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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Enrollment
99
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.
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 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.
S. Orsola-Malpighi University Hospital
Bologna, Italy, Italy
RECRUITINGLow-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).
Time frame: 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).
Time frame: At baseline (T0) and at 8 weeks.
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).
Time frame: At baseline (T0) and at 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)
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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)
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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)
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: Through study completion, an average of 1 year
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