HyperlipidemiaNCT00114855
The Effect of Hypocol® on Lipids in Subjects With Mild Hypercholesterolemia and Mildly Elevated Blood Glucose
A study testing HYPOCOL® in people with Hyperlipidemia and Glucose Metabolism Disorders, run by Oslo University Hospital at 1 site in Norway.
Trial summary
The purpose of this study is to determine to what degree Hypocol® (Red Yeast Rice) may lower low density lipoprotein (LDL)-cholesterol in a European population. The effect of Red Yeast Rice on fasting blood glucose and inflammatory markers will also be investigated. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Hyperlipidemia, Glucose Metabolism Disorders
- What is being tested?
- HYPOCOL®
- How many people
- 40 participants
- Where
- 1 siteNorway
- Study dates
- Mar 2005to Jun 2006
- Phase
- Interventional
- 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 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Provide written informed consent prior to enrolment (any study-specific procedures or investigations).
- Male or female aged between 18 and 75 years.
- Patients with mild Type IIa, Type IIb or IV hyperlipidaemia (LDL-cholesterol >3.0 mmol/L< 6.0 mmol/L)
- Fasting serum TG level < 4.5 mmol/L
- Mildly elevated blood glucose defined as at least one of three of the following criteria
- HbA1c% >5.5% < 7.5%;
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- Fasting glucose > 5.5 mmol/L;
- Type 2 diabetes mellitus on stable oral antihyperglycemic treatment for more than 8 weeks and HbA1c% < 7.5% at the time for inclusion.
- If female, be of non-childbearing potential, i.e., post-menopausal (defined as >12 months since last menstrual period) or surgically sterilised, or using adequate barrier contraception if of childbearing potential.
Who cannot join
- Currently taking lipid-lowering medication and are not able to complete the 4-week wash-out prior to the start of the dietary run-in period.
- History of active malignant disease the last 5 years (excluding treated basal cell carcinoma).
- History of infection with human immunodeficiency virus (HIV) or hepatitis B or C.
- History of alcohol and/or drug abuse.
- Have uncontrolled hypertension (diastolic blood pressure >100 mmHg). Patients who are taking antihypertensive medication will not be excluded provided they are maintained at a stable dose for 3 months prior to screening and the stable dose is maintained throughout the study.
- Have uncontrolled thyroid disease (thyroid dysfunction controlled for at least 6 months prior to screening is permitted).
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- Known homozygous familial hypercholesterolaemia or known Type III hyperlipoproteinaemia (familial dysbetalipoproteinaemia).
- Patients with active liver disease or hepatic dysfunction as defined by elevations in liver enzymes [alanine aminotransferase (ALT), aspartate aminotransferase (AST), gamma glutamyltransferase (GGT) and alkaline phosphatase (ALP)] or total bilirubin >2 x the upper limit of normal (ULN) at any time between Visit 1 (Week -4) and Visit 3 (Week -1).
- Patients with a serum creatinine >180 µmol/L at any time between Visit 1 (Week -4) and Visit 3 (Week -1)
- Patients who have serious or unstable medical or psychological conditions which, in the opinion of the investigator, would compromise the patient's safety or successful participation in the study.
- Patients who started hormone replacement therapy (HRT) less than 6 months prior to screening.
- Currently taking other investigational drugs or have taken part in a clinical trial within the previous 30 days prior to screening.
- These drugs should not be given during the patient's participation in the study, and must be stopped 6 weeks before randomisation : lipid lowering drug other than study medication, Cyclosporine A, medical treatment against obesity (i.e., Orlistat, Sibutramine), oral anticoagulants. Special attention will be paid to the medications that could interfere with the lipid profile (i.e. oral corticosteroids, retinoids, thyroid hormones, thiazide derivative, diuretics, beta-blockers, and hormone replacement therapies). It is recommended not to modify these medications within 6 weeks prior to study start and during the course of the trial (unless this is medically required). All concomitant medications will be recorded.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single-Centre, Randomised Double-Blind Placebo-Controlled Study to Measure the Effect of Hypocol® on Lipids in Subjects With Mild Hypercholesterolemia and Mildly Elevated Blood Glucose
The purpose of this study is to determine to what degree Hypocol® (Red Yeast Rice) may lower low density lipoprotein (LDL)-cholesterol in a European population. The effect of Red Yeast Rice on fasting blood glucose and inflammatory markers will also be investigated.
Read the detailed description
Clinical end-point trials have demonstrated that lowering cholesterol levels with statins reduces the incidence of cardiovascular events and mortality. Subgroup analyses of the large clinical studies, the West of Scotland Coronary Prevention (WOSCOP) and Cholesterol and Recurrent Events (CARE), have suggested that the beneficial effects of statins may extend to mechanisms beyond cholesterol reduction. A variety of mechanisms accounting for these effects have been suggested. Among these, the anti-inflammatory activity is particularly attractive because inflammation is considered an early step in the development of atherosclerosis. Thus, statin therapy has been shown to lower high-sensitivity C-reactive protein (CRP), a plasma marker of inflammation, in hypercholesterolemic patients. Furthermore, statins may possess anti-inflammatory properties by their ability to reduce the number of inflammatory cells in atherosclerotic plaques. Red Yeast Rice contains Lovastatin and lowers LDL-cholesterol. However, it is not known to what degree Red Yeast Rice may lower LDL-cholesterol in a European population. Some reports have suggested an effect of Red Yeast Rice on fasting blood glucose by an unknown mechanism.
- Conditions
- Hyperlipidemia, Glucose Metabolism Disorders
- Being tested
- HYPOCOL®
- Keywords
- Hypocol, Red yeast rice, Patients with mild Type IIa, Type IIb or IV hyperlipidaemia (LDL-cholesterol >3.0 mmol/L< 6.0 mmol/L., Mildly elevated blood glucose
- Medical subject headings
- Hyperlipidemias, Glucose Metabolism Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HYPOCOL®Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
The effect of HypoCol on lipids in subjects with mild hypercholesterolemia.
Secondary outcomes (1)
The effect of HypoCol on fasting glucose, glycosylated hemoglobin (HbA1c) and high sensitive CRP.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2005 (estimated)
- Study startMar 2005
- Primary completionDec 2005
- Study completionJun 2006
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.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Enrolment
- 40 participants
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Pharmalogica, Wearnes Biotech @ Medicals, Beijing Peking University WBL Biotech Co., Ltd.
- Investigators
- Kjetil Retterstøl, Dr. med, Principal investigator, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00114855
- Sponsor's protocol ID
- HYPOCOL protocol 15.12.2004
- Other IDs
- S-04329 (REK Sør), 11850 (NSD), 05/896 TSP (ShDir), 200303963-3 (SLV)
- Status last verified
- Feb 2009
- First submitted
- 17 Jun 2005
- Last updated
- 6 Jul 2011
- Results posted
- No
Publications
Bogsrud MP, Ose L, Langslet G, Ottestad I, Strom EC, Hagve TA, Retterstol K. HypoCol (red yeast rice) lowers plasma cholesterol - a randomized placebo controlled study. Scand Cardiovasc J. 2010 Aug;44(4):197-200. doi: 10.3109/14017431003624123.
PubMed 20636227
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Centre, Randomised Double-Blind Placebo-Controlled Study to Measure the Effect of Hypocol® on Lipids in Subjects With Mild Hypercholesterolemia and Mildly Elevated Blood Glucose
- ClinicalTrials.gov ID
- NCT00114855
- Acronym / sponsor ID
- HYPOCOL protocol 15.12.2004
- Conditions
- Hyperlipidemia, Glucose Metabolism Disorders
- Keywords
- Hypocol, Red yeast rice, Patients with mild Type IIa, Type IIb or IV hyperlipidaemia (LDL-cholesterol >3.0 mmol/L< 6.0 mmol/L., Mildly elevated blood glucose
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Collaborators
- Pharmalogica, Wearnes Biotech @ Medicals, Beijing Peking University WBL Biotech Co., Ltd.
- Study start
- Mar 2005
- Primary completion
- Dec 2005 (actual)
- Study completion
- Jun 2006 (actual)
- First posted
- 20 Jun 2005 (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.
The purpose of this study is to determine to what degree Hypocol® (Red Yeast Rice) may lower low density lipoprotein (LDL)-cholesterol in a European population. The effect of Red Yeast Rice on fasting blood glucose and inflammatory markers will also be investigated.
Detailed description
Clinical end-point trials have demonstrated that lowering cholesterol levels with statins reduces the incidence of cardiovascular events and mortality. Subgroup analyses of the large clinical studies, the West of Scotland Coronary Prevention (WOSCOP) and Cholesterol and Recurrent Events (CARE), have suggested that the beneficial effects of statins may extend to mechanisms beyond cholesterol reduction. A variety of mechanisms accounting for these effects have been suggested. Among these, the anti-inflammatory activity is particularly attractive because inflammation is considered an early step in the development of atherosclerosis. Thus, statin therapy has been shown to lower high-sensitivity C-reactive protein (CRP), a plasma marker of inflammation, in hypercholesterolemic patients. Furthermore, statins may possess anti-inflammatory properties by their ability to reduce the number of inflammatory cells in atherosclerotic plaques. Red Yeast Rice contains Lovastatin and lowers LDL-cholesterol. However, it is not known to what degree Red Yeast Rice may lower LDL-cholesterol in a European population. Some reports have suggested an effect of Red Yeast Rice on fasting blood glucose by an unknown mechanism.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Provide written informed consent prior to enrolment (any study-specific procedures or investigations).
- Male or female aged between 18 and 75 years.
- Patients with mild Type IIa, Type IIb or IV hyperlipidaemia (LDL-cholesterol >3.0 mmol/L< 6.0 mmol/L)
- Fasting serum TG level < 4.5 mmol/L
- Mildly elevated blood glucose defined as at least one of three of the following criteria
Key exclusion criteria (13 listed)
- Currently taking lipid-lowering medication and are not able to complete the 4-week wash-out prior to the start of the dietary run-in period.
- History of active malignant disease the last 5 years (excluding treated basal cell carcinoma).
- History of infection with human immunodeficiency virus (HIV) or hepatitis B or C.
- History of alcohol and/or drug abuse.
- Have uncontrolled hypertension (diastolic blood pressure >100 mmHg). Patients who are taking antihypertensive medication will not be excluded provided they are maintained at a stable dose for 3 months prior to screening and the stable dose is maintained throughout the study.
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 |
|---|---|---|
| HYPOCOL® | Drug | – |
Primary outcome
The effect of HypoCol on lipids in subjects with mild hypercholesterolemia.
1 secondary outcome
The effect of HypoCol on fasting glucose, glycosylated hemoglobin (HbA1c) and high sensitive CRP.
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 6 Jul 2011.
- Derived from this study: PubMed 20636227Bogsrud MP, Ose L, Langslet G, Ottestad I, Strom EC, Hagve TA, Retterstol K. HypoCol (red yeast rice) lowers plasma cholesterol - a randomized placebo controlled study. Scand Cardiovasc J. 2010 Aug;44(4):197-200. doi: 10.3109/14017431003624123.
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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.
Kjetil Retterstøl, Dr. med principal investigator
Oslo University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HYPOCOL® in people with Hyperlipidemia and Glucose Metabolism Disorders, run by Oslo University Hospital at 1 site in Norway.
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 9 inclusion and 13 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 6 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 1 site in Norway. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
The effect of HypoCol on lipids in subjects with mild hypercholesterolemia.. 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 NCT00114855, 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 6 Jul 2011.