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

Primary Purpose

Hypercholesterolaemia

Status
Completed
Phase
Phase 4
Locations
Belgium
Study Type
Interventional
Intervention
commercially available nutrition supplement
placebo
Sponsored by
Universiteit Antwerpen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypercholesterolaemia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of Antwerp

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

commercially available nutrition supplement

control group

Arm Description

this group receives a commercially available nutritional supplement for a period of 2 months

this group receives a placebo for a period of 2 months

Outcomes

Primary Outcome Measures

LDL level
total cholesterol level
triglyceride level
HDL level

Secondary Outcome Measures

OxLDL
BMI
malondialdehyde (MDA)
8-OH-deoxyguanosine (8-OHdG)
side effects
waist circumference

Full Information

First Posted
February 13, 2014
Last Updated
May 19, 2014
Sponsor
Universiteit Antwerpen
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1. Study Identification

Unique Protocol Identification Number
NCT02065180
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2014
Overall Recruitment Status
Completed
Study Start Date
February 2014 (undefined)
Primary Completion Date
May 2014 (Actual)
Study Completion Date
May 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universiteit Antwerpen

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypercholesterolaemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
commercially available nutrition supplement
Arm Type
Experimental
Arm Description
this group receives a commercially available nutritional supplement for a period of 2 months
Arm Title
control group
Arm Type
Placebo Comparator
Arm Description
this group receives a placebo for a period of 2 months
Intervention Type
Dietary Supplement
Intervention Name(s)
commercially available nutrition supplement
Intervention Description
the food supplement contains red rice yeast and olive extract
Intervention Type
Dietary Supplement
Intervention Name(s)
placebo
Primary Outcome Measure Information:
Title
LDL level
Time Frame
2 months
Title
total cholesterol level
Time Frame
2 months
Title
triglyceride level
Time Frame
2 months
Title
HDL level
Time Frame
2 months
Secondary Outcome Measure Information:
Title
OxLDL
Time Frame
2 months
Title
BMI
Time Frame
2 months
Title
malondialdehyde (MDA)
Time Frame
2 months
Title
8-OH-deoxyguanosine (8-OHdG)
Time Frame
2 months
Title
side effects
Time Frame
2 months
Title
waist circumference
Time Frame
2 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
University of Antwerp
City
Antwerp
State/Province
Belgie
ZIP/Postal Code
2610
Country
Belgium

12. IPD Sharing Statement

Citations:
PubMed Identifier
28673363
Citation
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.
Results Reference
derived
PubMed Identifier
25879228
Citation
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.
Results Reference
derived

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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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