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

NANot yet recruitingINTERVENTIONAL
Enrollment

90

Participants

Timeline

Start Date

May 6, 2024

Primary Completion Date

October 11, 2024

Study Completion Date

October 11, 2024

Conditions
HypercholesterolemiaInflammation
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

Placebo

Trial Locations (1)

40138

University of Bologna, Bologna

All Listed Sponsors
lead

University of Bologna

OTHER

NCT06403748 - Effect of a Dietary Supplement on Lipid Pattern, Indexes of NAFLD and Systemic Inflammation in Healthy Subjects With Suboptimal LDL-C Levels | Biotech Hunter | Biotech Hunter