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History of Changes for Study: NCT02065180
The Effect of a Red Rice and Olive Extract Nutrition Supplement on Cholesterol Levels in Patients With Metabolic Syndrome
Latest version (submitted May 19, 2014) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 February 14, 2014 None (earliest Version on record)
2 May 19, 2014 Recruitment Status, Study Status, Contacts/Locations and Study Design
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Study NCT02065180
Submitted Date:  February 14, 2014 (v1)

Open or close this module Study Identification
Unique Protocol ID: verhoevenhermans
Brief Title: The Effect of a Red Rice and Olive Extract Nutrition Supplement on Cholesterol Levels in Patients With Metabolic Syndrome
Official Title: The Effect of a Red Rice and Olive Extract Nutrition Supplement on Cholesterol
Secondary IDs:
Open or close this module Study Status
Record Verification: February 2014
Overall Status: Recruiting
Study Start: February 2014
Primary Completion: March 2014 [Anticipated]
Study Completion: May 2014 [Anticipated]
First Submitted: February 13, 2014
First Submitted that
Met QC Criteria:
February 14, 2014
First Posted: February 17, 2014 [Estimate]
Last Update Submitted that
Met QC Criteria:
February 14, 2014
Last Update Posted: February 17, 2014 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: Universiteit Antwerpen
Responsible Party: Principal Investigator
Investigator: Veronique Verhoeven
Official Title: Professor
Affiliation: Universiteit Antwerpen
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: No
Open or close this module Study Description
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:
Open or close this module Conditions
Conditions: Hypercholesterolaemia
Keywords:
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 4
Interventional Study Model: Parallel Assignment
Number of Arms: 2
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Allocation: Randomized
Enrollment: 50 [Anticipated]
Open or close this module Arms and Interventions
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
Open or close this module Outcome Measures
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 ]

Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
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
Open or close this module Contacts/Locations
Central Contact Person: veronique verhoeven, professor
Telephone: 0032 3 265 25 29
Email: veronique.verhoeven@uantwerpen.be
Central Contact Backup: nina hermans, professor
Telephone: 0032 3 265 27 32
Email: nina.hermans@uantwerpen.be
Locations: Belgium, Belgie
University of Antwerp
[Recruiting]
Antwerp, Belgie, Belgium, 2610
Contact:Contact: veronique verhoeven, professor 32479872272 veronique.verhoeven@uantwerpen.be
Contact:Principal Investigator: veronique verhoeven, professor
Contact:Sub-Investigator: nina hermans, professor
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Links:
Available IPD/Information:

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