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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

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 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
Primary Completion Date : May 2014
Study Completion Date : May 2014


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



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 ]


Information from the National Library of Medicine

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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

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