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

NCT ID: NCT02065180

Last Updated: 2014-05-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-02-28

Study Completion Date

2014-05-31

Brief Summary

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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

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Conditions

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Hypercholesterolaemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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commercially available nutrition supplement

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

Group Type EXPERIMENTAL

commercially available nutrition supplement

Intervention Type DIETARY_SUPPLEMENT

the food supplement contains red rice yeast and olive extract

control group

this group receives a placebo for a period of 2 months

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DIETARY_SUPPLEMENT

Interventions

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commercially available nutrition supplement

the food supplement contains red rice yeast and olive extract

Intervention Type DIETARY_SUPPLEMENT

placebo

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Universiteit Antwerpen

OTHER

Sponsor Role lead

Responsible Party

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Veronique Verhoeven

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of Antwerp

Antwerp, Belgie, Belgium

Site Status

Countries

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Belgium

References

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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.

Reference Type DERIVED
PMID: 28673363 (View on PubMed)

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.

Reference Type DERIVED
PMID: 25879228 (View on PubMed)

Other Identifiers

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verhoevenhermans

Identifier Type: -

Identifier Source: org_study_id

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