Ignite Creation Date:
2024-05-06 @ 8:19 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06333158
Status:
RECRUITING
Last Update Posted:
2024-03-27
First Post:
2024-03-20
Brief Title:
Extracts of Amla Walnut Leaf Red Yeast Rice and Olive in Cardiovascular Prevention
Sponsor:
Nina Hermans
Organization:
Universiteit Antwerpen
Study Overview
Official Title:
Extracts of Amla Walnut Leaf Red Yeast Rice and Olive in Cardiovascular Prevention Efficacy and Tolerability of a Commercially Available Standardized Combination Preparation Cholesfytol NG as Compared to Placebo in Patients With Hypercholesterolemia a RDBPC Trial
Status:
RECRUITING
Status Verified Date:
2024-03
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:
AmWaRO
Brief Summary:
The aim of this study is to evaluate whether the use of a commercially available standardized combination preparation Cholesfytol NG containing extracts of amla walnut leaf red yeast rice and olive in individuals with hypercholesterolemia
1 Leads to a clinically relevant reduction of cholesterol levels especially LDL
2 Leads to a clinically relevant reduction of blood pressure on the short term
3 Leads to a change in oxidative stress biomarkers
Participants will be stratified by sex before randomization to one of the two treatments for 8 weeks
Cholesfytol NG 500 mg Amla dry extract 50 mg Walnut leaf dry extract 336 mg Red yeast rice powder equivalent to 145 mg monacolins 25 mg Olive dry extract equivalent to 5 mg of hydroxytyrosol per day
Placebo All treatments have an identical shape and color and should be used in the same way oral intake 3 capsulesday during dinner No dietary instructions are given and participants are asked not to change their dietary habits not to start other therapies medication supplements slimming diets extra physical activity etc during their study period Standardized questionnaires are used to obtain information on demographics dietary habits and side effects At baseline and after 8 weeks 27 ml blood is drawn for various biological analyses and blood pressure BMI and waist circumference are measured
1 Leads to a clinically relevant reduction of cholesterol levels especially LDL
2 Leads to a clinically relevant reduction of blood pressure on the short term
3 Leads to a change in oxidative stress biomarkers
Participants will be stratified by sex before randomization to one of the two treatments for 8 weeks
Cholesfytol NG 500 mg Amla dry extract 50 mg Walnut leaf dry extract 336 mg Red yeast rice powder equivalent to 145 mg monacolins 25 mg Olive dry extract equivalent to 5 mg of hydroxytyrosol per day
Placebo All treatments have an identical shape and color and should be used in the same way oral intake 3 capsulesday during dinner No dietary instructions are given and participants are asked not to change their dietary habits not to start other therapies medication supplements slimming diets extra physical activity etc during their study period Standardized questionnaires are used to obtain information on demographics dietary habits and side effects At baseline and after 8 weeks 27 ml blood is drawn for various biological analyses and blood pressure BMI and waist circumference are measured
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