Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06810466

Evaluation of the Effects of Two Dietary Supplement Formulations on the Lipid Profile in Mild Hypercholesterolemia

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Hypercholesterolemia and Hyperlipidemia Dyslipidemias Hypercholesterolemia Hyperlipidemias Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Supplementation

Age range

18 year–69 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

S. Orsola-Malpighi University Hospital

Bologna, Italy, 40138

Location status: Recruiting

Location contact

Arrigo F.G. Cicero, Prof.

CONTACT

[email protected]

+39 512142224

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Low-Density Lipoprotein Cholesterol (LDL-C) Serum Concentration After Target Product A Treatment

    Time frame: 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).

  2. Low-Density Lipoprotein Cholesterol (LDL-C) Serum Concentration After Target Product A Treatment

    Time frame: At baseline (T0) and at 8 weeks.

    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).

Secondary outcomes

  1. Low-Density Lipoprotein Cholesterol (LDL-C) Serum Concentration After Treatment with Target Product B

    Time frame: 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).

  2. Low-Density Lipoprotein Cholesterol (LDL-C) Serum Concentration After Treatment with Target Product B

    Time frame: At baseline (T0), and at 8 weeks (T1)

    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)

  3. Serum Total Cholesterol Concentration (TC)

    Time frame: 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).

  4. Serum Total Cholesterol Concentration (TC)

    Time frame: At baseline (T0), 8 weeks (T1), and 16 weeks (T2)

    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).

  5. Low-Density Lipoprotein Cholesterol (LDL-C) Serum Concentration

    Time frame: 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).

  6. Low-Density Lipoprotein Cholesterol (LDL-C)

    Time frame: 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).

  7. High-Density Lipoprotein Cholesterol (HDL-C)

    Time frame: 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).

  8. High-Density Lipoprotein Cholesterol (HDL-C)

    Time frame: At baseline (T0), 8 weeks (T1), and 16 weeks (T2)

    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).

  9. Non High-Density Lipoprotein Cholesterol (Non-HDL-C)

    Time frame: 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).

  10. Non High-Density Lipoprotein Cholesterol (Non-HDL-C)

    Time frame: At baseline (T0), 8 weeks (T1), and 16 weeks (T2)

    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).

  11. Triglycerides (TG)

    Time frame: 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).

  12. Triglycerides (TG)

    Time frame: At baseline (T0), 8 weeks (T1), and 16 weeks (T2)

    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).

  13. Apolipoprotein B

    Time frame: 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)

  14. Apolipoprotein B

    Time frame: At baseline (T0), 8 weeks (T1), and 16 weeks (T2)

    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).

  15. Systolic Blood Pressure

    Time frame: 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).

  16. Systolic Blood Pressure

    Time frame: At baseline (T0), 8 weeks (T1), and 16 weeks (T2)

    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).

  17. Diastolic Blood Pressure

    Time frame: 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).

  18. Diastolic Blood Pressure

    Time frame: At baseline (T0), 8 weeks (T1), and 16 weeks (T2)

    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).

  19. Mean Arterial Pressure

    Time frame: 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).

  20. Mean Arterial Pressure

    Time frame: At baseline (T0), 8 weeks (T1), and 16 weeks (T2)

    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).

  21. Pulse Pressure

    Time frame: 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).

  22. Pulse Pressure

    Time frame: At baseline (T0), 8 weeks (T1), and 16 weeks (T2)

    Evaluation of the percentage change (%) in Pulse Pressure at 8 weeks (T1) and 16 weeks (T2), within and between groups, compared to baseline (T0).

  23. Flow-Mediated Dilation (FMD) - Endothelial Function

    Time frame: 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)

  24. Body Weight

    Time frame: 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.

  25. Body Weight

    Time frame: At baseline (T0), 8 weeks (T1), and 16 weeks (T2)

    Evaluation of the percentage change (%) Weight at 8 weeks (T1) and 16 weeks (T2), compared to baseline (T0), within and between groups.

  26. Body Mass Index (BMI)

    Time frame: 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.

  27. Body Mass Index (BMI)

    Time frame: At baseline (T0), 8 weeks (T1), and 16 weeks (T2)

    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.

  28. Glutamic Oxaloacetic Transaminase (GOT)

    Time frame: 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).

  29. Glutamic Oxaloacetic Transaminase (GOT)

    Time frame: At baseline (T0), 8 weeks (T1), and 16 weeks (T2)

    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).

  30. Gamma-Glutamyl Transferase (Gamma - GT)

    Time frame: 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).

  31. Gamma-Glutamyl Transferase (Gamma - GT)

    Time frame: At baseline (T0), 8 weeks (T1), and 16 weeks (T2)

    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).

  32. Glutamic Pyruvate Transaminase (GPT)

    Time frame: 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).

  33. Glutamic Pyruvate Transaminase (GPT)

    Time frame: At baseline (T0), 8 weeks (T1), and 16 weeks (T2)

    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).

  34. Serum Uric Acid

    Time frame: 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).

  35. Serum Uric Acid

    Time frame: At Baseline (T0), at 8 weeks (T1), and at 16 weeks (T2)

    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).

  36. Creatinine Concentration

    Time frame: 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).

  37. Creatinine Concentration

    Time frame: At baseline (T0), 8 weeks (T1) and 16 weeks (T2).

    Evaluation of the percentage change (%) in Creatinine Concentration at 8 weeks (T1) and 16 weeks (T2), within and between groups, compared to baseline (T0).

  38. Creatine phosphokinase (CPK) Concentration

    Time frame: 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.

  39. Creatine phosphokinase (CPK) Concentration

    Time frame: At baseline (T0), 8 weeks (T1), and 16 weeks (T2)

    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.

  40. Number of subjects with LDL-C normal concentration

    Time frame: 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.

  41. Fasting Blood Glucose Concentration

    Time frame: 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).

  42. Fasting Blood Glucose Concentration

    Time frame: At baseline (T0), 8 weeks (T1), and 16 weeks (T2)

    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).

  43. Cardiovascular Risk (CV)

    Time frame: 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).

  44. Patients' compliance with the treatment

    Time frame: 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.

  45. Patients' Tolerability of the assigned treatment

    Time frame: 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.

  46. Patient acceptability of the assigned treatment

    Time frame: 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.

  47. Patients' adherence to diet

    Time frame: 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.

  48. Implementation of patients' lifestyle

    Time frame: 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

  49. Monitoring of adverse events

    Time frame: Through study completion, an average of 1 year

    Collection of adverse events after treatment with product A, B and placebo

Study contacts

Contact information is provided by the study sponsor or research team.

Arrigo Francesco Giuseppe Cicero, Prof.

CONTACT

[email protected]

+39 512142224

Sponsors and collaborators

Lead sponsor

IBSA Farmaceutici Italia Srl

Industry

Collaborators

  • Informapro Srl

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Feb 5, 2025
Registry last updated
Feb 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.