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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

Tracking Information
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
 (submitted: February 14, 2014)
  • 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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 14, 2014)
  • 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 ]
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
Condition  ICMJE Hypercholesterolaemia
Intervention  ICMJE
  • Dietary Supplement: commercially available nutrition supplement
    the food supplement contains red rice yeast and olive extract
  • Dietary Supplement: placebo
Study Arms  ICMJE
  • Experimental: commercially available nutrition supplement
    this group receives a commercially available nutritional supplement for a period of 2 months
    Intervention: Dietary Supplement: commercially available nutrition supplement
  • Placebo Comparator: control group
    this group receives a placebo for a period of 2 months
    Intervention: Dietary Supplement: placebo
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 14, 2014)
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:

  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
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