Ignite Creation Date:
2025-12-24 @ 4:02 PM
Ignite Modification Date:
2026-01-04 @ 9:30 AM
Study NCT ID:
NCT06810466
Status:
RECRUITING
Last Update Posted:
2025-02-05
First Post:
2025-01-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of the Effects of Two Dietary Supplement Formulations on the Lipid Profile in Mild Hypercholesterolemia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006937', 'term': 'Hypercholesterolemia'}, {'id': 'D006949', 'term': 'Hyperlipidemias'}], 'ancestors': [{'id': 'D050171', 'term': 'Dyslipidemias'}, {'id': 'D052439', 'term': 'Lipid Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Single-blind, parallel-group, randomized, placebo-controlled clinical trial, followed by an open label phase'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 99}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-12-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2026-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-30', 'studyFirstSubmitDate': '2025-01-08', 'studyFirstSubmitQcDate': '2025-01-30', 'lastUpdatePostDateStruct': {'date': '2025-02-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-02-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Low-Density Lipoprotein Cholesterol (LDL-C) Serum Concentration After Target Product A Treatment', 'timeFrame': 'At baseline (T0) and at 8 weeks.', 'description': 'Evaluation of absolute value change in Low-Density Lipoprotein Cholesterol (LDL-C) serum concentration (expressed as mg/dL), at 8 weeks (T1) of dietary supplementation with Test Product A vs baseline (T0).'}, {'measure': 'Low-Density Lipoprotein Cholesterol (LDL-C) Serum Concentration After Target Product A Treatment', 'timeFrame': 'At baseline (T0) and at 8 weeks.', 'description': 'Evaluation of the percentage variation (%) in Low-Density Lipoprotein Cholesterol (LDL-C) serum concentration at 8 weeks (T1) of dietary supplementation with Test Product A, compared to baseline (T0).'}], 'secondaryOutcomes': [{'measure': 'Low-Density Lipoprotein Cholesterol (LDL-C) Serum Concentration After Treatment with Target Product B', 'timeFrame': 'At baseline (T0) and at 8 weeks.', 'description': 'Evaluation of absolute value change in Low-Density Lipoprotein Cholesterol (LDL-C) serum concentration (expressed as mg/dL), at 8 weeks (T1) of dietary supplementation with Test Product B vs baseline (T0).'}, {'measure': 'Low-Density Lipoprotein Cholesterol (LDL-C) Serum Concentration After Treatment with Target Product B', 'timeFrame': 'At baseline (T0), and at 8 weeks (T1)', 'description': 'Evaluation of the percentage change (%) in Low-Density Lipoprotein Cholesterol (LDL-C) serum concentration at 8 weeks (T1) of dietary supplementation with Test Product B, compared to baseline (T0)'}, {'measure': 'Serum Total Cholesterol Concentration (TC)', 'timeFrame': 'At baseline (T0), 8 weeks (T1), and 16 weeks (T2)', 'description': 'Evaluation of the absolute value change in Serum Total Cholesterol concentration (TC; expressed as mg/dL) at 8 weeks (T1) and 16 weeks (T2), within and between groups, compared to baseline (T0).'}, {'measure': 'Serum Total Cholesterol Concentration (TC)', 'timeFrame': 'At baseline (T0), 8 weeks (T1), and 16 weeks (T2)', 'description': 'Evaluation of the percentage change (%) in Serum Total Cholesterol concentration (TC) at 8 weeks (T1) and 16 weeks (T2), within and between groups, compared to baseline (T0).'}, {'measure': 'Low-Density Lipoprotein Cholesterol (LDL-C) Serum Concentration', 'timeFrame': 'At baseline (T0), 8 weeks (T1), and 16 weeks (T2)', 'description': 'Evaluation of the absolute value change in serum concentrations of Low-Density Lipoprotein Cholesterol (LDL-C; expressed as mg/dL) at 8 weeks (T1) and 16 weeks (T2), within and between groups, compared to baseline (T0).'}, {'measure': 'Low-Density Lipoprotein Cholesterol (LDL-C)', 'timeFrame': 'At baseline (T0), 8 weeks (T1), and 16 weeks (T2)', 'description': 'Evaluation of the percentage change (%) in Low-Density Lipoprotein Cholesterol (LDL-C) at 8 weeks (T1) and 16 weeks (T2), within and between groups, compared to baseline (T0).'}, {'measure': 'High-Density Lipoprotein Cholesterol (HDL-C)', 'timeFrame': 'At baseline (T0), 8 weeks (T1), and 16 weeks (T2)', 'description': 'Evaluation of the absolute value change in serum concentrations of High-Density Lipoprotein Cholesterol (HDL-C; expressed as mg/dL) at 8 weeks (T1) and 16 weeks (T2), within and between groups, compared to baseline (T0).'}, {'measure': 'High-Density Lipoprotein Cholesterol (HDL-C)', 'timeFrame': 'At baseline (T0), 8 weeks (T1), and 16 weeks (T2)', 'description': 'Evaluation of the percentage change (%) in serum concentrations of High-Density Lipoprotein Cholesterol (HDL-C) at 8 weeks (T1) and 16 weeks (T2), within and between groups, compared to baseline (T0).'}, {'measure': 'Non High-Density Lipoprotein Cholesterol (Non-HDL-C)', 'timeFrame': 'At baseline (T0), 8 weeks (T1), and 16 weeks (T2)', 'description': 'Evaluation of the absolute value change in serum concentrations of Non High-Density Lipoprotein Cholesterol (Non-HDL-C; expressed in mg/dL) at 8 weeks (T1) and 16 weeks (T2), within and between groups, compared to baseline (T0).'}, {'measure': 'Non High-Density Lipoprotein Cholesterol (Non-HDL-C)', 'timeFrame': 'At baseline (T0), 8 weeks (T1), and 16 weeks (T2)', 'description': 'Evaluation of the percentage change (%) in serum concentrations of Non High-Density Lipoprotein Cholesterol (Non-HDL-C) at 8 weeks (T1) and 16 weeks (T2), within and between groups, compared to baseline (T0).'}, {'measure': 'Triglycerides (TG)', 'timeFrame': 'At baseline (T0), 8 weeks (T1), and 16 weeks (T2)', 'description': 'Evaluation of absolute value change in Triglycerides (TG) serum concentration (expressed as mg/dL), at 8 weeks (T1) and 16 weeks (T2), within and between groups, compared to baseline (T0).'}, {'measure': 'Triglycerides (TG)', 'timeFrame': 'At baseline (T0), 8 weeks (T1), and 16 weeks (T2)', 'description': 'Evaluation of the percentage change (%) in serum concentrations of Triglycerides (TG) at 8 weeks (T1) and 16 weeks (T2), within and between groups, compared to baseline (T0).'}, {'measure': 'Apolipoprotein B', 'timeFrame': 'At baseline (T0), 8 weeks (T1), and 16 weeks (T2)', 'description': 'Evaluation of the absolute value change in serum concentrations of Apolipoprotein B (expressed as mg/dL) at 8 weeks (T1) and 16 weeks (T2), within and between groups, compared to baseline (T0)'}, {'measure': 'Apolipoprotein B', 'timeFrame': 'At baseline (T0), 8 weeks (T1), and 16 weeks (T2)', 'description': 'Evaluation of the percentage change (%) in serum concentrations of Apolipoprotein B at 8 weeks (T1) and 16 weeks (T2), within and between groups, compared to baseline (T0).'}, {'measure': 'Systolic Blood Pressure', 'timeFrame': 'At baseline (T0), 8 weeks (T1), and 16 weeks (T2)', 'description': 'Evaluation of the absolute value change in Systolic Blood Pressure (expressed as mmHg) at 8 weeks (T1) and 16 weeks (T2), within and between groups, compared to baseline (T0).'}, {'measure': 'Systolic Blood Pressure', 'timeFrame': 'At baseline (T0), 8 weeks (T1), and 16 weeks (T2)', 'description': 'Evaluation of the percentage change (%) in Systolic Blood Pressure at 8 weeks (T1) and 16 weeks (T2), within and between groups, compared to baseline (T0).'}, {'measure': 'Diastolic Blood Pressure', 'timeFrame': 'At baseline (T0), 8 weeks (T1), and 16 weeks (T2)', 'description': 'Evaluation of the absolute value change in Diastolic Blood Pressure (expressed as mmHg) at 8 weeks (T1) and 16 weeks (T2), within and between groups, compared to baseline (T0).'}, {'measure': 'Diastolic Blood Pressure', 'timeFrame': 'At baseline (T0), 8 weeks (T1), and 16 weeks (T2)', 'description': 'Evaluation of the percentage change (%) in Diastolic Blood Pressure at 8 weeks (T1) and 16 weeks (T2), within and between groups, compared to baseline (T0).'}, {'measure': 'Mean Arterial Pressure', 'timeFrame': 'At baseline (T0), 8 weeks (T1), and 16 weeks (T2)', 'description': 'Evaluation of the absolute change in Mean Arterial Pressure (expressed in mmHg) at 8 weeks (T1) and 16 weeks (T2), within and between groups, compared to baseline (T0).'}, {'measure': 'Mean Arterial Pressure', 'timeFrame': 'At baseline (T0), 8 weeks (T1), and 16 weeks (T2)', 'description': 'Evaluation of the percentage change (%) in Mean Arterial Pressure at 8 weeks (T1) and 16 weeks (T2), within and between groups, compared to baseline (T0).'}, {'measure': 'Pulse Pressure', 'timeFrame': 'At baseline (T0), 8 weeks (T1), and 16 weeks (T2)', 'description': 'Evaluation of the absolute change in Pulse Pressure (expressed in mmHg) at 8 weeks (T1) and 16 weeks (T2), within and between groups, compared to baseline (T0).'}, {'measure': 'Pulse Pressure', 'timeFrame': 'At baseline (T0), 8 weeks (T1), and 16 weeks (T2)', 'description': 'Evaluation of the percentage change (%) in Pulse Pressure at 8 weeks (T1) and 16 weeks (T2), within and between groups, compared to baseline (T0).'}, {'measure': 'Flow-Mediated Dilation (FMD) - Endothelial Function', 'timeFrame': 'At baseline (T0), 8 weeks (T1), and 16 weeks (T2)', 'description': 'Evaluation of the percentage change (%) in Flow-Mediated Dilation (FMD), measured as the percentage increase in artery diameter during hyperemia, at 8 weeks (T1) and 16 weeks (T2), within and between groups, compared to baseline (T0)'}, {'measure': 'Body Weight', 'timeFrame': 'At baseline (T0), 8 weeks (T1), and 16 weeks (T2)', 'description': 'Evaluation of the absolute value change in Weight (kg) at 8 weeks (T1) and 16 weeks (T2), compared to baseline (T0), within and between groups.'}, {'measure': 'Body Weight', 'timeFrame': 'At baseline (T0), 8 weeks (T1), and 16 weeks (T2)', 'description': 'Evaluation of the percentage change (%) Weight at 8 weeks (T1) and 16 weeks (T2), compared to baseline (T0), within and between groups.'}, {'measure': 'Body Mass Index (BMI)', 'timeFrame': 'At baseline (T0), 8 weeks (T1), and 16 weeks (T2)', 'description': 'Evaluation of the absolute value change in Body Mass Index (BMI; kg/m²), at 8 weeks (T1) and 16 weeks (T2), compared to baseline (T0), within and between groups.'}, {'measure': 'Body Mass Index (BMI)', 'timeFrame': 'At baseline (T0), 8 weeks (T1), and 16 weeks (T2)', 'description': 'Evaluation of the percentage change (%) in Body Mass Index (BMI), at 8 weeks (T1) and 16 weeks (T2), compared to baseline (T0), within and between groups.'}, {'measure': 'Glutamic Oxaloacetic Transaminase (GOT)', 'timeFrame': 'At baseline (T0), 8 weeks (T1), and 16 weeks (T2)', 'description': 'Evaluation of the absolute value change in Glutamic Oxaloacetic Transaminase (GOT) concentration (expressed as U/L) at 8 weeks (T1) and 16 weeks (T2), within and between groups, compared to baseline (T0).'}, {'measure': 'Glutamic Oxaloacetic Transaminase (GOT)', 'timeFrame': 'At baseline (T0), 8 weeks (T1), and 16 weeks (T2)', 'description': 'Evaluation of the percentage change (%) in Glutamic Oxaloacetic Transaminase concentration (GOT; expressed as U/L) at 8 weeks (T1) and 16 weeks (T2), within and between groups, compared to baseline (T0).'}, {'measure': 'Gamma-Glutamyl Transferase (Gamma - GT)', 'timeFrame': 'At baseline (T0), 8 weeks (T1), and 16 weeks (T2)', 'description': 'Evaluation of the absolute value change in Gamma-Glutamyl Transferase (Gamma - GT) concentration (expressed as U/L) at 8 weeks (T1) and 16 weeks (T2), within and between groups, compared to baseline (T0).'}, {'measure': 'Gamma-Glutamyl Transferase (Gamma - GT)', 'timeFrame': 'At baseline (T0), 8 weeks (T1), and 16 weeks (T2)', 'description': 'Evaluation of the percentage change (%) in Gamma-Glutamyl Transferase (Gamma - GT) concentration at 8 weeks (T1) and 16 weeks (T2), within and between groups, compared to baseline (T0).'}, {'measure': 'Glutamic Pyruvate Transaminase (GPT)', 'timeFrame': 'At baseline (T0), 8 weeks (T1), and 16 weeks (T2)', 'description': 'Evaluation of the absolute value change in Glutamic Pyruvate Transaminase (GPT) concentration (expressed as U/L) at 8 weeks (T1) and 16 weeks (T2), within and between groups, compared to baseline (T0).'}, {'measure': 'Glutamic Pyruvate Transaminase (GPT)', 'timeFrame': 'At baseline (T0), 8 weeks (T1), and 16 weeks (T2)', 'description': 'Evaluation of the percentage change (%) in Glutamic Pyruvate Transaminase (GPT) concentration at 8 weeks (T1) and 16 weeks (T2), within and between groups, compared to baseline (T0).'}, {'measure': 'Serum Uric Acid', 'timeFrame': 'At baseline (T0), 8 weeks (T1), and 16 weeks (T2)', 'description': 'Evaluation of the absolute value change in Serum Uric Acid concentration (expressed as mg/dL) at 8 weeks (T1) and 16 weeks (T2), within and between groups, compared to baseline (T0).'}, {'measure': 'Serum Uric Acid', 'timeFrame': 'At Baseline (T0), at 8 weeks (T1), and at 16 weeks (T2)', 'description': 'Evaluation of the percentage change (%) in Serum Uric Acid concentrations at 8 weeks (T1) and 16 weeks (T2), within and between groups, compared to baseline (T0).'}, {'measure': 'Creatinine Concentration', 'timeFrame': 'At Baseline (T0), at 8 weeks (T1), and at 16 weeks (T2).', 'description': 'Evaluation of the absolute value change in Creatinine Concentration (expressed as mg/dL) at 8 weeks (T1) and 16 weeks (T2), within and between groups, compared to baseline (T0).'}, {'measure': 'Creatinine Concentration', 'timeFrame': 'At baseline (T0), 8 weeks (T1) and 16 weeks (T2).', 'description': 'Evaluation of the percentage change (%) in Creatinine Concentration at 8 weeks (T1) and 16 weeks (T2), within and between groups, compared to baseline (T0).'}, {'measure': 'Creatine phosphokinase (CPK) Concentration', 'timeFrame': 'At baseline (T0), 8 weeks (T1), and 16 weeks (T2)', 'description': 'Evaluation of the absolute value change in Creatine Phosphokinase (CPK) concentration (expressed in mcg/L) at 8 weeks (T1) and 16 weeks (T2), within and between groups, compared to baseline.'}, {'measure': 'Creatine phosphokinase (CPK) Concentration', 'timeFrame': 'At baseline (T0), 8 weeks (T1), and 16 weeks (T2)', 'description': 'Evaluation of the percentage change (%) in Creatine Phosphokinase (CPK) concentration at 8 weeks (T1) and 16 weeks (T2), within and between groups, compared to baseline.'}, {'measure': 'Number of subjects with LDL-C normal concentration', 'timeFrame': 'At baseline (T0), 8 weeks (T1), and 16 weeks (T2)', 'description': 'Evaluation at 8 weeks (T1) and 16 weeks (T2) of the number of subjects in each group with LDL-C levels (mg/dL) within the normal range of concentration.'}, {'measure': 'Fasting Blood Glucose Concentration', 'timeFrame': 'At baseline (T0), 8 weeks (T1), and 16 weeks (T2)', 'description': 'Evaluation of the absolute value change in Fasting Blood Glucose concentration (expressed as mg/dL) at 8 weeks (T1) and 16 weeks (T2), within and between groups, compared to baseline (T0).'}, {'measure': 'Fasting Blood Glucose Concentration', 'timeFrame': 'At baseline (T0), 8 weeks (T1), and 16 weeks (T2)', 'description': 'Evaluation of the percentage change (%) in Fasting Blood Glucose concentration at 8 weeks (T1) and 16 weeks (T2), within and between groups, compared to baseline (T0).'}, {'measure': 'Cardiovascular Risk (CV)', 'timeFrame': 'At baseline (T0), 8 weeks (T1), and 16 weeks (T2)', 'description': 'Assessment of the Cardiovascular Risk (CV), based on Cardiovascular Risk Chart, at 8 weeks (T1) and 16 weeks (T2), compared with baseline (T0).'}, {'measure': "Patients' compliance with the treatment", 'timeFrame': 'At baseline (T0), 8 weeks (T1), and 16 weeks (T2)', 'description': "Assessment of patient's compliance with the treatment by calculating the percentage ratio between the number of capsules taken and the number of capsules expected at 8 weeks (T1), and 16 weeks (T2), in each group and intergroup vs baseline (T0).\n\nNumber of patients: 99; assigned treatment: Test Product A; Test product B; Placebo."}, {'measure': "Patients' Tolerability of the assigned treatment", 'timeFrame': 'At 8 weeks (T1) and at 16 weeks (T2)', 'description': "Evaluation of Patients' Tolerability of the assigned treatment using the Visual Analogue Scale (VAS), with scores ranging from 1 to 10, where higher scores indicate greater tolerability, assessed at 8 weeks (T1) and 16 weeks (T2), with intra-group and inter-group evaluations.\n\nNumber of patients: 99; assigned treatments: Test Product A, Test Product B, Placebo."}, {'measure': 'Patient acceptability of the assigned treatment', 'timeFrame': 'At 8 weeks (T1) and at 16 weeks (T2)', 'description': 'Evaluation of patient acceptability of the assigned treatment using the Visual Analogue Scale (VAS), with scores ranging from 1 to 10, where higher scores indicate greater acceptability, assessed at 8 weeks (T1) and 16 weeks (T2), with intra-group and inter-group evaluations.\n\nNumber of patients: 99; assigned treatments: Test Product A, Test Product B, Placebo.'}, {'measure': "Patients' adherence to diet", 'timeFrame': 'Baseline (T0), 8 weeks (T1), 16 weeks (T2)', 'description': "Assessment of patients' adherence to diet based on the food history questionnaire recording at baseline (T0), 8 weeks (T1), 16 weeks (T2), and intra-group and intergroup evaluation."}, {'measure': "Implementation of patients' lifestyle", 'timeFrame': 'At Baseline (T0), at 8 weeks (T1), and at 16 weeks (T2)', 'description': "Measurement of the rate of successful implementation of patients' lifestyle changes, through the evaluation of the prescription of physical exercise (brisk walking or cycling for 20-30 minutes, 3-5 times per week) by the investigator, assessed at baseline (T0), 8 weeks (T1), and 16 weeks (T2), with both intra-group and inter-group evaluations"}, {'measure': 'Monitoring of adverse events', 'timeFrame': 'Through study completion, an average of 1 year', 'description': 'Collection of adverse events after treatment with product A, B and placebo'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['mild hypercholesterolemia', 'supplement', 'lipid profile', 'dietary supplement'], 'conditions': ['Hypercholesterolemia and Hyperlipidemia', 'Supplementation']}, 'descriptionModule': {'briefSummary': 'A single-center, randomized, parallel-group, double-blind, placebo-controlled clinical study followed by an open-label phase to evaluate the effects of a new formulation of a supplement on lipid profile in subjects with mild hypercholesterolemia who are non-responsive to the Mediterranean diet.\n\nThe study population consists of 99 subjects with mild hypercholesterolemia who are non-responsive to the Mediterranean diet. The participants will be divided into three groups:\n\nGroup A: Test Product A (study product) Group B: Test Product B (comparative product) Placebo group: placebo\n\nThe following visits are scheduled during the study:\n\nT-2 (day -35) - Screening visit, 5 weeks before T0 T-1 (day -28) - Enrollment visit, 4 weeks before T0 T0 (day 0) - Randomization visit, baseline T1 (day 56) - Interim visit, 8 weeks after T0 T2 (day 112) - Final visit, 16 weeks after T0 After the first 8 weeks of the study (double-blind), all three groups will continue with only Product A for an additional 8 weeks. This experimental design aims to highlight whether any differences between Test Product A and Test Product B observed during the first 8 weeks can be minimized when both arms receive the same treatment. Additionally, the effect of Product A will be observed at 8 and 16 weeks, thus providing efficacy data over a longer treatment period. This may also provide insights into the potential achievement of a plateau. Regarding the placebo group, it will be possible to distinguish the effect of the diet alone from the combined effect of the diet and supplementation with Test Product A.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '69 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Prevention of cardiovascular disease\n* Low cardiovascular risk (\\< 5%)\n* Sub-optimal serum levels of LDL-C (130-136 mg/dl; 3.37-4.14 mmol/l) and/or non-HDL-C (160-190 mg/dl; 4.14-4.92 mmol/l) at T-2\n* Signature of informed consent.\n\nExclusion Criteria:\n\n* Patients with cardiovascular disease (in secondary prevention) or at risk of cardiovascular disease after 10 years (cardiovascular risk \\>/= 5)\n* diabetes mellitus\n* Taking hypolipemiants, supplements or drugs that may involve lipid metabolism\n* Hypertension treatment not stabilized for at least 3 months\n* History of ongoing kidney, thyroid, gastrointestinal, muscle or liver disease\n* Any medical-surgical treatment that may limit adherence to the study protocol\n* Pregnant and/or breastfeeding women'}, 'identificationModule': {'nctId': 'NCT06810466', 'briefTitle': 'Evaluation of the Effects of Two Dietary Supplement Formulations on the Lipid Profile in Mild Hypercholesterolemia', 'organization': {'class': 'INDUSTRY', 'fullName': 'IBSA Farmaceutici Italia Srl'}, 'officialTitle': 'A Single-blind, Parallel-group, Randomized, Placebo-controlled Clinical Trial, to Evaluate the Effects of Two Different Formulations of a Dietary Supplement on the Lipid Profile in Subjects with Mild Hypercholesterolemia', 'orgStudyIdInfo': {'id': 'COLE_TRIAL_2023'}, 'secondaryIdInfos': [{'id': 'COLE_TRIAL_2023', 'type': 'OTHER', 'domain': 'IBSA Farmaceutici Italia Srl'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Test Product A', 'description': 'Innovative formulation of dietary supplement', 'interventionNames': ['Dietary Supplement: Test Product A']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Test Product B', 'description': 'Classic formulation of dietary supplement', 'interventionNames': ['Dietary Supplement: Test Product B']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo', 'interventionNames': ['Dietary Supplement: Placebo']}], 'interventions': [{'name': 'Test Product A', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Innovative formulation of a dietary supplement for mild hypercholesterolemia. Test Product A will be admistered daily for 8 weeks. After the fist 8 weeks, this arm will continue with the intake of the Product Test A for other 8 weeks.', 'armGroupLabels': ['Test Product A']}, {'name': 'Test Product B', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Classic formulation of a dietary supplement for mild hypercholesterolemia. After the fist 8 weeks, this arm will continue with the intake of the Product Test A for other 8 weeks.', 'armGroupLabels': ['Test Product B']}, {'name': 'Placebo', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Placebo does not contain functional components and is indistinguishable from Product Test B.\n\nAfter the fist 8 weeks, this arm will continue with the intake of the Product Test A for other 8 weeks.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '40138', 'city': 'Bologna', 'state': 'Italy', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Arrigo F.G. Cicero, Prof.', 'role': 'CONTACT', 'email': 'arrigo.cicero@unibo.it', 'phone': '+39 512142224'}], 'facility': 'S. Orsola-Malpighi University Hospital', 'geoPoint': {'lat': 44.49381, 'lon': 11.33875}}], 'centralContacts': [{'name': 'Arrigo Francesco Giuseppe Cicero, Prof.', 'role': 'CONTACT', 'email': 'arrigo.cicero@unibo.it', 'phone': '+39 512142224'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'Results, data, workflows, and tools may be made available through publication, presentations at scientific meetings.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'IBSA Farmaceutici Italia Srl', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Informapro Srl', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}