Low-Moderate HypercholesterolemiaNCT03828006
Clinical Trial to Demonstrate the Efficacy of a Dietary Supplement in Decreasing Cardiovascular Risk
A study testing Red Rice Yeast in people with Low-Moderate Hypercholesterolemia, run by Bioksan at 3 sites in Spain.
Trial summary
This clinical trial seeks to verify the efficacy of a red rice yeast dietary supplement in the decrease of cardiovascular risk, by assessing variables related with cardiovascular risk as levels of cholesterol, triglycerides and transaminases among other, in two groups of participants that will be taking either the… Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Low-Moderate Hypercholesterolemia
- What is being tested?
- Red Rice Yeast
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 3 sitesSpain
- Study dates
- 13 Dec 2018to 30 Nov 2020
- 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 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years old or older
- Body Mass Index (BMI) between 18.5 y 29.9.
- LDL-c levels between 100mg/dL and 160mg/dL
- 10 year estimated cardiovascular risk assessed by the ASCVD less than 20%
- Accepts to participate and sings Informed Consent.
Who cannot join
- Patients with history of cardiovascular diseases.
- Patients with secondary hyperlipidemia caused by diabetes mellitus, or kidney, liver or thyroid diseases.
- Patients with muscle diseases
- Patients undergoing pharmacological treatment with any of the following: lipid lowering agents, antifungal, macrolides, or hormone replacement therapy in progress or during the last 2 months.
- Patients with proven intolerance with the components present in the dietary supplement.
- Patients with any other concomitant disease that to the researcher's criteria are not susceptible to participate in the study.
- Woman that are pregnant, in breastfeeding period or with a possibility of starting a pregnancy.
Trial locations and contacts
3 sites in 1 country.
Spain3 sites
Hospital Universitari de Bellvitge
Barcelona, Catalonia
Hospitales San Roque
Las Palmas de Gran Canaria, Canary Islands
Hospital General Universitari de València
Valencia
About this study
Official title: Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Clinical Trial to Demonstrate the Efficacy of a Dietary Supplement in Decreasing Cardiovascular Risk
This clinical trial seeks to verify the efficacy of a red rice yeast dietary supplement in the decrease of cardiovascular risk, by assessing variables related with cardiovascular risk as levels of cholesterol, triglycerides and transaminases among other, in two groups of participants that will be taking either the dietary supplement or a placebo during a six months period.
- Conditions
- Low-Moderate Hypercholesterolemia
- Being tested
- Red Rice Yeast, Placebo Group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Red Rice YeastDietary supplement
Participants will take one tablet per day of a dietary supplement based on red rice yeas for a period of six months
Placebo GroupOther
Participants of this group will take one tablet of placebo per day for a period of six months
| Study group | Role | What they receive |
|---|---|---|
| Active Group | Experimental | One tablet per day through oral administration of a dietary supplement containing red rice yeast as the main active ingredient Receives: Dietary Supplement: Red Rice Yeast |
| Placebo Group | Placebo comparator | One tablet per day of placebo. Receives: Other: Placebo Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Systematic Coronary Risk Evaluation (SCORE)
This scale estimates the 10 year risk of fatal CVD.
The risk is estimated with a High \& Low cardiovascular Risk Charts based on gender, age, total cholesterol, systolic blood pressure and smoking status, with relative risk chart, qualifiers and instructions. High risk or low risk table depends on whether the person lives in a high or low risk country.
There possible scores goes from 0 to 47 in the high risk table, and 0 to 26 in the low risk table. Where lower values represent lower risk and higher values higher risk.
Measured: Changes in the score from the baseline, at 3 and 6 months.
Arteriosclerotic Cardiovascular Disease Algorithm (ASCVD)
Calculates 10-year risk of heart disease or stroke using the ASCVD algorithm published in 2013 American College of Cardiology/American Heart Association (ACC/AHA) Guidelines on de Assessment of Cardiovascular Risk.
Measured: Changes in the score from the baseline, at 3 and 6 months.
Registre Gironi del Cor (REGICOR)
The scale measures the probability of having cardiovascular disease in 10 years.
The probability is estimated with age, sex, smoking status, diabetic or not, total Cholesterol (mg/dl), HDL cholesterol (mg/dl), systolic blood pressure (mmHg) and diastolic blood pressure (mmHg).
Possible risk values are divided in 5 categories: low <5%, moderate 6-9%, medium 10-19%, high 20-38%, very high >39%
Measured: Changes in the score from the baseline, at 3 and 6 months.
Secondary outcomes (10)
Changes in LDL cholesterol levels in blood
LDL in blood measured in mg/dL Measurements will be taken at basal visit, at 3 months and at 6 months after the start of the dietary supplement/placebo intake.
Measured: Changes in the cholesterol levels from the baseline, at 3 and 6 months.
Changes in HDL cholesterol levels in blood
HDL cholesterol will be measured in mg/dl Measurements will be taken at basal visit, at 3 months and at 6 months after the start of the dietary supplement/placebo intake.
Measured: Changes in the cholesterol levels from the baseline, at 3 and 6 months.
Changes in triglycerides levels in blood
Triglycerides will be measured in mg/dl Measurements will be taken at basal visit, at 3 months and at 6 months after the start of the dietary supplement/placebo intake.
Measured: Changes in the triglyceride levels from the baseline, at 3 and 6 months.
Changes in lipoprotein levels in blood
Lipoproteins will be measured in mg/dl Measurements will be taken at basal visit, at 3 months and at 6 months after the start of the dietary supplement/placebo intake.
Measured: Changes in the lipoprotein levels from the baseline, at 3 and 6 months.
Levels of glycosylated hemoglobin in blood
Glycosylated Hemoglobin (HbA1c) will be measured as % in blood Measurements will be taken at basal visit, at 3 months and at 6 months after the start of the dietary supplement/placebo intake.
Measured: Changes in the lipoprotein levels from the baseline, at 3 and 6 months.
Alanine Transaminase (ALT) levels
Levels of ALT Transaminase measured in IU/L. Measurements will be taken at basal visit, at 3 months and at 6 months after the start of the dietary supplement/placebo intake.
Measured: Changes in the lipoprotein levels from the baseline, at 3 and 6 months.
Adverse Events
Number of adverse events.
Measured: Through study completion, an average of 9 months
Therapeutic adherence
Data will be collected by the investigator at participant visits with a unique question about percentage of intake. It will be considered a good compliance if the 80% of the medication has been taken.
Measured: At the 6 month visit
Morisky-Green scale
The Morisky-Green scale measures treatment adherence with four yes or no questions.
In which yes punctuates 0 and no punctuates 1.
Possible result values goes from 0 to 4, being 0 less adherence and 4 more adherence.
Measured: At the 6 month visit
Recount of returned product
The number of returned product will be counted
Measured: At the 6 month visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2019
- Study start13 Dec 2018
- Primary completion30 Nov 2020
- Study completion30 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low-Moderate HypercholesterolemiaStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bioksan
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Analysis and Research Network, S.L
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03828006
- Sponsor's protocol ID
- BIO-LIP-01-18
- Status last verified
- Jul 2022
- First submitted
- 10 Jan 2019
- Last updated
- 21 Jul 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Clinical Trial to Demonstrate the Efficacy of a Dietary Supplement in Decreasing Cardiovascular Risk
- ClinicalTrials.gov ID
- NCT03828006
- Acronym / sponsor ID
- BIO-LIP-01-18
- Conditions
- Low-Moderate Hypercholesterolemia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- BioksanIndustry (pharma, biotech, devices)
- Collaborators
- Analysis and Research Network, S.L
- Study start
- 13 Dec 2018 (actual)
- Primary completion
- 30 Nov 2020 (actual)
- Study completion
- 30 Nov 2020 (actual)
- First posted
- 4 Feb 2019 (actual)
- 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.
This clinical trial seeks to verify the efficacy of a red rice yeast dietary supplement in the decrease of cardiovascular risk, by assessing variables related with cardiovascular risk as levels of cholesterol, triglycerides and transaminases among other, in two groups of participants that will be taking either the dietary supplement or a placebo during a six months period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active Group | Experimental | Dietary Supplement: Red Rice YeastOne tablet per day through oral administration of a dietary supplement containing red rice yeast as the main active ingredient |
| Placebo Group | Placebo comparator | Other: Placebo GroupOne tablet per day of placebo. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 18 years old or older
- Body Mass Index (BMI) between 18.5 y 29.9.
- LDL-c levels between 100mg/dL and 160mg/dL
- 10 year estimated cardiovascular risk assessed by the ASCVD less than 20%
- Accepts to participate and sings Informed Consent.
Key exclusion criteria (7 listed)
- Patients with history of cardiovascular diseases.
- Patients with secondary hyperlipidemia caused by diabetes mellitus, or kidney, liver or thyroid diseases.
- Patients with muscle diseases
- Patients undergoing pharmacological treatment with any of the following: lipid lowering agents, antifungal, macrolides, or hormone replacement therapy in progress or during the last 2 months.
- Patients with proven intolerance with the components present in the dietary supplement.
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 Rice YeastParticipants will take one tablet per day of a dietary supplement based on red rice yeas for a period of six months | Dietary supplement | Active Group |
| Placebo GroupParticipants of this group will take one tablet of placebo per day for a period of six months | Other | Placebo Group |
Primary outcome
Systematic Coronary Risk Evaluation (SCORE)
Time frame: Changes in the score from the baseline, at 3 and 6 months.
This scale estimates the 10 year risk of fatal CVD. The risk is estimated with a High \& Low cardiovascular Risk Charts based on gender, age, total cholesterol, systolic blood pressure and smoking status, with relative risk chart, qualifiers and instructions. High risk or low risk table depends on whether the person lives in a high or low risk country. There possible scores goes from 0 to 47 in the high risk table, and 0 to 26 in the low risk table. Where lower values represent lower risk and higher values higher risk.
Arteriosclerotic Cardiovascular Disease Algorithm (ASCVD)
Time frame: Changes in the score from the baseline, at 3 and 6 months.
Calculates 10-year risk of heart disease or stroke using the ASCVD algorithm published in 2013 American College of Cardiology/American Heart Association (ACC/AHA) Guidelines on de Assessment of Cardiovascular Risk.
Registre Gironi del Cor (REGICOR)
Time frame: Changes in the score from the baseline, at 3 and 6 months.
The scale measures the probability of having cardiovascular disease in 10 years. The probability is estimated with age, sex, smoking status, diabetic or not, total Cholesterol (mg/dl), HDL cholesterol (mg/dl), systolic blood pressure (mmHg) and diastolic blood pressure (mmHg). Possible risk values are divided in 5 categories: low <5%, moderate 6-9%, medium 10-19%, high 20-38%, very high >39%
10 secondary outcomes
Changes in LDL cholesterol levels in blood
Time frame: Changes in the cholesterol levels from the baseline, at 3 and 6 months.
Changes in HDL cholesterol levels in blood
Time frame: Changes in the cholesterol levels from the baseline, at 3 and 6 months.
Changes in triglycerides levels in blood
Time frame: Changes in the triglyceride levels from the baseline, at 3 and 6 months.
Changes in lipoprotein levels in blood
Time frame: Changes in the lipoprotein levels from the baseline, at 3 and 6 months.
Levels of glycosylated hemoglobin in blood
Time frame: Changes in the lipoprotein levels from the baseline, at 3 and 6 months.
Alanine Transaminase (ALT) levels
Time frame: Changes in the lipoprotein levels from the baseline, at 3 and 6 months.
Adverse Events
Time frame: Through study completion, an average of 9 months
Therapeutic adherence
Time frame: At the 6 month visit
Morisky-Green scale
Time frame: At the 6 month visit
Recount of returned product
Time frame: At the 6 month visit
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 21 Jul 2022.
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.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Red Rice Yeast in people with Low-Moderate Hypercholesterolemia, run by Bioksan at 3 sites in Spain.
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 5 inclusion and 7 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 21 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Spain. 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.
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?
Systematic Coronary Risk Evaluation (SCORE) (time frame: Changes in the score from the baseline, at 3 and 6 months.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Jul 2022.