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NCT06403748

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

Sponsor: University of Bologna

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2024-05-06

Completion Date

2024-10-11

Last Updated

2024-05-08

Healthy Volunteers

Yes

Conditions

Hypercholesterolemia Inflammation

Interventions

DIETARY_SUPPLEMENT

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) \[group 2\].

OTHER

Placebo

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.

Locations (1)

University of Bologna

Bologna, BO, Italy