UAntwerp, NatuRAPT
Wilrijk, Antwerp, 2610, Belgium
NCT Number: NCT06333158
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.
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Notify Me18 year–76 year
All sexes
Interventional
Phase 4
Wilrijk, Antwerp, 2610, Belgium
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
3 capsules a day with dinner.
3 capsules a day with dinner
Time frame: Baseline, 8 weeks
Calculated from Total Cholesterol, HDL Cholesterol and Triglycerides
Time frame: 8 weeks
Unvalidated but standardized questionnaire on typical statin-related side effects
Time frame: Baseline, 8 weeks
average of 3 measurements during 15 minutes
Time frame: Baseline, 8 weeks
average of 3 measurements during 15 minutes
Time frame: Baseline, 8 weeks
Measurement in Serum
Time frame: Baseline, 8 weeks
Measurement in Serum
Time frame: Baseline, 8 weeks
Calculated from HDL and total cholesterol
Time frame: Baseline, 8 weeks
Calculated from total, HDL and LDL cholesterol
Time frame: Baseline, 8 weeks
Measurement in Serum
Time frame: Baseline, 8 weeks
Measurement in Serum
Time frame: Baseline, 8 weeks
Measurement in Serum
Time frame: Baseline, 8 weeks
Measurement in Serum
Time frame: Baseline, 8 weeks
Measurement with ELISA
Time frame: Baseline, 8 weeks
Measurement with ELISA
Time frame: Baseline, 8 weeks
Measurement with in house HPLC method
Time frame: Baseline, 8 weeks
Measurement in Fluoride Plasma
Time frame: Baseline, 8 weeks
Measurement in EDTA Whole Blood
Time frame: Baseline, 8 weeks
Required to correctly interpret glucose levels, Measurement in Serum
Time frame: Baseline, 8 weeks
Weight and height will be combined to report BMI in kg/m^2
Time frame: Baseline, 8 weeks
Measurement with measuring tape
Time frame: Baseline, 8 weeks
Required to correctly interpret HbAc1 levels, Measurement in EDTA Whole Blood
Time frame: Baseline, 8 weeks
Required to correctly interpret HbAc1 levels, Measurement in Serum
Time frame: Baseline, 8 weeks
Measurement in Serum
Time frame: Baseline, 8 weeks
Measurement in Homocysteine Serum
Time frame: Baseline, 8 weeks
Measurement in Serum
Time frame: Baseline, 8 weeks
Measurement in Serum
Nina Hermans
Other
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.
Acronym: AmWaRO
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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