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The Effect of a Red Rice and Olive Extract Nutrition Supplement on Cholesterol Levels in Patients With Metabolic Syndrome

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Veronique Verhoeven, Universiteit Antwerpen
ClinicalTrials.gov Identifier:
NCT02065180
First received: February 13, 2014
Last updated: May 19, 2014
Last verified: May 2014
  Purpose
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 Intervention Phase
Hypercholesterolaemia Dietary Supplement: commercially available nutrition supplement Dietary Supplement: placebo Phase 4

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Veronique Verhoeven, Universiteit Antwerpen:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 50
Study Start Date: February 2014
Study Completion Date: May 2014
Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02065180

Locations
Belgium
University of Antwerp
Antwerp, Belgie, Belgium, 2610
Sponsors and Collaborators
Universiteit Antwerpen
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Veronique Verhoeven, Professor, Universiteit Antwerpen
ClinicalTrials.gov Identifier: NCT02065180     History of Changes
Other Study ID Numbers: verhoevenhermans
Study First Received: February 13, 2014
Last Updated: May 19, 2014

Additional relevant MeSH terms:
Hypercholesterolemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on August 21, 2017