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, 33.6 mg Red yeast rice powder (equivalent to 1.45 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 capsules/day 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
36
3 capsules a day with dinner.
3 capsules a day with dinner
UAntwerp, NatuRAPT
Wilrijk, Antwerp, Belgium
Change from baseline LDL cholesterol at 8 weeks
Calculated from Total Cholesterol, HDL Cholesterol and Triglycerides
Time frame: Baseline, 8 weeks
Frequency of side effects (+ their burden) as reported in the final questionnaire
Unvalidated but standardized questionnaire on typical statin-related side effects
Time frame: 8 weeks
Change from baseline Blood Pressure, Systolic at 8 weeks
average of 3 measurements during 15 minutes
Time frame: Baseline, 8 weeks
Change from baseline Blood Pressure, diastolic at 8 weeks
average of 3 measurements during 15 minutes
Time frame: Baseline, 8 weeks
Change from baseline total cholesterol level at 8 weeks
Measurement in Serum
Time frame: Baseline, 8 weeks
Change from baseline HDL cholesterol level at 8 weeks
Measurement in Serum
Time frame: Baseline, 8 weeks
Change from baseline non-HDL cholesterol level at 8 weeks
Calculated from HDL and total cholesterol
Time frame: Baseline, 8 weeks
Change from baseline Remnant Cholesterol at 8 weeks
Calculated from total, HDL and LDL cholesterol
Time frame: Baseline, 8 weeks
Change from baseline triglycerides level at 8 weeks
Measurement in Serum
Time frame: Baseline, 8 weeks
Change from baseline Apo A1 level at 8 weeks
Measurement in Serum
Time frame: Baseline, 8 weeks
Change from baseline Apo B level at 8 weeks
Measurement in Serum
Time frame: Baseline, 8 weeks
Change from baseline lipoprotein A (LP(a)) level at 8 weeks
Measurement in Serum
Time frame: Baseline, 8 weeks
Change from baseline OxLDL level at 8 weeks
Measurement with ELISA
Time frame: Baseline, 8 weeks
Change from baseline malondialdehyde (MDA) level at 8 weeks
Measurement with ELISA
Time frame: Baseline, 8 weeks
Change from baseline glutathion (GSH) level at 8 weeks
Measurement with in house HPLC method
Time frame: Baseline, 8 weeks
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