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| Name | Class |
|---|---|
| KU Leuven | OTHER |
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Nutraceutical lipid-lowering interventions are becoming increasingly popular, particularly among patients who are intolerant or refractory to prescription statins, or who desire alternative non-conventional pharmacological treatment to manage their dyslipidaemia, whether they previously experienced statin intolerance or not. A growing body of preclinical and clinical evidence suggest that the amla (Emblica officinalis) red yeast rice (RYR), olive and walnut leaf extracts posses consideable hpolipidaemic pharmacological effects.
The present exploratory study aimed to assess the safety, efficacy, and patient's satisfaction of a combined supplementation of amla, red yeast rice, olive, and walnut leaf extracts (Cholesfytol NGĀ®) on total cholesterol (TC), low-density lipoprotein - cholesterol (LDL-C), high-density lipoprotein - cholesterol (HDL-C), non-high-density lipoprotein - cholesterol (non-HDL-C), remnant cholesterol (RC) and triglycerides (TG) in hyperlipidaemic patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cholesfytol NGĀ®) supplement | Experimental | Patients will receive a single oral dose of 2 tablets a day of Cholesfytol NGĀ®) supplement for 2-months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cholesfytol NGĀ®) supplement | Dietary Supplement | General Practitioner (GP) prescribed oral Cholesfytol NGĀ®) supplement |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in blood lipid profile | Decrease in blood total cholesterol (TC) concentration | 2-months |
| Change in blood lipid profile | Decrease in blood low-density lipoprotein - cholesterol (LDL-C) concentration | 2-months |
| Change in blood lipid profile | Decrease in blood triglycerides (TG) concentration | 2-months |
| Change in blood lipid profile | Decrease in blood non-high density lipoprotein - cholesterol (non-HDL-C) concentration | 2-months |
| Decrease in blood lipid profile | Change in blood remnant cholesterol (RC) concentration | 2-months |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of side effects | Number of patients reporting myalgia | 2-months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cliniques universitaires St-Luc and Institut de Recherche ExpƩrimentale et Clinique (IREC), KU Leuven | Leuven | Belgium |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38089061 | Derived | Hermans MP, Dierckxsens Y, Janssens I, Seidel L, Albert A, Ahn SA, Rousseau MF, Khan A. The antihyperlipidemic effect of a combined supplement of standardized dry extracts of amla (Emblica officinalis), walnut (Juglans regia), olive (Olea europaea) and red yeast rice (Monascus purpureus) powder: Reduction in circulatory low-density lipoprotein-cholesterol (LDL-C) and remnant cholesterol (RC) levels in patients with hypercholesterolemia. Front Pharmacol. 2023 Nov 27;14:1280234. doi: 10.3389/fphar.2023.1280234. eCollection 2023. |
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Cholesfytol NGĀ®) supplement treatment
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| ID | Term |
|---|---|
| D006949 | Hyperlipidemias |
| ID | Term |
|---|---|
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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