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The joint ESC/EAS guidelines for the management of dyslipidaemias recommend, for patients at low/moderate CV risk with raised LDL-C, a set of measures collectively defined as "lifestyle interventions", with use of drugs only if the LDL-C levels cannot be controlled with such lifestyle interventions. "Lifestyle interventions" also includes food supplements. The reason is the following: a simple "dietary advice" has been shown (Cochrane review and meta-analysis, Rees et al, 2013) to achieve a modest reduction of total-C and LDL-C. The review reports: Dietary advice reduced total serum cholesterol by 0.15 mmol/L (95% CI 0.06 to 0.23) and LDL cholesterol by 0.16 mmol/L (95% CI 0.08 to 0.24) after 3 to 24 months." An average reduction of LDL-C by 0.16 mmol/L (6.2 mg/dL) is definitely insufficient to control the level of LDL-C in those subjects. Therefore, those subjects would lose motivation to keep dieting. In this context, use of supplements would significantly amplify the result of diet.
A significant proportion of ischemic cardiovascular events are believed to be supported by the coexistence of traditional cardiovascular risk factors such as diabetes, hypertension, dyslipidemia, smoking, and others. The aggregation of these factors is accompanied by a significant increase in the risk of cardiovascular events.
Observational studies shown the existence of a relationship between cholesterolemia and coronary heart disease, clearly showing that subjects with even modestly increased total cholesterol values over time develop both fatal and non-fatal vascular events with a higher frequency compared to subjects with similar characteristics, but with lower basal values of cholesterol.
Numerous controlled intervention studies, on the other hand, have shown that there is a close correlation between cholesterol reduction and cardiovascular risk; in fact, reductions in the plasma concentration of total and 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 patients in secondary prevention.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active Comparator | Active Comparator | Dietary supplement |
|
| Placebo comparator | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dietary supplement | Dietary Supplement | Dietary supplement formulated with 400 mg Bergamot d.e. obtained from different parts of the Citrus Bergamot whole fruit (Citrus bergamia Risso et Poiteau, fructus), specifically from fresh fruits collected from November to February (Brumex TM). Oral administration: 1 tablet/day at evening meal |
| Measure | Description | Time Frame |
|---|---|---|
| LDL-cholesterolemia absolute reduction from baseline and between groups | Absolute reduction of LDL-cholesterolemia after 12 weeks of treatment | 12 weeks |
| LDL-cholesterolemia % reduction from baseline and between groups | % reduction of LDL-cholesterolemia after 12 weeks of treatment | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Absolute reduction from baseline and between groups in other lipid fractions, apolipoproteins and their ratios | Absolute reduction of serum concentrations of total cholesterol, HDL-cholesterol, apolipoprotein B, triglycerides and their ratios after 12 weeks of treatment | 12 weeks |
| % reduction from baseline and between groups in other lipid fractions, apolipoproteins and their ratios |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Claudio Borghi, MD | S. Orsola-Malpighi University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Bologna | Bologna | BO | 40138 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37312672 | Result | Pierdomenico M, Cicero AFG, Veronesi M, Fogacci F, Riccioni C, Benassi B. Effect of Citrus bergamia extract on lipid profile: A combined in vitro and human study. Phytother Res. 2023 Sep;37(9):4185-4195. doi: 10.1002/ptr.7897. Epub 2023 Jun 13. |
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| ID | Term |
|---|---|
| D006937 | Hypercholesterolemia |
| ID | Term |
|---|---|
| D006949 | Hyperlipidemias |
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
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| ID | Term |
|---|---|
| D019587 | Dietary Supplements |
| ID | Term |
|---|---|
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
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|
| Placebo | Other | Oral administration: 1 tablet/day at evening meal |
|
% reduction of of serum concentrations of total cholesterol, HDL-cholesterol, apolipoprotein B, triglycerides and their ratios after 12 weeks of treatment |
| 12 weeks |
| % reduction from baseline and between groups in anthropometric parameters | % reduction of body mass index after 12 weeks of treatment | 12 weeks |
| % reduction from baseline and between groups in blood pressure levels | % reduction of systolic and diastolic blood pressure after 12 weeks of treatment | 12 weeks |
| Absolute reduction from baseline and between groups in blood pressure levels | Absolute reduction of systolic and diastolic blood pressure after 12 weeks of treatment | 12 weeks |
| Absolute reduction from baseline and between groups in anthropometric parameters | Absolute reduction of body mass index after 12 weeks of treatment | 12 weeks |
| % reduction from baseline and between groups in creatine phosphokinase (CPK) serum levels | % reduction of creatine phosphokinase (CPK) serum levels after 12 weeks of treatment | 12 weeks |
| Absolute reduction from baseline and between groups in creatine phosphokinase (CPK) serum levels | Absolute reduction of creatine phosphokinase (CPK) serum levels after 12 weeks of treatment | 12 weeks |
| Absolute reduction from baseline and between groups in liver parameters | Absolute reduction of GOT, GPT and gamma-GT after 12 weeks of treatment | 12 weeks |
| % reduction from baseline and between groups in liver parameters | % reduction of GOT, GPT and gamma-GT after 12 weeks of treatment | 12 weeks |
| D009750 |
| Nutritional and Metabolic Diseases |