Effect of a Food Supplementation With a Combined Food Supplement on Lipid Pattern, Indexes of Non-alcoholic Fatty Liver Disease and Systemic Inflammation

NCT ID: NCT06247137

Last Updated: 2024-04-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-01
• Study Completion Date: 2022-12-30

Brief Summary

Several controlled interventional studies have shown that there is a close correlation between cholesterol reduction and cardiovascular risk; in fact, reductions in serum levels of total cholesterol and low-density lipoprotein cholesterol (LDL-C), obtained through lifestyle modification or specific drugs, result in reductions in the incidence of major coronary events. The effectiveness of these interventions has been demonstrated both in subjects in primary prevention and in subjects in secondary prevention.

Based on this evidence, the National Cholesterol Education Program (NCEP) has defined in the ATP III report the target values of LDL-C to be reached with interventions on food and / or pharmacological habits to perform an effective cardiovascular prevention.

Although the atherogenic action of hypercholesterolemia is largely attributable to a direct damage exerted on vascular endothelium, recent studies suggest that the activation of a low-grade systemic pro-inflammatory state, typical of the patient with cardiovascular risk factors, does also play a role in the determinism of endothelial damage and atheroma degeneration of the arteries. It is believed that this systemic inflammation, as documented by the determination of some humoral signs of inflammation (e.g. C-reactive protein, interleukin-6, tumor necrosis factor-α), may further contribute to an increase of cardiovascular risk.

The inflammatory state can modulate the atherosclerotic process at various levels, determining endothelial activation, promoting leukocyte chemotaxis in the sub-intimal space of the arterial wall and therefore the formation of an atheromatous plaque rich in inflammatory cells; the latter represents the lesion responsible for the vast majority of the coronary and cerebrovascular events observed in subjects with cardiovascular risk factors.

Conditions

Hypercholesterolemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Dietary supplement

Group Type: ACTIVE_COMPARATOR

Dietary Supplement

Intervention Type: DIETARY_SUPPLEMENT

Dietary supplement formulated with components of natural origin: artichoke, bergamot, folic acid, astaxanthin, Chromium picolinate and excipients.

Oral administration: 1 tablet/day at evening meal

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Placebo (microcrystalline cellulose, calcium carbonate, magnesium stearate, silica dioxide and iron oxides).

Oral administration: 1 tablet/day at evening meal.

Interventions

Dietary Supplement

Dietary supplement formulated with components of natural origin: artichoke, bergamot, folic acid, astaxanthin, Chromium picolinate and excipients.

Oral administration: 1 tablet/day at evening meal

Intervention Type: DIETARY_SUPPLEMENT

Placebo

Placebo (microcrystalline cellulose, calcium carbonate, magnesium stearate, silica dioxide and iron oxides).

Oral administration: 1 tablet/day at evening meal.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Subjects agree to participate in the study and having dated and signed the informed consent form.

2. Subjects who have the capability to communicate, to make themselves understood, and to comply with the study's requirements.

3. Male or female aged ≥ 18 years and ≤ 70 years old.

4. LDL-Cholesterol blood levels >115 mg/dL and < 190 mg/dL.

5. TG<400 mg/dL.

6. 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.

7. Patient covered by the Social Security scheme.

Exclusion Criteria

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 since at least 3 months;

5. Anticoagulants 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 patient 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 disease 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

14. Women in fertile age not using consolidated contraceptive methods

15. Pregnancy and Breastfeeding.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Bologna

OTHER

Sponsor Role: lead

Responsible Party

Claudio Borghi

Prof. Dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Claudio Borghi, MD

Role: PRINCIPAL_INVESTIGATOR

University of Bologna

Locations

University of Bologna

Bologna, BO, Italy

Countries

Italy

Other Identifiers

NUT1-BO-2021

Identifier Type: -

Identifier Source: org_study_id