protocolSection identificationModule nctId: NCT06333158, orgStudyIdInfo id: AmWaRO Study, briefTitle: Extracts of Amla, Walnut Leaf, Red Yeast Rice and Olive in Cardiovascular Prevention, acronym: AmWaRO, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2024-09, completionDateStruct date: 2024-12, studyFirstPostDateStruct date: 2024-03-27, lastUpdatePostDateStruct date: 2024-03-27, sponsorCollaboratorsModule leadSponsor name: Nina Hermans, class: OTHER, collaborators name: University Hospital, Antwerp, descriptionModule briefSummary: 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 hypercholesterolemia1. 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., conditionsModule conditions: Low-Density-Lipoprotein-Type [LDL] Hyperlipoproteinemia, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 36, type: ESTIMATED, armsInterventionsModule interventions name: Cholesfytol NG, interventions name: Placebo, outcomesModule primaryOutcomes measure: Change from baseline LDL cholesterol at 8 weeks, secondaryOutcomes measure: Frequency of side effects (+ their burden) as reported in the final questionnaire, secondaryOutcomes measure: Change from baseline Blood Pressure, Systolic at 8 weeks, secondaryOutcomes measure: Change from baseline Blood Pressure, diastolic at 8 weeks, secondaryOutcomes measure: Change from baseline total cholesterol level at 8 weeks, secondaryOutcomes measure: Change from baseline HDL cholesterol level at 8 weeks, secondaryOutcomes measure: Change from baseline non-HDL cholesterol level at 8 weeks, secondaryOutcomes measure: Change from baseline Remnant Cholesterol at 8 weeks, secondaryOutcomes measure: Change from baseline triglycerides level at 8 weeks, secondaryOutcomes measure: Change from baseline Apo A1 level at 8 weeks, secondaryOutcomes measure: Change from baseline Apo B level at 8 weeks, secondaryOutcomes measure: Change from baseline lipoprotein A (LP(a)) level at 8 weeks, secondaryOutcomes measure: Change from baseline OxLDL level at 8 weeks, secondaryOutcomes measure: Change from baseline malondialdehyde (MDA) level at 8 weeks, secondaryOutcomes measure: Change from baseline glutathion (GSH) level at 8 weeks, otherOutcomes measure: Change from baseline glucose level at 8 weeks, otherOutcomes measure: Change from baseline HbA1c level at 8 weeks, otherOutcomes measure: Change from baseline insuline level at 8 weeks, otherOutcomes measure: Change from baseline Body Mass Index (BMI) at 8 weeks, otherOutcomes measure: Change from baseline waist circumference at 8 weeks, otherOutcomes measure: Change from baseline hemoglobine level at 8 weeks, otherOutcomes measure: Change from baseline creatinine level at 8 weeks, otherOutcomes measure: Change from baseline hs-CRP level at 8 weeks, otherOutcomes measure: Change from baseline homocysteine level at 8 weeks, otherOutcomes measure: Change from baseline creatine kinase (CK) level at 8 weeks, otherOutcomes measure: Change from baseline C-peptide level at 8 weeks, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 76 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: UAntwerp, NatuRAPT, status: RECRUITING, city: Wilrijk, state: Antwerp, zip: 2610, country: Belgium, contacts name: Nina Hermans, Prof., role: CONTACT, phone: 003232652732, email: nina.hermans@uantwerpen.be, geoPoint lat: 51.16734, lon: 4.39513, hasResults: False