[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"cholesterolemia\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:cholesterolemia":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,41],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100606685","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-100606685",false,"NCT07178769","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+)","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","METACHOL+","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\u002Fexclusion 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\u002Fdl.\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\u002For with a significant history of anorexia nervosa, bulimia and other eating disorders.","ALL","18 Years",{"count":20,"type":21},207,"ESTIMATED","INTERVENTIONAL",[24],"NA","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\u002Farm",[27],"Cholesterolemia","RECRUITING","2025-09-11",{"date":31,"type":32},"2025-09-17","ACTUAL",{"date":34,"type":32},"2025-04-20",{"date":36,"type":21},"2026-07-30",{"name":38,"class":39},"Laboratoires Arkopharma","INDUSTRY",7,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":4,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":48,"minAge":49,"maxAge":50,"enrollmentInfo":51,"targetDuration":4,"studyType":53,"phases":4,"briefSummary":54,"conditions":55,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":61,"startDateStruct":63,"completionDateStruct":65,"leadSponsor":67,"locationsCount":70},"100345971","metabolic-and-bone-changes-after-adjuvant-cancer-treatments-in-early-non-metastatic-breast-cancer-100345971","NCT03784651","Metabolic and Bone Changes After Adjuvant Cancer Treatments in Early Non-metastatic Breast Cancer","Metabolic and Bone Changes After Adjuvant Cancer Treatments in Early Non-metastatic Breast Cancer - a 5-year Follow-up Study.","Inclusion Criteria:\n\n* Postmenopausal\n* Breast cancer stage I-III\n* Eligible to receive (neo-)adjuvant chemotherapy\u002Fother antineoplastic treatment\n\nExclusion Criteria:\n\n* Prior malignancy\n* Metabolic disease (diabetes mellitus etc)","FEMALE","50 Years","70 Years",{"count":52,"type":21},120,"OBSERVATIONAL","Breast cancer is the most common cancer type in European women. Patients treated for early non-metastatic breast cancer comprise a growing group of survivors due to early diagnosis and improved treatment. Many of these survivors experience adverse effects such as decreased bone mineral density, derangement of metabolic markers (fat, glucose, insulin) and increased blood pressure. Increasing risk of bone fracture and cardiometabolic disease (eg. diabetes mellitus type 2).\n\nThe purpose of this study is to identify mechanisms behind cardiometabolic changes that may be connected to the (neo-)adjuvant treatment. On top of this we hope to indentify potential biological markers that can help prevent development of metabolic disease.\n\nWe will be recruiting 120 post-menopausal women age 50-70 with early breast cancer and 1-2 times a year for 5 years examine bone mineral density, body composition, glucose and fat metabolism and nerve damage. A questionnaire will be used to collect information on diet, physical activity and quality of life. Derudover anvendes spørgeskemaer til at indsamle information vedrørende. This new knowledge will help clinicians start adequate preventive measures to help patients avoid cardiometabolic disease secondary to cancer treatment.",[56,57,58,59,27],"Bone Fracture","Glucose, High Blood","Insulin Resistance","Blood Pressure, High","2021-09-14",{"date":62,"type":32},"2021-09-16",{"date":64,"type":32},"2018-12-17",{"date":66,"type":21},"2026-11",{"name":68,"class":69},"Rigshospitalet, Denmark","OTHER",1]