Red Yeast Rice and Phytosterols In Statin Intolerance

Sponsor

Chestnut Hill Health System (Other)

Overall Status

Completed

CT.gov ID

NCT00897975

Collaborator

(none)

200

Enrollment

Locations

Arms

Duration (Months)

100

Patients Per Site

4.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Hyperlipidemia	Dietary Supplement: red yeast rice Drug: phytosterol Behavioral: therapeutic lifestyle program Drug: placebo	Phase 2/Phase 3

Detailed Description

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

200 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Red Yeast Rice and Phytosterols Versus Red Yeast Rice and Placebo for the Treatment of Hyperlipidemia in Patients With Statin Intolerance: A Multi-Center Randomized Double-blind Study

Study Start Date :

Jul 1, 2009

Actual Primary Completion Date :

Nov 1, 2010

Actual Study Completion Date :

Jul 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: red yeast rice (RYR) plus phytosterol arm will take red yeast rice and phytosterol supplement	Dietary Supplement: red yeast rice 600 mg 3 capsules bid Drug: phytosterol phytosterol 450 mg 2 tabs bid with food
Placebo Comparator: red yeast rice plus placebo	Dietary Supplement: red yeast rice 600 mg 3 capsules bid Drug: placebo placebo
Active Comparator: TLC plus red yeast rice plus placebo subjects attend 12 week therapeutic lifestyle program and take above supplement	Dietary Supplement: red yeast rice 600 mg 3 capsules bid Behavioral: therapeutic lifestyle program TLC - 12 weeks Drug: placebo placebo
Experimental: TLC plus RYR plus phytosterol Therapeutic lifestyle program for 12 weeks plus red yeast rice plus phytosterol	Dietary Supplement: red yeast rice 600 mg 3 capsules bid Drug: phytosterol phytosterol 450 mg 2 tabs bid with food Behavioral: therapeutic lifestyle program TLC - 12 weeks

Outcome Measures

Primary Outcome Measures

LDL cholesterol levels [one year]

Secondary Outcome Measures

myalgia compared to prior statin usage [one year]
other lipoprotein levels [one year]
weight loss in TLC program vs. baseline [one year]

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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