Evaluation of the Effect of a Food Supplementation With a Combined Food Supplement on Lipid Pattern, Indexes of NAFLD and Systemic Inflammation in Healthy Subjects With Suboptimal LDL-C Levels: a Two-arm Double-blind, Placebo-controlled, Randomized, Clinical Trial

University of Bologna1 site in 1 country90 target enrollmentMay 6, 2024

ConditionsHypercholesterolemia Inflammation

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Hypercholesterolemia
Sponsor: University of Bologna
Enrollment: 90
Locations: 1
Primary Endpoint: Effect of the dietary supplement on LDL-C at 6-week follow-up
Status: Not yet recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

May 6, 2024

End Date

October 11, 2024

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

University of Bologna

Responsible Party

Principal Investigator

Claudio Borghi

Prof. Dr.

University of Bologna

Eligibility Criteria

Inclusion Criteria

•The subjects will have to meet all the following 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 fulfilling one or more of the following exclusion criteria will not be included in the study:
•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;
•Anticoagulant therapy
•Uncontrolled hypertension (systolic blood pressure\> 190 mmHg or diastolic arterial pressure\> 100 mmHg);
•Known current thyroid, gastrointestinal or hepatobiliary diseases;
•Any medical or surgical condition that would limit the participant adhesion to the study protocol;
•Abuse of alcohol or drugs (current or previous);

Outcomes

Primary Outcomes

Effect of the dietary supplement on LDL-C at 6-week follow-up

Time Frame: 12 weeks

The primary objective is to compare the effect on LDL-C after 12 weeks of treatment with a combined food supplement compared to placebo (standard diet only).