Ignite Creation Date:
2025-12-24 @ 10:47 PM
Ignite Modification Date:
2025-12-25 @ 8:17 PM
Study NCT ID:
NCT07178769
Status:
RECRUITING
Last Update Posted:
2025-09-17
First Post:
2025-09-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study To Evaluate The Efficacy And Safety Of A Nutritional Supplement Based On Bergamot, Artichoke And Other Ingredients For Reducing Cholesterol Levels In Patients With Hypercholesterolemia (Metachol+)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 207}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-04-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2026-07-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-11', 'studyFirstSubmitDate': '2025-09-11', 'studyFirstSubmitQcDate': '2025-09-11', 'lastUpdatePostDateStruct': {'date': '2025-09-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-07-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Difference in the change in LDL cholesterol after four months of treatment compared to the baseline visit between patients treated', 'timeFrame': 'four months', 'description': 'Difference in the change in LDL cholesterol after four months of treatment compared to the baseline visit between patients treated with a nutritional supplement (regardless of its dose) and patients in the control group.\n\nDifference in the change in LDL cholesterol after four months of treatment compared to the baseline visit between patients in group 1, group 2 and patients in the control group.'}, {'measure': 'Difference in the change in LDL cholesterol after fou months of treatment compared to the baseline visit between patients treated in 1, 2 and control group', 'timeFrame': 'four months', 'description': 'Difference in the change in LDL cholesterol after four months of treatment compared to the baseline visit between patients in group 1, group 2 and patients in the control group'}], 'secondaryOutcomes': [{'measure': 'change in triglycerides', 'timeFrame': '2-4 months', 'description': 'Difference in the change in triglycerides after 2 and 4 months of treatment compared to the baseline visit between patients in group 1 and patients in group 2.'}, {'measure': 'change in VLDL', 'timeFrame': '2-4 months', 'description': 'Difference in the change in VLDL after 2 and 4 months of treatment compared to the baseline visit between patients in group 1 and patients in group 2'}, {'measure': 'change in Apo A', 'timeFrame': '2-4 months', 'description': 'Difference in the change in Apo A after 2 and 4 months of treatment compared to the baseline visit between patients in group 1 and patients in group 2.'}, {'measure': 'change in Apo B', 'timeFrame': '2-4 months', 'description': 'Difference in the change in Apo B after 2 and 4 months of treatment compared to the baseline visit between patients in group 1 and patients in group 2'}, {'measure': 'change in Liposcale', 'timeFrame': '2-4 months', 'description': 'Difference in the change in Liposcale after 2 and 4 months of treatment compared to the baseline visit between patients in group 1 and patients in group 2'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cholesterolemia']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial with food supplement is to evaluate the effectiveness of a nutritional supplement based on bergamot, artichoke and other ingredients through low-density lipoprotein (LDL) values after four months of treatment compared to maintaining healthy lifestyle habits.\n\nThe secondary objectives are\n\n* Evaluate the improvement of the lipid profile compared to maintaining healthy lifestyle habits.\n* Evaluate the difference in effect between 1 tablet and 2 tablets daily in improving the lipid profile.\n* Evaluate changes in anthropometric data and vital signs.\n* Evaluate adherence to treatment\n* Evaluate the safety profile of the product\n* Evaluate satisfaction with treatment\n\nThere are three treatment arms:\n\n1. Arm 1 (Gr 1): Patients being treated with a nutritional supplement based on bergamot, artichoke and other ingredients with one capsule every night at dinner with a glass of water for four months.\n2. Arm 2 (Gr 2): Patients treated with a nutritional supplement based on bergamot, artichoke and other ingredients with two capsules every night at dinner with a glass of water for four months.\n3. Arm 3 (Control): Patients not taking METACHOL+. All patients in the study will be recommended to lead an active life and a healthy diet, providing them with instructions to follow according to their usual clinical practice.\n\nIt is expected to recruit 207 patients in total, 69 in each group/arm'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients who are willing and able to understand and sign the informed consent after the nature of the study has been fully explained to them and they have passed the inclusion/exclusion criteria.\n2. Patients aged greater than or equal to 18 years\n3. Patients with moderate or mild cardiovascular risk, who have LDL levels greater than 130 mg/dl.\n\nExclusion Criteria:\n\n1. Use of any other drug or food supplement for the treatment of hypercholesterolemia during the 30 days prior to selection.\n2. Allergy or hypersensitivity to any of the components of the study treatment.\n3. Decompensated cardiovascular disease, decompensated diabetes mellitus, decompensated HTN.\n4. Serious medical conditions such as: cancer, serious chronic illness considered incompatible with participation in the study or others that may interfere with the study.\n5. HIV-AIDS, Pregnancy or breastfeeding, occlusion of the central retinal artery (of foreseeable vascular origin), history of cardiovascular disease and familial hypercholesterolemia.\n6. Liver, kidney or muscle disorders.\n7. Psychiatric disorders or inability to sign the consent.\n8. Subjects with extreme eating habits and/or with a significant history of anorexia nervosa, bulimia and other eating disorders.'}, 'identificationModule': {'nctId': 'NCT07178769', 'acronym': 'METACHOL+', 'briefTitle': 'Study To Evaluate The Efficacy And Safety Of A Nutritional Supplement Based On Bergamot, Artichoke And Other Ingredients For Reducing Cholesterol Levels In Patients With Hypercholesterolemia (Metachol+)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Laboratoires Arkopharma'}, 'officialTitle': 'Multicenter Randomized Open-label Controlled Clinical Study to Evaluate the Efficacy and Safety of a Nutritional Supplement Based on Bergamot, Artichoke and Other Ingredients After Four Months of Treatment in Reducing Cholesterol Levels in Patients With Moderate or Mild Hypercholesterolemia', 'orgStudyIdInfo': {'id': 'METACHOL+'}, 'secondaryIdInfos': [{'id': 'METACHOL+', 'type': 'OTHER', 'domain': 'Effice spi S.L.'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm 1 (Gr 1)', 'description': 'Patients being treated with a nutritional supplement based on bergamot, artichoke and other ingredients with one capsule every night at dinner with a glass of water for four months.', 'interventionNames': ['Dietary Supplement: ARKOSTEROL']}, {'type': 'EXPERIMENTAL', 'label': 'Arm 2 (Gr 2)', 'description': 'Patients treated with a nutritional supplement based on bergamot, artichoke and other ingredients with two capsules every night at dinner with a glass of water for four months.', 'interventionNames': ['Dietary Supplement: ARKOSTEROL']}, {'type': 'NO_INTERVENTION', 'label': 'Arm 3 (Control): Patients not taking METACHOL+', 'description': 'All patients in the study will be recommended to lead an active life and a healthy diet, providing them with instructions to follow according to their usual clinical practice.'}], 'interventions': [{'name': 'ARKOSTEROL', 'type': 'DIETARY_SUPPLEMENT', 'description': 'After 2 and 4 months from the start of treatment, a follow-up will be carried out in which anthropometric data will be measured (weight, BMI, waist circumference), vital signs (blood pressure and pulse) and a sample will be taken for analysis to measure the following parameters: CT, LDL, HDL, triglycerides, VLDL, Apo A, Apo B, liver function (GOT, GPT) and kidney function (creatinine) and Liposcale ® (in case of treatment group).', 'armGroupLabels': ['Arm 1 (Gr 1)', 'Arm 2 (Gr 2)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '28009', 'city': 'Madrid', 'state': 'Madrid', 'status': 'NOT_YET_RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Gema Montemayor Galán, PhD', 'role': 'CONTACT', 'email': 'montemayorgemma@hotmail.com', 'phone': '+34646525456'}, {'name': 'Gema Montemayor Galán, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Centro de Salud Goya', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '28017', 'city': 'Madrid', 'state': 'Madrid', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Rocio Arriaza, PhD', 'role': 'CONTACT', 'email': 'rociarri@gmail.com', 'phone': '+34635564105'}, {'name': 'Javier Santa Cruz Hernández, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Centro de Salud Daroca', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '28027', 'city': 'Madrid', 'state': 'Madrid', 'status': 'NOT_YET_RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Ana Javierre Miranda, PhD', 'role': 'CONTACT', 'email': 'ajavierre@iies.es', 'phone': '629354864'}, {'name': 'Ana Javierre Miranda, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Centro de Salud Avenida de Aragón', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '28027', 'city': 'Madrid', 'state': 'Madrid', 'status': 'NOT_YET_RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Pilar Puebla Sanz, PhD', 'role': 'CONTACT', 'email': 'pilar.puebla@salud.madrid.org', 'phone': '+34629905689'}, {'name': 'Pilar Puebla Sanz, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Centro de Salud Avenida de Aragón', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '30201', 'city': 'Cartagena', 'state': 'Murcia', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Ana Cebrián Cuenca, PhD', 'role': 'CONTACT', 'email': 'anicebrian@gmail.com', 'phone': '+34686347110'}, {'name': 'Ana Cebrián Cuenca, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Centro de Salud Casco Antiguo', 'geoPoint': {'lat': 37.60197, 'lon': -0.98397}}, {'zip': '30300', 'city': 'Cartagena', 'state': 'Murcia', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Maria Jose Delgado, PhD', 'role': 'CONTACT', 'email': 'mariadelaunde@gmail.com', 'phone': '686454936'}, {'name': 'Maria Jose Delgado, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Centro de Salud Isaac Peral', 'geoPoint': {'lat': 37.60197, 'lon': -0.98397}}, {'zip': '30870', 'city': 'Mazarrón', 'state': 'Murcia', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Sara Carrasco Claros, PhD', 'role': 'CONTACT', 'email': 'saracarrascoclaros@gmail.com', 'phone': '+34968592388'}, {'name': 'Sara Carrasco Claros, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Centro de Salud de Mazarrón', 'geoPoint': {'lat': 37.5992, 'lon': -1.31493}}], 'centralContacts': [{'name': 'Lucía San Miguel Amelivia, Pharmacist', 'role': 'CONTACT', 'email': 'Lucia.SanMiguel@arkopharma.com', 'phone': '+34 616960711'}, {'name': 'Mª Victoria Lara García-Brioles, Pharmacist', 'role': 'CONTACT', 'email': 'maria-victoria.lara@arkopharma.com', 'phone': '+34 686449374'}], 'overallOfficials': [{'name': 'Guyoux Aurelie', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Arkopharma Laboratories'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Laboratoires Arkopharma', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}