The Effect of a Red Rice and Olive Extract Nutrition Supplement on Cholesterol Levels in Patients With Metabolic Syndrome
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT02065180 |
Recruitment Status :
Completed
First Posted : February 17, 2014
Last Update Posted : May 20, 2014
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Sponsor:
Universiteit Antwerpen
Information provided by (Responsible Party):
Veronique Verhoeven, Universiteit Antwerpen
Tracking Information | |||
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First Submitted Date ICMJE | February 13, 2014 | ||
First Posted Date ICMJE | February 17, 2014 | ||
Last Update Posted Date | May 20, 2014 | ||
Study Start Date ICMJE | February 2014 | ||
Actual Primary Completion Date | May 2014 (Final data collection date for primary outcome measure) | ||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE | Same as current | ||
Change History | |||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||
Current Other Pre-specified Outcome Measures | Not Provided | ||
Original Other Pre-specified Outcome Measures | Not Provided | ||
Descriptive Information | |||
Brief Title ICMJE | The Effect of a Red Rice and Olive Extract Nutrition Supplement on Cholesterol Levels in Patients With Metabolic Syndrome | ||
Official Title ICMJE | The Effect of a Red Rice and Olive Extract Nutrition Supplement on Cholesterol | ||
Brief Summary | 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. | ||
Detailed Description | Not Provided | ||
Study Type ICMJE | Interventional | ||
Study Phase ICMJE | Phase 4 | ||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Triple (Participant, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
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Condition ICMJE | Hypercholesterolaemia | ||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||
Recruitment Status ICMJE | Completed | ||
Actual Enrollment ICMJE |
50 | ||
Original Estimated Enrollment ICMJE | Same as current | ||
Actual Study Completion Date ICMJE | May 2014 | ||
Actual Primary Completion Date | May 2014 (Final data collection date for primary outcome measure) | ||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||
Accepts Healthy Volunteers ICMJE | Yes | ||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||
Listed Location Countries ICMJE | Belgium | ||
Removed Location Countries | |||
Administrative Information | |||
NCT Number ICMJE | NCT02065180 | ||
Other Study ID Numbers ICMJE | verhoevenhermans | ||
Has Data Monitoring Committee | No | ||
U.S. FDA-regulated Product | Not Provided | ||
IPD Sharing Statement ICMJE | Not Provided | ||
Responsible Party | Veronique Verhoeven, Universiteit Antwerpen | ||
Study Sponsor ICMJE | Universiteit Antwerpen | ||
Collaborators ICMJE | Not Provided | ||
Investigators ICMJE | Not Provided | ||
PRS Account | Universiteit Antwerpen | ||
Verification Date | May 2014 | ||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |