Clinical trial NCT06810466: Evaluation of the Effects of Two Dietary Supplement Formulations on the Lipid Profile in Mild Hypercholesterolemia
Official 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hypercholesterolemia and Hyperlipidemia
Supplementation
Keywords: mild hypercholesterolemia
supplement
lipid profile
dietary supplement
Lead sponsor: IBSA Farmaceutici Italia Srl
Sponsor class: INDUSTRY
Collaborators: name: Informapro Srl
First posted: 2025-02-05
Enrollment: 99
Sex: ALL
Minimum age (years): 18
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Single-blind, parallel-group, randomized, placebo-controlled clinical trial, followed by an open label phase
Primary purpose: OTHER

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.


Eligibility criteria: 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

Primary outcomes:
measure: Low-Density Lipoprotein Cholesterol (LDL-C) Serum Concentration After Target Product A Treatment
timeFrame: At baseline (T0) and at 8 weeks.
measure: Low-Density Lipoprotein Cholesterol (LDL-C) Serum Concentration After Target Product A Treatment
timeFrame: At baseline (T0) and at 8 weeks.
Secondary outcomes:
measure: Low-Density Lipoprotein Cholesterol (LDL-C) Serum Concentration After Treatment with Target Product B
timeFrame: At baseline (T0) and at 8 weeks.
measure: Low-Density Lipoprotein Cholesterol (LDL-C) Serum Concentration After Treatment with Target Product B
timeFrame: At baseline (T0), and at 8 weeks (T1)
measure: Serum Total Cholesterol Concentration (TC)
timeFrame: At baseline (T0), 8 weeks (T1), and 16 weeks (T2)
measure: Serum Total Cholesterol Concentration (TC)
timeFrame: At baseline (T0), 8 weeks (T1), and 16 weeks (T2)
measure: Low-Density Lipoprotein Cholesterol (LDL-C) Serum Concentration
timeFrame: At baseline (T0), 8 weeks (T1), and 16 weeks (T2)
measure: Low-Density Lipoprotein Cholesterol (LDL-C)
timeFrame: At baseline (T0), 8 weeks (T1), and 16 weeks (T2)
measure: High-Density Lipoprotein Cholesterol (HDL-C)
timeFrame: At baseline (T0), 8 weeks (T1), and 16 weeks (T2)
measure: High-Density Lipoprotein Cholesterol (HDL-C)
timeFrame: At baseline (T0), 8 weeks (T1), and 16 weeks (T2)
measure: Non High-Density Lipoprotein Cholesterol (Non-HDL-C)
timeFrame: At baseline (T0), 8 weeks (T1), and 16 weeks (T2)
measure: Non High-Density Lipoprotein Cholesterol (Non-HDL-C)
timeFrame: At baseline (T0), 8 weeks (T1), and 16 weeks (T2)
measure: Triglycerides (TG)
timeFrame: At baseline (T0), 8 weeks (T1), and 16 weeks (T2)
measure: Triglycerides (TG)
timeFrame: At baseline (T0), 8 weeks (T1), and 16 weeks (T2)
measure: Apolipoprotein B
timeFrame: At baseline (T0), 8 weeks (T1), and 16 weeks (T2)
measure: Apolipoprotein B
timeFrame: At baseline (T0), 8 weeks (T1), and 16 weeks (T2)
measure: Systolic Blood Pressure
timeFrame: At baseline (T0), 8 weeks (T1), and 16 weeks (T2)
measure: Systolic Blood Pressure
timeFrame: At baseline (T0), 8 weeks (T1), and 16 weeks (T2)
measure: Diastolic Blood Pressure
timeFrame: At baseline (T0), 8 weeks (T1), and 16 weeks (T2)
measure: Diastolic Blood Pressure
timeFrame: At baseline (T0), 8 weeks (T1), and 16 weeks (T2)
measure: Mean Arterial Pressure
timeFrame: At baseline (T0), 8 weeks (T1), and 16 weeks (T2)
measure: Mean Arterial Pressure
timeFrame: At baseline (T0), 8 weeks (T1), and 16 weeks (T2)
measure: Pulse Pressure
timeFrame: At baseline (T0), 8 weeks (T1), and 16 weeks (T2)
measure: Pulse Pressure
timeFrame: At baseline (T0), 8 weeks (T1), and 16 weeks (T2)
measure: Flow-Mediated Dilation (FMD) - Endothelial Function
timeFrame: At baseline (T0), 8 weeks (T1), and 16 weeks (T2)
measure: Body Weight
timeFrame: At baseline (T0), 8 weeks (T1), and 16 weeks (T2)
measure: Body Weight
timeFrame: At baseline (T0), 8 weeks (T1), and 16 weeks (T2)
measure: Body Mass Index (BMI)
timeFrame: At baseline (T0), 8 weeks (T1), and 16 weeks (T2)
measure: Body Mass Index (BMI)
timeFrame: At baseline (T0), 8 weeks (T1), and 16 weeks (T2)
measure: Glutamic Oxaloacetic Transaminase (GOT)
timeFrame: At baseline (T0), 8 weeks (T1), and 16 weeks (T2)
measure: Glutamic Oxaloacetic Transaminase (GOT)
timeFrame: At baseline (T0), 8 weeks (T1), and 16 weeks (T2)
measure: Gamma-Glutamyl Transferase (Gamma - GT)
timeFrame: At baseline (T0), 8 weeks (T1), and 16 weeks (T2)
measure: Gamma-Glutamyl Transferase (Gamma - GT)
timeFrame: At baseline (T0), 8 weeks (T1), and 16 weeks (T2)
measure: Glutamic Pyruvate Transaminase (GPT)
timeFrame: At baseline (T0), 8 weeks (T1), and 16 weeks (T2)
measure: Glutamic Pyruvate Transaminase (GPT)
timeFrame: At baseline (T0), 8 weeks (T1), and 16 weeks (T2)
measure: Serum Uric Acid
timeFrame: At baseline (T0), 8 weeks (T1), and 16 weeks (T2)
measure: Serum Uric Acid
timeFrame: At Baseline (T0), at 8 weeks (T1), and at 16 weeks (T2)
measure: Creatinine Concentration
timeFrame: At Baseline (T0), at 8 weeks (T1), and at 16 weeks (T2).
measure: Creatinine Concentration
timeFrame: At baseline (T0), 8 weeks (T1) and 16 weeks (T2).
measure: Creatine phosphokinase (CPK) Concentration
timeFrame: At baseline (T0), 8 weeks (T1), and 16 weeks (T2)
measure: Creatine phosphokinase (CPK) Concentration
timeFrame: At baseline (T0), 8 weeks (T1), and 16 weeks (T2)
measure: Number of subjects with LDL-C normal concentration
timeFrame: At baseline (T0), 8 weeks (T1), and 16 weeks (T2)
measure: Fasting Blood Glucose Concentration
timeFrame: At baseline (T0), 8 weeks (T1), and 16 weeks (T2)
measure: Fasting Blood Glucose Concentration
timeFrame: At baseline (T0), 8 weeks (T1), and 16 weeks (T2)
measure: Cardiovascular Risk (CV)
timeFrame: At baseline (T0), 8 weeks (T1), and 16 weeks (T2)
measure: Patients' compliance with the treatment
timeFrame: At baseline (T0), 8 weeks (T1), and 16 weeks (T2)
measure: Patients' Tolerability of the assigned treatment
timeFrame: At 8 weeks (T1) and at 16 weeks (T2)
measure: Patient acceptability of the assigned treatment
timeFrame: At 8 weeks (T1) and at 16 weeks (T2)
measure: Patients' adherence to diet
timeFrame: Baseline (T0), 8 weeks (T1), 16 weeks (T2)
measure: Implementation of patients' lifestyle
timeFrame: At Baseline (T0), at 8 weeks (T1), and at 16 weeks (T2)
measure: Monitoring of adverse events
timeFrame: Through study completion, an average of 1 year
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: S. Orsola-Malpighi University Hospital
Study officials:
References: