Effect of a Dietary Supplement on Lipid Pattern, Indexes of NAFLD and Systemic Inflammation in Healthy Subjects With Suboptimal LDL-C Levels

University of Bologna

Status: Not yet enrolling

Conditions: Inflammation; Hypercholesterolemia

Treatments: Other: Placebo; Dietary Supplement: Dietary supplement formulated with components of natural origin: artichoke, danshen, bergamot, folic acid, chromium and excipients.

Study type: Interventional

Funder types: Other

Identifiers

NCT06403748

NUT1-BO-2022

Details and patient eligibility

About

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.

Enrollment: 90 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

The subjects will have to meet all the following inclusion criteria:

1. Subjects agree to participate in the study and having dated and signed the informed consent form.
2. Male or female aged ≥ 18 years and ≤ 70 years old.
3. LDL-Cholesterol plasma levels >115 mg/dL and < 190 mg/dL.
4. TG<400 mg/dL.
5. 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.
6. 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:

1. Subjects already affected by cardiovascular diseases (secondary prevention) or with estimated 10 years cardiovascular disease risk > 5%;
2. Obesity (BMI>30 kg/m2) or diabetes mellitus;
3. Assumption of lipid-lowering drugs or food supplements, or drugs potentially affecting the lipid metabolism;
4. Antihypertensive treatment not stabilized for at least 3 months;
5. Anticoagulant therapy
6. Uncontrolled hypertension (systolic blood pressure> 190 mmHg or diastolic arterial pressure> 100 mmHg);
7. Known current thyroid, gastrointestinal or hepatobiliary diseases;
8. Any medical or surgical condition that would limit the participant adhesion to the study protocol;
9. Abuse of alcohol or drugs (current or previous);
10. History of malignant neoplasia in the 5 years prior to enrolment in the study;
11. History or clinical evidence of inflammatory diseases such as severe arthritis, systemic lupus erythematosus or chronic inflammatory diseases or current therapy with immunosuppressive agents or long-term glucocorticoids;
12. History or clinical evidence of any significant concomitant disease that could compromise the safety of the subject or the possibility of completing the study;
13. Known previous intolerance to one component of the tested nutraceuticals or to one of these plant species: Asteraceae or Compositae;
14. Women in fertile age not using consolidated contraceptive methods
15. Pregnancy and Breastfeeding.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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90 participants in 2 patient groups, including a placebo group

Dietary supplement

Active Comparator group

Treatment:

Dietary Supplement: Dietary supplement formulated with components of natural origin: artichoke, danshen, bergamot, folic acid, chromium and excipients.

Placebo

Placebo Comparator group

Treatment:

Other: Placebo