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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02065180

Enrollment

Registered

2014-02-17

Start date

2014-02-28

Completion date

2014-05-31

Last updated

2014-05-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypercholesterolaemia

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.

Interventions

DIETARY_SUPPLEMENTcommercially available nutrition supplement

the food supplement contains red rice yeast and olive extract

DIETARY_SUPPLEMENTplacebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
LDL level	2 months
total cholesterol level	2 months
triglyceride level	2 months
HDL level	2 months

Secondary

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

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 18, 2026