Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| University Hospital, Antwerp | OTHER |
Not provided
Not provided
Not provided
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
Participants will be stratified by sex before randomization to one of the two treatments for 8 weeks:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cholesfytol NG | Experimental | 3 capsules daily (orally) with dinner containing in total 1000 mg of Amla dry extract, 100 mg of Walnut leaf dry extract, 67.2 mg of Red yeast rice powder (equivalent to 2.9 mg of monacolines), 50 mg of olive fruit dry extract (equivalent to 10 mg of hydroxytyrosol). Taken for 8 weeks |
|
| Placebo | Placebo Comparator | 3 capsules daily (orally) with dinner taken for 8 weeks. Placebo contains magensium stearate, microcrystalline cellulose, colloidal silica and talc |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cholesfytol NG | Dietary Supplement | 3 capsules a day with dinner. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline LDL cholesterol at 8 weeks | Calculated from Total Cholesterol, HDL Cholesterol and Triglycerides | Baseline, 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of side effects (+ their burden) as reported in the final questionnaire | Unvalidated but standardized questionnaire on typical statin-related side effects | 8 weeks |
| Change from baseline Blood Pressure, Systolic at 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline glucose level at 8 weeks | Measurement in Fluoride Plasma | Baseline, 8 weeks |
| Change from baseline HbA1c level at 8 weeks | Measurement in EDTA Whole Blood |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Johan Bosmans, Prof. MD. | University Hospital, Antwerp | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UAntwerp, NatuRAPT | Wilrijk | Antwerp | 2610 | Belgium |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo |
| Other |
3 capsules a day with dinner |
|
average of 3 measurements during 15 minutes
| Baseline, 8 weeks |
| Change from baseline Blood Pressure, diastolic at 8 weeks | average of 3 measurements during 15 minutes | Baseline, 8 weeks |
| Change from baseline total cholesterol level at 8 weeks | Measurement in Serum | Baseline, 8 weeks |
| Change from baseline HDL cholesterol level at 8 weeks | Measurement in Serum | Baseline, 8 weeks |
| Change from baseline non-HDL cholesterol level at 8 weeks | Calculated from HDL and total cholesterol | Baseline, 8 weeks |
| Change from baseline Remnant Cholesterol at 8 weeks | Calculated from total, HDL and LDL cholesterol | Baseline, 8 weeks |
| Change from baseline triglycerides level at 8 weeks | Measurement in Serum | Baseline, 8 weeks |
| Change from baseline Apo A1 level at 8 weeks | Measurement in Serum | Baseline, 8 weeks |
| Change from baseline Apo B level at 8 weeks | Measurement in Serum | Baseline, 8 weeks |
| Change from baseline lipoprotein A (LP(a)) level at 8 weeks | Measurement in Serum | Baseline, 8 weeks |
| Change from baseline OxLDL level at 8 weeks | Measurement with ELISA | Baseline, 8 weeks |
| Change from baseline malondialdehyde (MDA) level at 8 weeks | Measurement with ELISA | Baseline, 8 weeks |
| Change from baseline glutathion (GSH) level at 8 weeks | Measurement with in house HPLC method | Baseline, 8 weeks |
| Baseline, 8 weeks |
| Change from baseline insuline level at 8 weeks | Required to correctly interpret glucose levels, Measurement in Serum | Baseline, 8 weeks |
| Change from baseline Body Mass Index (BMI) at 8 weeks | Weight and height will be combined to report BMI in kg/m^2 | Baseline, 8 weeks |
| Change from baseline waist circumference at 8 weeks | Measurement with measuring tape | Baseline, 8 weeks |
| Change from baseline hemoglobine level at 8 weeks | Required to correctly interpret HbAc1 levels, Measurement in EDTA Whole Blood | Baseline, 8 weeks |
| Change from baseline creatinine level at 8 weeks | Required to correctly interpret HbAc1 levels, Measurement in Serum | Baseline, 8 weeks |
| Change from baseline hs-CRP level at 8 weeks | Measurement in Serum | Baseline, 8 weeks |
| Change from baseline homocysteine level at 8 weeks | Measurement in Homocysteine Serum | Baseline, 8 weeks |
| Change from baseline creatine kinase (CK) level at 8 weeks | Measurement in Serum | Baseline, 8 weeks |
| Change from baseline C-peptide level at 8 weeks | Measurement in Serum | Baseline, 8 weeks |