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

Not Applicable

Recruiting

• Conditions: Hypercholesterolemia and Hyperlipidemia; Supplementation

• Registration Number: NCT06810466
• Lead Sponsor: IBSA Farmaceutici Italia Srl

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-12-17
• Status Verified: 2025-01
• Study First Submitted: 2025-01-08
• Study First Submitted QC: 2025-01-30
• Last Update Submitted: 2025-01-30
• Study First Posted: 2025-02-05
• Last Update Posted: 2025-02-05
• Primary Completion: 2026-01
• Study Completion: 2026-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 99

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Low-Density Lipoprotein Cholesterol (LDL-C) Serum Concentration After Target Product A Treatment	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 Outcome Measures

Name	Time	Method
Low-Density Lipoprotein Cholesterol (LDL-C) Serum Concentration After Treatment with Target Product B	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)
Serum Total Cholesterol Concentration (TC)	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).
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).
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).
High-Density Lipoprotein Cholesterol (HDL-C)	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).
Non High-Density Lipoprotein Cholesterol (Non-HDL-C)	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).
Triglycerides (TG)	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).
Apolipoprotein B	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).
Systolic Blood Pressure	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).
Diastolic Blood Pressure	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).
Mean Arterial Pressure	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).
Pulse Pressure	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).
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 percentage change (%) Weight at 8 weeks (T1) and 16 weeks (T2), compared to baseline (T0), within and between groups.
Body Mass Index (BMI)	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.
Glutamic Oxaloacetic Transaminase (GOT)	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).
Gamma-Glutamyl Transferase (Gamma - GT)	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).
Glutamic Pyruvate Transaminase (GPT)	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).
Serum Uric Acid	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).
Creatinine Concentration	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).
Creatine phosphokinase (CPK) Concentration	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.
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 percentage change (%) in Fasting Blood Glucose concentration 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.
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.
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

Trial Locations

Locations (1)

S. Orsola-Malpighi University Hospital; 🇮🇹 Bologna, Italy