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Red Yeast Rice and Phytosterols In Statin Intolerance

Primary Purpose

Hyperlipidemia

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
red yeast rice
phytosterol
therapeutic lifestyle program
placebo
Sponsored by
Chestnut Hill Health System
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hyperlipidemia focused on measuring statin associated myalgias, hyperlipidemia, red yeast rice, phytosterols, therapeutic lifestyle changes, compliance

Eligibility Criteria

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

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

Sites / Locations

  • Abington Memorial Hospital
  • Chestnut Hill Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Placebo Comparator

Active Comparator

Experimental

Arm Label

red yeast rice (RYR) plus phytosterol

red yeast rice plus placebo

TLC plus red yeast rice plus placebo

TLC plus RYR plus phytosterol

Arm Description

arm will take red yeast rice and phytosterol supplement

subjects attend 12 week therapeutic lifestyle program and take above supplement

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

Outcomes

Primary Outcome Measures

LDL cholesterol levels

Secondary Outcome Measures

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

Full Information

First Posted
May 11, 2009
Last Updated
July 14, 2011
Sponsor
Chestnut Hill Health System
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1. Study Identification

Unique Protocol Identification Number
NCT00897975
Brief Title
Red Yeast Rice and Phytosterols In Statin Intolerance
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 Type
Interventional

2. Study Status

Record Verification Date
November 2009
Overall Recruitment Status
Completed
Study Start Date
July 2009 (undefined)
Primary Completion Date
November 2010 (Actual)
Study Completion Date
July 2011 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Chestnut Hill Health System

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperlipidemia
Keywords
statin associated myalgias, hyperlipidemia, red yeast rice, phytosterols, therapeutic lifestyle changes, compliance

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
200 (Actual)

8. Arms, Groups, and Interventions

Arm Title
red yeast rice (RYR) plus phytosterol
Arm Type
Experimental
Arm Description
arm will take red yeast rice and phytosterol supplement
Arm Title
red yeast rice plus placebo
Arm Type
Placebo Comparator
Arm Title
TLC plus red yeast rice plus placebo
Arm Type
Active Comparator
Arm Description
subjects attend 12 week therapeutic lifestyle program and take above supplement
Arm Title
TLC plus RYR plus phytosterol
Arm Type
Experimental
Arm Description
Therapeutic lifestyle program for 12 weeks plus red yeast rice plus phytosterol
Intervention Type
Dietary Supplement
Intervention Name(s)
red yeast rice
Intervention Description
600 mg 3 capsules bid
Intervention Type
Drug
Intervention Name(s)
phytosterol
Intervention Description
phytosterol 450 mg 2 tabs bid with food
Intervention Type
Behavioral
Intervention Name(s)
therapeutic lifestyle program
Intervention Description
TLC - 12 weeks
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
placebo
Primary Outcome Measure Information:
Title
LDL cholesterol levels
Time Frame
one year
Secondary Outcome Measure Information:
Title
myalgia compared to prior statin usage
Time Frame
one year
Title
other lipoprotein levels
Time Frame
one year
Title
weight loss in TLC program vs. baseline
Time Frame
one year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David J Becker, MD
Organizational Affiliation
Chestnut Hill Heathcare
Official's Role
Principal Investigator
Facility Information:
Facility Name
Abington Memorial Hospital
City
Abington
State/Province
Pennsylvania
Country
United States
Facility Name
Chestnut Hill Hospital
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19118
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
23816039
Citation
Becker DJ, French B, Morris PB, Silvent E, Gordon RY. Phytosterols, red yeast rice, and lifestyle changes instead of statins: a randomized, double-blinded, placebo-controlled trial. Am Heart J. 2013 Jul;166(1):187-96. doi: 10.1016/j.ahj.2013.03.019. Epub 2013 Apr 30.
Results Reference
derived

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Red Yeast Rice and Phytosterols In Statin Intolerance

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