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

• ClinicalTrials.gov Identifier: NCT02065180
• Recruitment Status: Completed
• First Posted: February 17, 2014
• Last Update Posted: May 20, 2014
• Sponsor: Universiteit Antwerpen
• Information provided by (Responsible Party): Veronique Verhoeven, Universiteit Antwerpen

Tracking Information

• First Submitted Date: February 13, 2014
• First Posted Date: February 17, 2014
• Last Update Posted Date: May 20, 2014
• Study Start Date: February 2014
• Actual Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current

Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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
• 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: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Hypercholesterolaemia

Intervention

• Dietary Supplement: commercially available nutrition supplement
  the food supplement contains red rice yeast and olive extract
• Dietary Supplement: placebo

Study Arms

• 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 *

• Hermans N, Van der Auwera A, Breynaert A, Verlaet A, De Bruyne T, Van Gaal L, Pieters L, Verhoeven V. A red yeast rice-olive extract supplement reduces biomarkers of oxidative stress, OxLDL and Lp-PLA(2), in subjects with metabolic syndrome: a randomised, double-blind, placebo-controlled trial. Trials. 2017 Jul 3;18(1):302. doi: 10.1186/s13063-017-2058-5.
• Verhoeven V, Van der Auwera A, Van Gaal L, Remmen R, Apers S, Stalpaert M, Wens J, Hermans N. Can red yeast rice and olive extract improve lipid profile and cardiovascular risk in metabolic syndrome?: A double blind, placebo controlled randomized trial. BMC Complement Altern Med. 2015 Mar 10;15:52. doi: 10.1186/s12906-015-0576-9.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: February 14, 2014): 50
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: May 2014
• Actual Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Belgium

Administrative Information

• NCT Number: NCT02065180
• Other Study ID Numbers: verhoevenhermans
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Veronique Verhoeven, Universiteit Antwerpen
• Original Responsible Party: Same as current
• Current Study Sponsor: Universiteit Antwerpen
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Universiteit Antwerpen
• Verification Date: May 2014