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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dietary supplement | Active Comparator |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dietary supplement formulated with components of natural origin: artichoke, danshen, bergamot, folic acid, chromium and excipients. | 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]. |
| Measure | Description | Time Frame |
|---|---|---|
| Effect of the dietary supplement on LDL-C at 6-week follow-up | The primary objective is to compare the effect on LDL-C after 6 weeks of treatment with a combined food supplement compared to placebo (standard diet only). | 6 weeks |
| Effect of the dietary supplement on LDL-C at 6-week follow-up | The primary objective is to compare the effect on LDL-C after 12 weeks of treatment with a combined food supplement compared to placebo (standard diet only). | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Effect of the dietary supplement on lipid fractions | Evaluate the effect of the tested combined food supplement intake on changes in other lipid fractions | 12 weeks |
| Effect of the dietary supplement on apolipoproteins |
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Inclusion Criteria:
The subjects will have to meet all the following inclusion criteria:
Exclusion Criteria:
Subjects fulfilling one or more of the following exclusion criteria will not be included in the study:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Bologna | Bologna | BO | 40138 | Italy |
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|
| Placebo | Other | Placebo |
|
Evaluate the effect of the tested combined food supplement intake on changes in apolipoproteins
| 12 weeks |
| Effect of the dietary supplement on hsCRP | Evaluate the effect of the tested combined food supplement intake on hsCRP levels | 12 weeks |
| Effect of the dietary supplement on indexes of NAFLD | Evaluate the effect of the tested combined food supplement intake on validated indexes of non-alcoholic fatty liver disease | 12 weeks |
| Effect of the dietary supplement on waist circumference | Evaluate the effect of the tested food supplement intake on changes in waist circumference. Waist circumference will be measured in a horizontal plane at the end of a normal expiration, at the midpoint between the inferior margin of the last rib and the superior iliac crest. | 12 weeks |
| Effect of the dietary supplement on weight | Evaluate the effect of the tested food supplement intake on changes in weight. Weight will be measured to the nearest 0.1 Kg. | 12 weeks |
| Effect of the dietary supplement on blood pressure | Evaluate the effect of the tested food supplement intake on changes in systolic blood pressure and diastolic blood pressure | 12 weeks |
| Effect of the dietary supplement on creatininemia | Evaluate the effect of the tested food supplement intake on changes in creatininemia | 12 weeks |
| Effect of the dietary supplement on eGFR | Evaluate the effect of the tested food supplement intake on renal function, evaluated as eGFR | 12 weeks |
| Effect of the dietary supplement on CPK levels | Evaluate the effect of the tested food supplement intake on changes in the blood levels of CPK | 12 weeks |
| Tolerability of the dietary supplement | Comparative evaluation of the short-term tolerability of the tested food supplement. Tolerability will be evaluated through a continuous monitoring during the study, to detect any adverse event, clinical safety, laboratory findings, vital sign measurements, and physical examinations | 12 weeks |
| Acceptability of the dietary supplement | Comparative evaluation of the short-term acceptability of the tested food. Acceptability will be evaluated by the use of a 10-point hedonic scale, where 1 = Disliked extremely and 9 = Liked extremely. | 12 weeks |
| ID | Term |
|---|---|
| D006937 | Hypercholesterolemia |
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D006949 | Hyperlipidemias |
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C028972 | dan-shen root extract |
| D005492 | Folic Acid |
| D002857 | Chromium |
| D005079 | Excipients |
| ID | Term |
|---|---|
| D011622 | Pterins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D019216 | Metals, Heavy |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D028561 | Transition Elements |
| D008670 | Metals |
| D014677 | Pharmaceutical Vehicles |
| D010592 | Pharmaceutic Aids |
| D004364 | Pharmaceutical Preparations |
| D020313 | Specialty Uses of Chemicals |
| D020164 | Chemical Actions and Uses |
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