Ignite Creation Date:
2025-12-25 @ 12:16 AM
Ignite Modification Date:
2025-12-25 @ 10:19 PM
Study NCT ID:
NCT06333158
Status:
COMPLETED
Last Update Posted:
2024-11-14
First Post:
2024-03-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Extracts of Amla, Walnut Leaf, Red Yeast Rice and Olive in Cardiovascular Prevention
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 36}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-03-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2024-06-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-11-12', 'studyFirstSubmitDate': '2024-03-20', 'studyFirstSubmitQcDate': '2024-03-20', 'lastUpdatePostDateStruct': {'date': '2024-11-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-03-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-06-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Change from baseline glucose level at 8 weeks', 'timeFrame': 'Baseline, 8 weeks', 'description': 'Measurement in Fluoride Plasma'}, {'measure': 'Change from baseline HbA1c level at 8 weeks', 'timeFrame': 'Baseline, 8 weeks', 'description': 'Measurement in EDTA Whole Blood'}, {'measure': 'Change from baseline insuline level at 8 weeks', 'timeFrame': 'Baseline, 8 weeks', 'description': 'Required to correctly interpret glucose levels, Measurement in Serum'}, {'measure': 'Change from baseline Body Mass Index (BMI) at 8 weeks', 'timeFrame': 'Baseline, 8 weeks', 'description': 'Weight and height will be combined to report BMI in kg/m\\^2'}, {'measure': 'Change from baseline waist circumference at 8 weeks', 'timeFrame': 'Baseline, 8 weeks', 'description': 'Measurement with measuring tape'}, {'measure': 'Change from baseline hemoglobine level at 8 weeks', 'timeFrame': 'Baseline, 8 weeks', 'description': 'Required to correctly interpret HbAc1 levels, Measurement in EDTA Whole Blood'}, {'measure': 'Change from baseline creatinine level at 8 weeks', 'timeFrame': 'Baseline, 8 weeks', 'description': 'Required to correctly interpret HbAc1 levels, Measurement in Serum'}, {'measure': 'Change from baseline hs-CRP level at 8 weeks', 'timeFrame': 'Baseline, 8 weeks', 'description': 'Measurement in Serum'}, {'measure': 'Change from baseline homocysteine level at 8 weeks', 'timeFrame': 'Baseline, 8 weeks', 'description': 'Measurement in Homocysteine Serum'}, {'measure': 'Change from baseline creatine kinase (CK) level at 8 weeks', 'timeFrame': 'Baseline, 8 weeks', 'description': 'Measurement in Serum'}, {'measure': 'Change from baseline C-peptide level at 8 weeks', 'timeFrame': 'Baseline, 8 weeks', 'description': 'Measurement in Serum'}], 'primaryOutcomes': [{'measure': 'Change from baseline LDL cholesterol at 8 weeks', 'timeFrame': 'Baseline, 8 weeks', 'description': 'Calculated from Total Cholesterol, HDL Cholesterol and Triglycerides'}], 'secondaryOutcomes': [{'measure': 'Frequency of side effects (+ their burden) as reported in the final questionnaire', 'timeFrame': '8 weeks', 'description': 'Unvalidated but standardized questionnaire on typical statin-related side effects'}, {'measure': 'Change from baseline Blood Pressure, Systolic at 8 weeks', 'timeFrame': 'Baseline, 8 weeks', 'description': 'average of 3 measurements during 15 minutes'}, {'measure': 'Change from baseline Blood Pressure, diastolic at 8 weeks', 'timeFrame': 'Baseline, 8 weeks', 'description': 'average of 3 measurements during 15 minutes'}, {'measure': 'Change from baseline total cholesterol level at 8 weeks', 'timeFrame': 'Baseline, 8 weeks', 'description': 'Measurement in Serum'}, {'measure': 'Change from baseline HDL cholesterol level at 8 weeks', 'timeFrame': 'Baseline, 8 weeks', 'description': 'Measurement in Serum'}, {'measure': 'Change from baseline non-HDL cholesterol level at 8 weeks', 'timeFrame': 'Baseline, 8 weeks', 'description': 'Calculated from HDL and total cholesterol'}, {'measure': 'Change from baseline Remnant Cholesterol at 8 weeks', 'timeFrame': 'Baseline, 8 weeks', 'description': 'Calculated from total, HDL and LDL cholesterol'}, {'measure': 'Change from baseline triglycerides level at 8 weeks', 'timeFrame': 'Baseline, 8 weeks', 'description': 'Measurement in Serum'}, {'measure': 'Change from baseline Apo A1 level at 8 weeks', 'timeFrame': 'Baseline, 8 weeks', 'description': 'Measurement in Serum'}, {'measure': 'Change from baseline Apo B level at 8 weeks', 'timeFrame': 'Baseline, 8 weeks', 'description': 'Measurement in Serum'}, {'measure': 'Change from baseline lipoprotein A (LP(a)) level at 8 weeks', 'timeFrame': 'Baseline, 8 weeks', 'description': 'Measurement in Serum'}, {'measure': 'Change from baseline OxLDL level at 8 weeks', 'timeFrame': 'Baseline, 8 weeks', 'description': 'Measurement with ELISA'}, {'measure': 'Change from baseline malondialdehyde (MDA) level at 8 weeks', 'timeFrame': 'Baseline, 8 weeks', 'description': 'Measurement with ELISA'}, {'measure': 'Change from baseline glutathion (GSH) level at 8 weeks', 'timeFrame': 'Baseline, 8 weeks', 'description': 'Measurement with in house HPLC method'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Low-Density-Lipoprotein-Type [LDL] Hyperlipoproteinemia']}, '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 hypercholesterolemia\n\n1. Leads to a clinically relevant reduction of cholesterol levels, especially LDL,\n2. Leads to a clinically relevant reduction of blood pressure on the short term,\n3. Leads to a change in oxidative stress biomarkers.\n\nParticipants will be stratified by sex before randomization to one of the two treatments for 8 weeks:\n\n* 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\n* 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '76 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* LDL ≥ 130 mg/dL\n\nExclusion Criteria:\n\n* \\<18 jaar\n* \\>76 jaar\n* Smoking\n* Use of nutritional supplements or (chronic) medication\\*\n* Triglycerides \\> 400 mg/dL\n* \\> 14 alcoholic consumptions/week\n* Chronic illness (e.g. diabetes, atherosclerosis, reumatoid arthritis)\n* Acute infection\n* Current pregnancy or pregnancy wish during the study period\n* Breast feeding\n* When nutritional supplements were used regularly, participation is allowed after a 10-day wash out period. Use of medication will be individually assessed and is permitted if it does not interfere with the used treatments and the patient is stable on the medication. Use of lipid lowering medication of food supplements is only permitted after a wash out period of at least 6 weeks.'}, 'identificationModule': {'nctId': 'NCT06333158', 'acronym': 'AmWaRO', 'briefTitle': 'Extracts of Amla, Walnut Leaf, Red Yeast Rice and Olive in Cardiovascular Prevention', 'organization': {'class': 'OTHER', 'fullName': 'Universiteit Antwerpen'}, 'officialTitle': '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.', 'orgStudyIdInfo': {'id': 'AmWaRO Study'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cholesfytol NG', 'description': '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', 'interventionNames': ['Dietary Supplement: Cholesfytol NG']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': '3 capsules daily (orally) with dinner taken for 8 weeks. Placebo contains magensium stearate, microcrystalline cellulose, colloidal silica and talc', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'Cholesfytol NG', 'type': 'DIETARY_SUPPLEMENT', 'description': '3 capsules a day with dinner.', 'armGroupLabels': ['Cholesfytol NG']}, {'name': 'Placebo', 'type': 'OTHER', 'description': '3 capsules a day with dinner', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2610', 'city': 'Wilrijk', 'state': 'Antwerp', 'country': 'Belgium', 'facility': 'UAntwerp, NatuRAPT', 'geoPoint': {'lat': 51.16734, 'lon': 4.39513}}], 'overallOfficials': [{'name': 'Johan Bosmans, Prof. MD.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Antwerp'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nina Hermans', 'class': 'OTHER'}, 'collaborators': [{'name': 'University Hospital, Antwerp', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Nina Hermans', 'investigatorAffiliation': 'Universiteit Antwerpen'}}}}