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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 Universiteit Antwerpen:

Primary Outcome Measures:
  • LDL level [ Time Frame: 2 months ] [ Designated as safety issue: No ]
  • total cholesterol level [ Time Frame: 2 months ] [ Designated as safety issue: No ]
  • triglyceride level [ Time Frame: 2 months ] [ Designated as safety issue: No ]
  • HDL level [ Time Frame: 2 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • OxLDL [ Time Frame: 2 months ] [ Designated as safety issue: No ]
  • BMI [ Time Frame: 2 months ] [ Designated as safety issue: No ]
  • malondialdehyde (MDA) [ Time Frame: 2 months ] [ Designated as safety issue: No ]
  • 8-OH-deoxyguanosine (8-OHdG) [ Time Frame: 2 months ] [ Designated as safety issue: No ]
  • side effects [ Time Frame: 2 months ] [ Designated as safety issue: No ]
  • waist circumference [ Time Frame: 2 months ] [ Designated as safety issue: No ]

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
Genders Eligible for Study:   Both
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

No publications provided

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
Health Authority: Belgium: Ethics Committee

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

ClinicalTrials.gov processed this record on August 27, 2014