Red Yeast Rice and Phytosterols In Statin Intolerance

NCT00897975 | Completed Phase 2 DMC

• 1 other identifier: FWA00005390 Chestnut HillHC
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 2

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.

Conditions

Hyperlipidemia

Keywords

statin associated myalgias; hyperlipidemia; red yeast rice; phytosterols; therapeutic lifestyle changes; compliance

Outcome Measures

Primary Outcomes (1)

• LDL cholesterol levels

  one year

Secondary Outcomes (3)

• myalgia compared to prior statin usage

  one year

• other lipoprotein levels

  one year

• weight loss in TLC program vs. baseline

  one year

Study Arms (4)

red yeast rice (RYR) plus phytosterol

EXPERIMENTAL

arm will take red yeast rice and phytosterol supplement

Dietary Supplement: red yeast rice; Drug: phytosterol

red yeast rice plus placebo

PLACEBO COMPARATOR

Dietary Supplement: red yeast rice; Drug: placebo

TLC plus red yeast rice plus placebo

ACTIVE COMPARATOR

subjects attend 12 week therapeutic lifestyle program and take above supplement

Dietary Supplement: red yeast rice; Behavioral: therapeutic lifestyle program; Drug: placebo

TLC plus RYR plus phytosterol

EXPERIMENTAL

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

Dietary Supplement: red yeast rice; Drug: phytosterol; Behavioral: therapeutic lifestyle program

Interventions

red yeast rice DIETARY_SUPPLEMENT

600 mg 3 capsules bid

TLC plus RYR plus phytosterol; TLC plus red yeast rice plus placebo; red yeast rice (RYR) plus phytosterol; red yeast rice plus placebo

phytosterol DRUG

phytosterol 450 mg 2 tabs bid with food

TLC plus RYR plus phytosterol; red yeast rice (RYR) plus phytosterol

therapeutic lifestyle program BEHAVIORAL

TLC - 12 weeks

TLC plus RYR plus phytosterol; TLC plus red yeast rice plus placebo

placebo DRUG

placebo

TLC plus red yeast rice plus placebo; red yeast rice plus placebo

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chestnut Hill Health System: lead

Study Sites (2)

Abington Memorial Hospital

Abington, Pennsylvania, United States

Location

Chestnut Hill Hospital

Philadelphia, Pennsylvania, 19118, United States

Location

Related Publications (1)

• 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.

  PMID: 23816039 DERIVED

MeSH Terms

Conditions

Hyperlipidemias; Patient Compliance

Interventions

red yeast rice; Phytosterols

Condition Hierarchy (Ancestors)

Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Sterols; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Membrane Lipids; Lipids; Phytochemicals; Biological Factors

Study Officials

• David J Becker, MD

  Chestnut Hill Heathcare

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 11, 2009
• First Posted: May 12, 2009
• Study Start: July 1, 2009
• Primary Completion: November 1, 2010
• Study Completion: July 1, 2011
• Last Updated: July 18, 2011

Record last verified: 2009-11

Locations

US (2)