Ignite Creation Date:
2024-05-06 @ 12:21 PM
Last Modification Date:
2024-10-26 @ 12:57 PM
Study NCT ID:
NCT03739242
Status:
COMPLETED
Last Update Posted:
2019-10-14
First Post:
2018-11-09
Brief Title:
Effect of a Treatment With a Nutraceutical Combination on Sub-optimal LDL Cholesterol Levels
Sponsor:
A Menarini Industrie Farmaceutiche Riunite Srl
Organization:
A Menarini Industrie Farmaceutiche Riunite Srl
Study Overview
Official Title:
A Randomized Double-blinded Placebo-controlled Clinical Study of the Effects of a Nutraceutical Combination on LDL Cholesterol Levels in Subjects With Sub-optimal Blood Cholesterol Levels
Status:
COMPLETED
Status Verified Date:
2018-11
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:
NATCOL
Brief Summary:
High cholesterol is one of the major controllable risk factor for coronary heart disease It is well demonstrated that drugs that reduce the intestinal absorption of cholesterol or block the synthesis of cholesterol or the association of both can reduce cholesterol and reduce rate of cardiovascular events The trial will evaluate natural alternative to this drug approach testing the effects of a combination of phytosterol a nutritional that reduce cholesterol absorption and fermented red rice a nutritional that reduce the synthesis of cholesterol Subjects with sub optimal blood cholesterol levels matching all the inclusion criteria and none of the exclusion criteria will be treated for 8 weeks with a nutraceutical combination of phytosterols and fermented red rice and will have to maintain during the entire duration of the study the Mediterranean-style diet provided The study will evaluate as primary objective the changes in LDL cholesterol blood levels and more in general the modulation of lipid profile and of others clinical parameters as well as the tolerability
Detailed Description:
The study is made up of four visits distributed over a 10-weeks period
V 1 day -14 - Screening After providing written informed consent tests will be run in order to check the subjects eligibility for the study Subjects will also be given suggestions regarding their diet a Mediterranean-style diet is to be maintained for the entire duration of the study
V2 baseline and Day 0 randomization After confirmation of the subjects eligibility LDL-C and Triglycerides TG criteria confirmed with blood test results eligible subjects will be randomized within 3 days to one of the two treatment groups During this visit an endothelial reactivity test will be performed
V3 28 3 days after Day 0 - Intermediate Blood will be drawn for tests and compliance with treatment will be assessed V4 28 3 days after Visit 3 - End of study Blood tests and an endothelial reactivity test will be performed and treatment compliance will be assessed
Weight waist circumference Index of Central Obesity ICO and Body Mass Index BMI Hepatic Steatosis Index HSI and Lipid Accumulation Product LAP will be measuredcalculated at each visit height at Visit 1
Heart rate and blood pressure will be measured at each visit Adverse events AEs will be collected throughout the study starting from the Informed consent signature
The study will be monitored according to the details specified in the Monitoring Plan The monitor will have the responsibility of reviewing the ongoing study with the Investigator to verify adherence to the protocol and to deal with any problems Case Report Form CRF will be checked for completeness and consistency with the source data and special attention will be dedicated to patient enrolment obtaining signed informed consent occurrence of AEs product accountability and accurate recording of variables The confidentiality of study related documents shall be maintained at all times The Investigator agrees to allow access to all study materials needed for the proper review of study conduct
An independent quality auditinspection at the study site may take place at any time during or after the study The independent auditinspection can be carried out by the Sponsors independent Quality Assurance QA by a Health Authorities or an Ethics Committee EC
V 1 day -14 - Screening After providing written informed consent tests will be run in order to check the subjects eligibility for the study Subjects will also be given suggestions regarding their diet a Mediterranean-style diet is to be maintained for the entire duration of the study
V2 baseline and Day 0 randomization After confirmation of the subjects eligibility LDL-C and Triglycerides TG criteria confirmed with blood test results eligible subjects will be randomized within 3 days to one of the two treatment groups During this visit an endothelial reactivity test will be performed
V3 28 3 days after Day 0 - Intermediate Blood will be drawn for tests and compliance with treatment will be assessed V4 28 3 days after Visit 3 - End of study Blood tests and an endothelial reactivity test will be performed and treatment compliance will be assessed
Weight waist circumference Index of Central Obesity ICO and Body Mass Index BMI Hepatic Steatosis Index HSI and Lipid Accumulation Product LAP will be measuredcalculated at each visit height at Visit 1
Heart rate and blood pressure will be measured at each visit Adverse events AEs will be collected throughout the study starting from the Informed consent signature
The study will be monitored according to the details specified in the Monitoring Plan The monitor will have the responsibility of reviewing the ongoing study with the Investigator to verify adherence to the protocol and to deal with any problems Case Report Form CRF will be checked for completeness and consistency with the source data and special attention will be dedicated to patient enrolment obtaining signed informed consent occurrence of AEs product accountability and accurate recording of variables The confidentiality of study related documents shall be maintained at all times The Investigator agrees to allow access to all study materials needed for the proper review of study conduct
An independent quality auditinspection at the study site may take place at any time during or after the study The independent auditinspection can be carried out by the Sponsors independent Quality Assurance QA by a Health Authorities or an Ethics Committee EC
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