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| ID | Type | Description | Link |
|---|---|---|---|
| COLE_TRIAL_2023 | Other Identifier | IBSA Farmaceutici Italia Srl |
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| Name | Class |
|---|---|
| Informapro Srl | OTHER |
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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.
The 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:
Group A: Test Product A (study product) Group B: Test Product B (comparative product) Placebo group: placebo
The following visits are scheduled during the study:
T-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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test Product A | Experimental | Innovative formulation of dietary supplement |
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| Test Product B | Active Comparator | Classic formulation of dietary supplement |
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| Placebo | Placebo Comparator | Placebo |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Test Product A | Dietary Supplement | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Low-Density Lipoprotein Cholesterol (LDL-C) Serum Concentration After Target Product A Treatment | 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). | At baseline (T0) and at 8 weeks. |
| Low-Density Lipoprotein Cholesterol (LDL-C) Serum Concentration After Target Product A Treatment | 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). | At baseline (T0) and at 8 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Low-Density Lipoprotein Cholesterol (LDL-C) Serum Concentration After Treatment with Target Product B | 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). | At baseline (T0) and at 8 weeks. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Arrigo Francesco Giuseppe Cicero, Prof. | Contact | +39 512142224 | arrigo.cicero@unibo.it |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| S. Orsola-Malpighi University Hospital | Recruiting | Bologna | Italy | 40138 | Italy |
Results, data, workflows, and tools may be made available through publication, presentations at scientific meetings.
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| ID | Term |
|---|---|
| D006937 | Hypercholesterolemia |
| D006949 | Hyperlipidemias |
| ID | Term |
|---|---|
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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Single-blind, parallel-group, randomized, placebo-controlled clinical trial, followed by an open label phase
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| Test Product B | Dietary Supplement | 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. |
|
| Placebo | Dietary Supplement | Placebo does not contain functional components and is indistinguishable from Product Test B. After the fist 8 weeks, this arm will continue with the intake of the Product Test A for other 8 weeks. |
|
| Low-Density Lipoprotein Cholesterol (LDL-C) Serum Concentration After Treatment with Target Product B |
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) |
| At baseline (T0), and at 8 weeks (T1) |
| Serum Total Cholesterol Concentration (TC) | 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). | At baseline (T0), 8 weeks (T1), and 16 weeks (T2) |
| Serum Total Cholesterol Concentration (TC) | 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). | At baseline (T0), 8 weeks (T1), and 16 weeks (T2) |
| Low-Density Lipoprotein Cholesterol (LDL-C) Serum Concentration | 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). | At baseline (T0), 8 weeks (T1), and 16 weeks (T2) |
| Low-Density Lipoprotein Cholesterol (LDL-C) | 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). | At baseline (T0), 8 weeks (T1), and 16 weeks (T2) |
| High-Density Lipoprotein Cholesterol (HDL-C) | 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). | At baseline (T0), 8 weeks (T1), and 16 weeks (T2) |
| High-Density Lipoprotein Cholesterol (HDL-C) | 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). | At baseline (T0), 8 weeks (T1), and 16 weeks (T2) |
| Non High-Density Lipoprotein Cholesterol (Non-HDL-C) | 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). | At baseline (T0), 8 weeks (T1), and 16 weeks (T2) |
| Non High-Density Lipoprotein Cholesterol (Non-HDL-C) | 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). | At baseline (T0), 8 weeks (T1), and 16 weeks (T2) |
| Triglycerides (TG) | 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). | At baseline (T0), 8 weeks (T1), and 16 weeks (T2) |
| Triglycerides (TG) | 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). | At baseline (T0), 8 weeks (T1), and 16 weeks (T2) |
| Apolipoprotein B | 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) | At baseline (T0), 8 weeks (T1), and 16 weeks (T2) |
| Apolipoprotein B | 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). | At baseline (T0), 8 weeks (T1), and 16 weeks (T2) |
| Systolic Blood Pressure | 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). | At baseline (T0), 8 weeks (T1), and 16 weeks (T2) |
| Systolic Blood Pressure | 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). | At baseline (T0), 8 weeks (T1), and 16 weeks (T2) |
| Diastolic Blood Pressure | 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). | At baseline (T0), 8 weeks (T1), and 16 weeks (T2) |
| Diastolic Blood Pressure | 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). | At baseline (T0), 8 weeks (T1), and 16 weeks (T2) |
| Mean Arterial Pressure | 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). | At baseline (T0), 8 weeks (T1), and 16 weeks (T2) |
| Mean Arterial Pressure | 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). | At baseline (T0), 8 weeks (T1), and 16 weeks (T2) |
| Pulse Pressure | 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). | At baseline (T0), 8 weeks (T1), and 16 weeks (T2) |
| Pulse Pressure | Evaluation of the percentage change (%) in Pulse Pressure at 8 weeks (T1) and 16 weeks (T2), within and between groups, compared to baseline (T0). | At baseline (T0), 8 weeks (T1), and 16 weeks (T2) |
| Flow-Mediated Dilation (FMD) - Endothelial Function | 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) | At baseline (T0), 8 weeks (T1), and 16 weeks (T2) |
| Body Weight | 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. | At baseline (T0), 8 weeks (T1), and 16 weeks (T2) |
| Body Weight | Evaluation of the percentage change (%) Weight at 8 weeks (T1) and 16 weeks (T2), compared to baseline (T0), within and between groups. | At baseline (T0), 8 weeks (T1), and 16 weeks (T2) |
| Body Mass Index (BMI) | 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. | At baseline (T0), 8 weeks (T1), and 16 weeks (T2) |
| Body Mass Index (BMI) | 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. | At baseline (T0), 8 weeks (T1), and 16 weeks (T2) |
| Glutamic Oxaloacetic Transaminase (GOT) | 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). | At baseline (T0), 8 weeks (T1), and 16 weeks (T2) |
| Glutamic Oxaloacetic Transaminase (GOT) | 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). | At baseline (T0), 8 weeks (T1), and 16 weeks (T2) |
| Gamma-Glutamyl Transferase (Gamma - GT) | 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). | At baseline (T0), 8 weeks (T1), and 16 weeks (T2) |
| Gamma-Glutamyl Transferase (Gamma - GT) | 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). | At baseline (T0), 8 weeks (T1), and 16 weeks (T2) |
| Glutamic Pyruvate Transaminase (GPT) | 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). | At baseline (T0), 8 weeks (T1), and 16 weeks (T2) |
| Glutamic Pyruvate Transaminase (GPT) | 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). | At baseline (T0), 8 weeks (T1), and 16 weeks (T2) |
| Serum Uric Acid | 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). | At baseline (T0), 8 weeks (T1), and 16 weeks (T2) |
| Serum Uric Acid | 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). | At Baseline (T0), at 8 weeks (T1), and at 16 weeks (T2) |
| Creatinine Concentration | 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). | At Baseline (T0), at 8 weeks (T1), and at 16 weeks (T2). |
| Creatinine Concentration | Evaluation of the percentage change (%) in Creatinine Concentration at 8 weeks (T1) and 16 weeks (T2), within and between groups, compared to baseline (T0). | At baseline (T0), 8 weeks (T1) and 16 weeks (T2). |
| Creatine phosphokinase (CPK) Concentration | 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. | At baseline (T0), 8 weeks (T1), and 16 weeks (T2) |
| Creatine phosphokinase (CPK) Concentration | 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. | At baseline (T0), 8 weeks (T1), and 16 weeks (T2) |
| Number of subjects with LDL-C normal concentration | 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. | At baseline (T0), 8 weeks (T1), and 16 weeks (T2) |
| Fasting Blood Glucose Concentration | 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). | At baseline (T0), 8 weeks (T1), and 16 weeks (T2) |
| Fasting Blood Glucose Concentration | 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). | At baseline (T0), 8 weeks (T1), and 16 weeks (T2) |
| Cardiovascular Risk (CV) | Assessment of the Cardiovascular Risk (CV), based on Cardiovascular Risk Chart, at 8 weeks (T1) and 16 weeks (T2), compared with baseline (T0). | At baseline (T0), 8 weeks (T1), and 16 weeks (T2) |
| Patients' compliance with the treatment | 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). Number of patients: 99; assigned treatment: Test Product A; Test product B; Placebo. | At baseline (T0), 8 weeks (T1), and 16 weeks (T2) |
| Patients' Tolerability of the assigned treatment | 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. Number of patients: 99; assigned treatments: Test Product A, Test Product B, Placebo. | At 8 weeks (T1) and at 16 weeks (T2) |
| Patient acceptability of the assigned treatment | 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. Number of patients: 99; assigned treatments: Test Product A, Test Product B, Placebo. | At 8 weeks (T1) and at 16 weeks (T2) |
| Patients' adherence to diet | 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. | Baseline (T0), 8 weeks (T1), 16 weeks (T2) |
| Implementation of patients' lifestyle | 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 | At Baseline (T0), at 8 weeks (T1), and at 16 weeks (T2) |
| Monitoring of adverse events | Collection of adverse events after treatment with product A, B and placebo | Through study completion, an average of 1 year |