluate. Blood sample analysis will be prescribed to be performed before the next visit for the evaluation of TC, HDL-C, Tg, apoB, fasting plasma glucose (FPG), creatinine, uric acid, alanine aminotransferase (ALT), aspartate aminotransferase (AST) and creatinine phosphokinase (CPK). At the baseline visit, a computerized medical record will be compiled where the following data will be recorded: vital signs \[weight, height, BMI, systolic blood pressure (SBP) and diastolic blood pressure (DBP)\] and the laboratory tests (TC, HDL-C, Tg, apoB, FPG, creatinine, uric acid, ALT, AST and CPK). The subjects will be randomized in one of the 2 groups to receive Cynacol or Metacol. A sufficient amount of study product for 90 days will be delivered. Standardized diet and physical activity advice will be prescribed. Blood sample analysis will be prescribed to be performed before the next visit for the evaluation of TC, HDL-C, Tg, apoB, FPG, creatinine, uric acid, ALT, AST and CPK. After 45 days of treatment, following blood samples collection, vital signs and laboratory tests will be recorded. Any adverse events eventually occurred will be collected. After 90 days of treatment, following blood samples collection, vital signs and laboratory tests will be recorded. Any adverse events eventually occurred will be collected. The primary outcome is to evaluate the effect of Cynacol on the change in LDL-C levels compared to Metacol after 90 days of supplementation.
The secondary outcomes are to evaluate:
\- the change of TC, non-HDL cholesterol (non-HDL-C), apolipoprotein B (apoB), Tg, HDL-C levels after 90 days of supplementation with Cynacol compared to Metacol. The safety outcome is collection of the adverse events not related, related or possibly related to the study products.
The secondary outcomes are to evaluate:
\- the change of TC, non-HDL cholesterol (non-HDL-C), apolipoprotein B (apoB), Tg, HDL-C levels after 90 days of supplementation with Cynacol compared to Metacol. The safety outcome is collection of the adverse events not related, related or possibly related to the study products.
Study Oversight
Has Oversight DMC:
True
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?: