Hypercholesterolemia and Hyperlipidemia, Supplementation
Conditions
Keywords
mild hypercholesterolemia, supplement, lipid profile, dietary supplement
Brief summary
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.
Interventions
DIETARY_SUPPLEMENTTest Product A
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.
DIETARY_SUPPLEMENTTest Product B
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.
DIETARY_SUPPLEMENTPlacebo
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.
Sponsors
Informapro Srl
IBSA Farmaceutici Italia Srl
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Subject)
Intervention model description
Single-blind, parallel-group, randomized, placebo-controlled clinical trial, followed by an open label phase
Eligibility
Sex/Gender
ALL
Age
18 Years to 69 Years
Healthy volunteers
No
Inclusion criteria
* Prevention of cardiovascular disease * Low cardiovascular risk (\< 5%) * 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 * Signature of informed consent.
Exclusion criteria
* Patients with cardiovascular disease (in secondary prevention) or at risk of cardiovascular disease after 10 years (cardiovascular risk \>/= 5) * diabetes mellitus * Taking hypolipemiants, supplements or drugs that may involve lipid metabolism * Hypertension treatment not stabilized for at least 3 months * History of ongoing kidney, thyroid, gastrointestinal, muscle or liver disease * Any medical-surgical treatment that may limit adherence to the study protocol * Pregnant and/or breastfeeding women
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Low-Density Lipoprotein Cholesterol (LDL-C) Serum Concentration After Target Product A Treatment | At baseline (T0) and at 8 weeks. | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Low-Density Lipoprotein Cholesterol (LDL-C) | At baseline (T0), 8 weeks (T1), and 16 weeks (T2) | 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). |
| Low-Density Lipoprotein Cholesterol (LDL-C) Serum Concentration After Treatment with Target Product B | At baseline (T0) and at 8 weeks. | 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). |
| Serum Total Cholesterol Concentration (TC) | At baseline (T0), 8 weeks (T1), and 16 weeks (T2) | 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). |
| Patients' adherence to diet | Baseline (T0), 8 weeks (T1), 16 weeks (T2) | 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. |
| High-Density Lipoprotein Cholesterol (HDL-C) | At baseline (T0), 8 weeks (T1), and 16 weeks (T2) | 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). |
| Non High-Density Lipoprotein Cholesterol (Non-HDL-C) | At baseline (T0), 8 weeks (T1), and 16 weeks (T2) | 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). |
| Triglycerides (TG) | At baseline (T0), 8 weeks (T1), and 16 weeks (T2) | 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). |
| Apolipoprotein B | At baseline (T0), 8 weeks (T1), and 16 weeks (T2) | 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) |
| Systolic Blood Pressure | At baseline (T0), 8 weeks (T1), and 16 weeks (T2) | 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). |
| Diastolic Blood Pressure | At baseline (T0), 8 weeks (T1), and 16 weeks (T2) | 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). |
| Mean Arterial Pressure | At baseline (T0), 8 weeks (T1), and 16 weeks (T2) | 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). |
| Pulse Pressure | At baseline (T0), 8 weeks (T1), and 16 weeks (T2) | 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). |
| Flow-Mediated Dilation (FMD) - Endothelial Function | At baseline (T0), 8 weeks (T1), and 16 weeks (T2) | 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) |
| Body Weight | At baseline (T0), 8 weeks (T1), and 16 weeks (T2) | 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. |
| Low-Density Lipoprotein Cholesterol (LDL-C) Serum Concentration | At baseline (T0), 8 weeks (T1), and 16 weeks (T2) | 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). |
| Glutamic Oxaloacetic Transaminase (GOT) | At baseline (T0), 8 weeks (T1), and 16 weeks (T2) | 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). |
| Gamma-Glutamyl Transferase (Gamma - GT) | At baseline (T0), 8 weeks (T1), and 16 weeks (T2) | 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). |
| Glutamic Pyruvate Transaminase (GPT) | At baseline (T0), 8 weeks (T1), and 16 weeks (T2) | 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). |
| Serum Uric Acid | At baseline (T0), 8 weeks (T1), and 16 weeks (T2) | 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). |
| Creatinine Concentration | At Baseline (T0), at 8 weeks (T1), and at 16 weeks (T2). | 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). |
| Creatine phosphokinase (CPK) Concentration | At baseline (T0), 8 weeks (T1), and 16 weeks (T2) | 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. |
| Number of subjects with LDL-C normal concentration | At baseline (T0), 8 weeks (T1), and 16 weeks (T2) | 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. |
| Fasting Blood Glucose Concentration | At baseline (T0), 8 weeks (T1), and 16 weeks (T2) | 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). |
| Cardiovascular Risk (CV) | At baseline (T0), 8 weeks (T1), and 16 weeks (T2) | Assessment of the Cardiovascular Risk (CV), based on Cardiovascular Risk Chart, at 8 weeks (T1) and 16 weeks (T2), compared with baseline (T0). |
| Patients' compliance with the treatment | At baseline (T0), 8 weeks (T1), and 16 weeks (T2) | 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. |
| Patients' Tolerability of the assigned treatment | At 8 weeks (T1) and at 16 weeks (T2) | 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. |
| Patient acceptability of the assigned treatment | At 8 weeks (T1) and at 16 weeks (T2) | 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. |
| Implementation of patients' lifestyle | At Baseline (T0), at 8 weeks (T1), and at 16 weeks (T2) | 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 |
| Monitoring of adverse events | Through study completion, an average of 1 year | Collection of adverse events after treatment with product A, B and placebo |
| Body Mass Index (BMI) | At baseline (T0), 8 weeks (T1), and 16 weeks (T2) | 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. |
Countries
Italy
Contacts
Primary ContactArrigo Francesco Giuseppe Cicero, Prof.
Outcome results
None listed