Red Yeast Rice and Phytosterols In Statin Intolerance

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

PHASE2/PHASE3

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-07-31

Study Completion Date

2011-07-31

Brief Summary

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Red yeast rice may be useful to lower cholesterol, especially in a population of patients who cannot tolerate traditional therapy with statins.

The addition of an over-the-counter phytosterol to red yeast rice may offer additional lipid lowering benefits when compared to red yeast rice alone.

These supplements will be given to all participants. Up to one-half will enroll in a lifestyle intervention program called Change of Heart and will be compared to patients who do not participate in the program. The study will last one year.

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Detailed Description

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Although recent studies have shown that red yeast rice is an effective therapy in the treatment of hyperlipidemia, additional supplements may be required to lower cholesterol to levels that have been associated with decreased coronary events. Specifically a target has been to lower low-density lipoprotein-C (LDL-C) to levels below 100 mg/dl. Red yeast rice has been found to be effective in lowering cholesterol in the context of the Change of Heart Program, where participants are encouraged to make significant lifestyle changes. This has been documented in two recent trials that we have published in the past year in the Mayo Clinic Proceedings (July 2008) and The Annals of Internal Medicine (in press). Clinically, we have found it necessary to add a phytosterol supplement to red yeast rice to lower LDL-C levels below 100 mg/dl. There has been a great deal of interest in phytosterols in both the lay and medical press in the past several years. This over the counter supplement lowers cholesterol by acting in the intestine to decrease the absorption of cholesterol. As it is not absorbed, there have not been any reports of significant side effects. The purpose of this study is to examine the lipid lowering effects of red yeast rice with and without adding a phytosterol. Some participants will attend the Change of Heart Program and take these supplements. Another group of participants will take the same supplements, with their usual medical care, but not enroll in the Change of Heart Program. The study will last one year, and participants will have been intolerant of statins in the past.

Conditions

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Hyperlipidemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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red yeast rice (RYR) plus phytosterol

arm will take red yeast rice and phytosterol supplement

Group Type EXPERIMENTAL

red yeast rice

Intervention Type DIETARY_SUPPLEMENT

600 mg 3 capsules bid

phytosterol

Intervention Type DRUG

phytosterol 450 mg 2 tabs bid with food

red yeast rice plus placebo

Group Type PLACEBO_COMPARATOR

red yeast rice

Intervention Type DIETARY_SUPPLEMENT

600 mg 3 capsules bid

placebo

Intervention Type DRUG

placebo

TLC plus red yeast rice plus placebo

subjects attend 12 week therapeutic lifestyle program and take above supplement

Group Type ACTIVE_COMPARATOR

red yeast rice

Intervention Type DIETARY_SUPPLEMENT

600 mg 3 capsules bid

therapeutic lifestyle program

Intervention Type BEHAVIORAL

TLC - 12 weeks

placebo

Intervention Type DRUG

placebo

TLC plus RYR plus phytosterol

Therapeutic lifestyle program for 12 weeks plus red yeast rice plus phytosterol

Group Type EXPERIMENTAL

red yeast rice

Intervention Type DIETARY_SUPPLEMENT

600 mg 3 capsules bid

phytosterol

Intervention Type DRUG

phytosterol 450 mg 2 tabs bid with food

therapeutic lifestyle program

Intervention Type BEHAVIORAL

TLC - 12 weeks

Interventions

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red yeast rice

600 mg 3 capsules bid

Intervention Type DIETARY_SUPPLEMENT

phytosterol

phytosterol 450 mg 2 tabs bid with food

Intervention Type DRUG

therapeutic lifestyle program

TLC - 12 weeks

Intervention Type BEHAVIORAL

placebo

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Men and women age \> 21
* LDL \> 100 and physician suggestion to take statin
* Subject complains of muscle weakness or aching which he/she or his/her physician feels may be attributable to statin therapy
* Having stopped a statin drug for personal reasons and not willing to restart this medication
* Refusal to take a statin as prescribed by personal physician
* CPK \< 400
* Not taking any cholesterol lowering medication, red yeast rice extract or a phytosterol product for at least 1 month prior to initiation of trial
* Ability to exercise without physical restrictions
* Ability to attend 12 week consecutive Change of Heart lifestyle education sessions
* Liver function studies normal at baseline
* Subject willing to remain off the dietary supplement CoQ10 for duration of trial
* TSH must be normal

Exclusion Criteria

* A history of muscle damage (CPK \> 400 IU) on statin therapy
* Any active cardiac problem including chest pain, angina, shortness of breath with minimal activity, or unstable angina/acute coronary syndrome within one year
* Known intolerance to one of the study drugs
* Physical limitation preventing aerobic exercise program, such as severe arthritis, peripheral vascular disease, congestive heart failure, or symptom limiting pulmonary disease
* Uncontrolled hypertension (defined as SBP \> 180 mmHg or DBP \> 100 mmHg
* Heart attack, bypass surgery, or angioplasty/stent within 1 year of study
* Triglyceride level more than 400 mg/dl
* Underlying musculoskeletal disorder preventing muscle testing
* Taking other medicines including: cyclosporine, erythromycin or other macrolide antibiotics; fluconazole; niacin; fibrates; or \> 16 oz. of grapefruit juice daily

Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes