HyperlipidemiaPhase 2/3NCT00897975
Red Yeast Rice and Phytosterols In Statin Intolerance
A Phase 2/3 study testing red yeast rice, phytosterol and therapeutic lifestyle program in people with Hyperlipidemia, run by Chestnut Hill Health System at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hyperlipidemia
- What is being tested?
- red yeast rice, phytosterol and therapeutic lifestyle program
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 2 sitesUnited States
- Study dates
- Jul 2009to Jul 2011
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 12Show fewer
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Abington Memorial Hospital
Abington, Pennsylvania
Chestnut Hill Hospital
Philadelphia, Pennsylvania, 19118
About this study
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
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.
Read the 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.
- Conditions
- Hyperlipidemia
- Being tested
- red yeast rice, phytosterol, therapeutic lifestyle program, placebo
- Keywords
- statin associated myalgias, hyperlipidemia, red yeast rice, phytosterols, therapeutic lifestyle changes, compliance
- Medical subject headings
- Hyperlipidemias, Patient Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
red yeast riceDietary supplement
600 mg 3 capsules bid
phytosterolDrug
phytosterol 450 mg 2 tabs bid with food
therapeutic lifestyle programBehavioural
TLC - 12 weeks
placeboDrug
placebo
| Study group | Role | What they receive |
|---|---|---|
| red yeast rice (RYR) plus phytosterol | Experimental | arm will take red yeast rice and phytosterol supplement Receives: Dietary Supplement: red yeast rice; Drug: phytosterol |
| red yeast rice plus placebo | Placebo comparator | Not described Receives: 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 Receives: 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 Receives: Dietary Supplement: red yeast rice; Drug: phytosterol; Behavioral: therapeutic lifestyle program |
What is being measured
The primary outcome is the main question the study is designed to answer.
LDL cholesterol levels
Measured: one year
Secondary outcomes (3)
myalgia compared to prior statin usage
Measured: one year
other lipoprotein levels
Measured: one year
weight loss in TLC program vs. baseline
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2009 (estimated)
- Study startJul 2009
- Primary completionNov 2010
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HyperlipidemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chestnut Hill Health System
- Sponsor type
- University, hospital or other
- Investigators
- David J Becker, MD, Principal investigator, Chestnut Hill Heathcare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00897975
- Sponsor's protocol ID
- FWA00005390 Chestnut HillHC
- Status last verified
- Nov 2009
- First submitted
- 11 May 2009
- Last updated
- 18 Jul 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 23816039
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00897975
- Acronym / sponsor ID
- FWA00005390 Chestnut HillHC
- Conditions
- Hyperlipidemia
- Keywords
- statin associated myalgias, hyperlipidemia, red yeast rice, phytosterols, therapeutic lifestyle changes, compliance
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Chestnut Hill Health SystemUniversity, hospital or other
- Study start
- Jul 2009
- Primary completion
- Nov 2010 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 12 May 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| red yeast rice (RYR) plus phytosterol | Experimental | Dietary Supplement: red yeast rice, Drug: phytosterolarm will take red yeast rice and phytosterol supplement |
| red yeast rice plus placebo | Placebo comparator | Dietary Supplement: red yeast rice, Drug: placebo |
| TLC plus red yeast rice plus placebo | Active comparator | Dietary Supplement: red yeast rice, Behavioral: therapeutic lifestyle program, Drug: placebosubjects attend 12 week therapeutic lifestyle program and take above supplement |
| TLC plus RYR plus phytosterol | Experimental | Dietary Supplement: red yeast rice, Drug: phytosterol, Behavioral: therapeutic lifestyle programTherapeutic lifestyle program for 12 weeks plus red yeast rice plus phytosterol |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| red yeast rice600 mg 3 capsules bid | Dietary supplement | TLC plus RYR plus phytosterol, TLC plus red yeast rice plus placebo, red yeast rice (RYR) plus phytosterol, red yeast rice plus placebo |
| phytosterolphytosterol 450 mg 2 tabs bid with food | Drug | TLC plus RYR plus phytosterol, red yeast rice (RYR) plus phytosterol |
| therapeutic lifestyle programTLC - 12 weeks | Behavioural | TLC plus RYR plus phytosterol, TLC plus red yeast rice plus placebo |
| placeboplacebo | Drug | TLC plus red yeast rice plus placebo, red yeast rice plus placebo |
Primary outcome
LDL cholesterol levels
Time frame: one year
3 secondary outcomes
myalgia compared to prior statin usage
Time frame: one year
other lipoprotein levels
Time frame: one year
weight loss in TLC program vs. baseline
Time frame: one year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2011.
- Derived from this study: PubMed 23816039Becker 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David J Becker, MD principal investigator
Chestnut Hill Heathcare
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing red yeast rice, phytosterol and therapeutic lifestyle program in people with Hyperlipidemia, run by Chestnut Hill Health System at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
LDL cholesterol levels (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00897975, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2011.