The Effect of a Red Rice and Olive Extract Nutrition Supplement on Cholesterol Levels in Patients With Metabolic Syndrome
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ClinicalTrials.gov Identifier: NCT02065180 |
Recruitment Status :
Completed
First Posted : February 17, 2014
Last Update Posted : May 20, 2014
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Hypercholesterolaemia | Dietary Supplement: commercially available nutrition supplement Dietary Supplement: placebo | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 50 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Triple (Participant, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | The Effect of a Red Rice and Olive Extract Nutrition Supplement on Cholesterol |
Study Start Date : | February 2014 |
Actual Primary Completion Date : | May 2014 |
Actual Study Completion Date : | May 2014 |

Arm | Intervention/treatment |
---|---|
Experimental: commercially available nutrition supplement
this group receives a commercially available nutritional supplement for a period of 2 months
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Dietary Supplement: commercially available nutrition supplement
the food supplement contains red rice yeast and olive extract |
Placebo Comparator: control group
this group receives a placebo for a period of 2 months
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Dietary Supplement: placebo |
- LDL level [ Time Frame: 2 months ]
- total cholesterol level [ Time Frame: 2 months ]
- triglyceride level [ Time Frame: 2 months ]
- HDL level [ Time Frame: 2 months ]
- OxLDL [ Time Frame: 2 months ]
- BMI [ Time Frame: 2 months ]
- malondialdehyde (MDA) [ Time Frame: 2 months ]
- 8-OH-deoxyguanosine (8-OHdG) [ Time Frame: 2 months ]
- side effects [ Time Frame: 2 months ]
- waist circumference [ Time Frame: 2 months ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
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metabolic syndrome according to ATPIII criteria 3 of the following:
- waist circumference >88cm (in females) or >102cm (in males)
- triglycerides >150mg/dl
- HDL <40 (50)mg/dl in males (females)
- blood pressure>130/85 or treatment for AHT
- glucose >110mg/dl
Exclusion Criteria:
- pregnancy
- treatment with cholesterol lowering drugs

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02065180
Belgium | |
University of Antwerp | |
Antwerp, Belgie, Belgium, 2610 |
Responsible Party: | Veronique Verhoeven, Professor, Universiteit Antwerpen |
ClinicalTrials.gov Identifier: | NCT02065180 |
Other Study ID Numbers: |
verhoevenhermans |
First Posted: | February 17, 2014 Key Record Dates |
Last Update Posted: | May 20, 2014 |
Last Verified: | May 2014 |
Hypercholesterolemia Hyperlipidemias Dyslipidemias Lipid Metabolism Disorders Metabolic Diseases |