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This randomised controlled trial studies the effect of a commercially available nutritional supplement on cholesterol levels in people with metabolic syndrome and elevated cholesterol levels.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| commercially available nutrition supplement | Experimental | this group receives a commercially available nutritional supplement for a period of 2 months |
|
| control group | Placebo Comparator | this group receives a placebo for a period of 2 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| commercially available nutrition supplement | Dietary Supplement | the food supplement contains red rice yeast and olive extract |
|
| Measure | Description | Time Frame |
|---|---|---|
| LDL level | 2 months | |
| total cholesterol level | 2 months | |
| triglyceride level | 2 months | |
| HDL level | 2 months |
| Measure | Description | Time Frame |
|---|---|---|
| OxLDL | 2 months | |
| BMI | 2 months | |
| malondialdehyde (MDA) |
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Inclusion Criteria:
metabolic syndrome according to ATPIII criteria 3 of the following:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Antwerp | Antwerp | Belgie | 2610 | Belgium |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28673363 | Derived | Hermans N, Van der Auwera A, Breynaert A, Verlaet A, De Bruyne T, Van Gaal L, Pieters L, Verhoeven V. A red yeast rice-olive extract supplement reduces biomarkers of oxidative stress, OxLDL and Lp-PLA2, in subjects with metabolic syndrome: a randomised, double-blind, placebo-controlled trial. Trials. 2017 Jul 3;18(1):302. doi: 10.1186/s13063-017-2058-5. | |
| 25879228 |
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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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| placebo | Dietary Supplement |
|
| 2 months |
| 8-OH-deoxyguanosine (8-OHdG) | 2 months |
| side effects | 2 months |
| waist circumference | 2 months |
| Verhoeven V, Van der Auwera A, Van Gaal L, Remmen R, Apers S, Stalpaert M, Wens J, Hermans N. Can red yeast rice and olive extract improve lipid profile and cardiovascular risk in metabolic syndrome?: A double blind, placebo controlled randomized trial. BMC Complement Altern Med. 2015 Mar 10;15:52. doi: 10.1186/s12906-015-0576-9. |
| D009750 |
| Nutritional and Metabolic Diseases |