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

NCT ID: NCT06403748

Last Updated: 2024-05-08

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-06
• Study Completion Date: 2024-10-11

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.

Conditions

Hypercholesterolemia; Inflammation

Study Design

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

Study Groups

Dietary supplement

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: DIETARY_SUPPLEMENT

The study will be conducted in male and female subjects, at least 18 and less than 70 years of age, with suboptimal level of LDL-Cholesterol (LDL 115-190 mg/dL) randomized into two groups to receive a preconstituted food supplement (NUT) combination containing (Red yeast rice 160 mg + Berberis aristate 449,7 mg + Folic acid 200 μg and others) in combination with a standard Mediterranean diet at low cholesterol content (\<200 mg/day) (Standard of Care - SOC) \[group 1\], or a PLACEBO in combination with hypo-cholesterol diet (healthy Mediterranean diet following the indication of the European Atherosclerosis Society guidelines) \[group 2\].

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Placebo

Interventions

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

The study will be conducted in male and female subjects, at least 18 and less than 70 years of age, with suboptimal level of LDL-Cholesterol (LDL 115-190 mg/dL) randomized into two groups to receive a preconstituted food supplement (NUT) combination containing (Red yeast rice 160 mg + Berberis aristate 449,7 mg + Folic acid 200 μg and others) in combination with a standard Mediterranean diet at low cholesterol content (\<200 mg/day) (Standard of Care - SOC) \[group 1\], or a PLACEBO in combination with hypo-cholesterol diet (healthy Mediterranean diet following the indication of the European Atherosclerosis Society guidelines) \[group 2\].

Intervention Type: DIETARY_SUPPLEMENT

Placebo

Placebo

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. 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

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.

• 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

Locations

University of Bologna

Bologna, BO, Italy

Countries

Italy

Facility Contacts

Claudio Borghi, MD

Role: primary

claudio.borghi@unibo.it

051 2142848 ext. +39

Arrigo F. Cicero, MD

Role: backup

arrigo.cicero@unibo.it

Other Identifiers

NUT1-BO-2022

Identifier Type: -

Identifier Source: org_study_id