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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
Sponsor:
Information provided by (Responsible Party):
Veronique Verhoeven, Universiteit Antwerpen

Study Description
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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.

Condition or disease Intervention/treatment Phase
Hypercholesterolaemia Dietary Supplement: commercially available nutrition supplement Dietary Supplement: placebo Phase 4

Study Design
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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

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Arms and Interventions
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Arm Intervention/treatment
Experimental: commercially available nutrition supplement
this group receives a commercially available nutritional supplement for a period of 2 months
 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
 Dietary Supplement: placebo


Outcome Measures
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Primary Outcome Measures :
  1. LDL level [ Time Frame: 2 months ]
  2. total cholesterol level [ Time Frame: 2 months ]
  3. triglyceride level [ Time Frame: 2 months ]
  4. HDL level [ Time Frame: 2 months ]

Secondary Outcome Measures :
  1. OxLDL [ Time Frame: 2 months ]
  2. BMI [ Time Frame: 2 months ]
  3. malondialdehyde (MDA) [ Time Frame: 2 months ]
  4. 8-OH-deoxyguanosine (8-OHdG) [ Time Frame: 2 months ]
  5. side effects [ Time Frame: 2 months ]
  6. waist circumference [ Time Frame: 2 months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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Belgium
University of Antwerp
Antwerp, Belgie, Belgium, 2610
Sponsors and Collaborators
Universiteit Antwerpen
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Veronique Verhoeven, Professor, Universiteit Antwerpen
ClinicalTrials.gov Identifier: NCT02065180     History of Changes
Other Study ID Numbers: verhoevenhermans
First Posted: February 17, 2014    Key Record Dates
Last Update Posted: May 20, 2014
Last Verified: May 2014
Additional relevant MeSH terms:
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Hypercholesterolemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases