Effect of a Dietary Supplement on Lipid Pattern, Indexes of NAFLD and Systemic Inflammation in He… (NCT06403748) | Clinical Trial Compass
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Effect of a Dietary Supplement on Lipid Pattern, Indexes of NAFLD and Systemic Inflammation in Healthy Subjects With Suboptimal LDL-C Levels
Italy90 participantsStarted 2024-05-06
Plain-language summary
The primary purpose of our research will be to evaluate if, in subjects with a low-moderate cardiovascular risk (CV risk\>1% but \< 5%) evidenced by sub-optimal cholesterol levels as per ESC/EAS guidelines (LDL cholesterol \>115 mg/dL, \< 190 mg/dL) supplementation with a food supplement is able to significantly influence plasma lipid levels. Furthermore, the systemic activation status of the inflammatory cascade and the arterial wall stiffness will be investigated.
Who can participate
Age range18 Years – 70 Years
SexALL
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Inclusion criteria
✓. Subjects agree to participate in the study and having dated and signed the informed consent form.
✓. Male or female aged ≥ 18 years and ≤ 70 years old.
✓. LDL-Cholesterol plasma levels \>115 mg/dL and \< 190 mg/dL.
✓. TG\<400 mg/dL.
✓. Subjects who, according to the SCORE charts, have a low or moderate cardiovascular risk (defined as a total cardiovascular risk \< 5%) and for whom, according to ESC/EAS guidelines 2012, the intervention strategy does not require a pharmacological lipid- lowering intervention.
✓. Subjects who have the capability to communicate, to make themselves understood, and to comply with the study's requirements.
Exclusion criteria
✕. Subjects already affected by cardiovascular diseases (secondary prevention) or with estimated 10 years cardiovascular disease risk \> 5%;
✕. Obesity (BMI\>30 kg/m2) or diabetes mellitus;
✕. Assumption of lipid-lowering drugs or food supplements, or drugs potentially affecting the lipid metabolism;
✕. Antihypertensive treatment not stabilized for at least 3 months;