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

The Effect of a Red Rice and Olive Extract Nutrition Supplement on Cholesterol

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.

Study Overview

• Status: Completed
• Conditions: Hypercholesterolaemia
• Intervention / Treatment: Dietary supplement: placebo; Dietary supplement: commercially available nutrition supplement

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Phase 4

Contacts and Locations

Study Locations

• Belgium
  • Belgie
    • Antwerp, Belgie, Belgium, 2610
      • University of Antwerp

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
LDL level	2 months
total cholesterol level	2 months
triglyceride level	2 months
HDL level	2 months

Secondary Outcome Measures

Outcome Measure	Time Frame
OxLDL	2 months
BMI	2 months
malondialdehyde (MDA)	2 months
8-OH-deoxyguanosine (8-OHdG)	2 months
side effects	2 months
waist circumference	2 months

Collaborators and Investigators

• Sponsor: Universiteit Antwerpen

Publications and helpful links

General 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-PLA2, 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.

Study record dates

Study Major Dates

• Study Start: February 1, 2014
• Primary Completion (Actual): May 1, 2014
• Study Completion (Actual): May 1, 2014

Study Registration Dates

• First Submitted: February 13, 2014
• First Submitted That Met QC Criteria: February 14, 2014
• First Posted (Estimate): February 17, 2014

Study Record Updates

• Last Update Posted (Estimate): May 20, 2014
• Last Update Submitted That Met QC Criteria: May 19, 2014
• Last Verified: May 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Lipid Metabolism Disorders; Hyperlipidemias; Dyslipidemias; Hypercholesterolemia
• Other Study ID Numbers: verhoevenhermans