HyperlipidemiasPhase 2BetAvenaNCT03857256
Compare the Efficacy and Safety of Beta-Glucan as Add-On to Statin in Subjects With Hyperlipidemia.
A Phase 2 study testing CP105F in people with Hyperlipidemias, run by Montreal Heart Institute at 1 site in Canada.
Trial summary
The objective of this study is to evaluate the effects of adding beta-glucan (1.5 g, 3 g or 6 g daily) administered three times a day (TID) in divided doses, to atorvastatin (10 mg - 20 mg) once a day or an equivalent dose of another statin on heart disease lipid risk factors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hyperlipidemias
- What is being tested?
- CP105F
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 263 participants
- Where
- 1 siteCanada
- Study dates
- 31 May 2019to 31 Dec 2021
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects must meet ALL of the following inclusion criteria in order to be eligible for this study:
- Male or female ≥18 years of age
- Subjects with hyperlipidemia treated with stable dose of statin for at least 6 weeks; either atorvastatin (10 mg to 20 mg daily) or equivalent dose of another statin at the time of informed consent and with LDL-C level >3.37 mmol/L (130 mg/dL) in fasting conditions at screening
- Subjects willing to maintain stable standard cholesterol lowering diet (Appendix 2) and physical activity level throughout the study
- Female of childbearing potential must have a negative urine pregnancy test at screening and randomization baseline Visit 2
- Women are considered not of childbearing potential if they:
Show all 10Show fewer
- Have had a hysterectomy, a bilateral oophorectomy or tubal ligation prior to Combination Therapy Baseline Visit.
- Are postmenopausal defined as no menses for at least 1 year and have a serum FSH level of 40 IU/L.
- Women of childbearing potential must agree to use an effective method of birth control throughout the study. Acceptable means of birth control include: implantable contraceptives, injectable contraceptives, oral contraceptives, transdermal contraceptives, intrauterine devices, male or female condoms with spermicide, abstinence, or a sterile sexual partner
- Ability and willingness to give written informed consent and to comply with the requirements of the study
Who cannot join
- A subject who meets any of the following criteria will NOT be eligible to the study:
- Use of any other lipid modifying drugs including but not limited to:
- Niacin (nicotinic acid) or niacinamide (nicotinamide)
- Fibrates or fibric acid derivatives including fenofibrate, gemfibrozil, clofibrate
- Bile acid sequestrants including cholestyramine, colesevelam, colestipol
- Ezetimibe
Show all 35Show fewer
- PCSK9 inhibitors
- Systemic corticosteroids
- Use of any other lipid modifying supplements within the last 30 days, including but not limited to (a 30-day wash out period is permitted):
- Beta-glucan supplements other than the investigational product
- Omega-3 fatty acids
- Supplements containing flaxseed, fish oil, or algal oil
- Sterol/stanol products
- Red yeast rice supplements or soy isoflavone supplements
- Dietary fiber supplements including > 2 teaspoonful of Metamucil® or psyllium containing supplements per day
- Supplements containing oats, oatmeal and oat bran.
- Use of nonsteroidal anti-inflammatory drugs (NSAIDs) with the exception of acetylsalicylic acid (ASA) at a concentration of up to 325 mg twice a day
- BMI ≥ 40 kg/m2
- Female who is pregnant, planning to become pregnant during the study, or breast feeding
- Subject who is not willing to keep stable the exercise level during the study
- History of poorly controlled diabetes within the last 3 months (HbA1C >10%)
- Subjects with poorly controlled blood pressure defined as a sustained mean systolic blood pressure 160 or <100 mmHg and/or diastolic blood pressure 100 or <60 mmHg at screening
- History of unstable angina, myocardial infarction, coronary artery bypass graft surgery (CABG), percutaneous coronary intervention (PCI), carotid surgery or stenting, cerebrovascular accident, or transient ischemic attack (TIA) within 6 months prior to screening
- History of heart failure NYHA III-IV within 12 months prior to screening.
- Subjects with clinically significant electrocardiographic abnormalities
- Subjects with history of clinically significant endocrine disease known to influence serum lipids
- Subjects with evidence of hepatic disease (ALT and/or AST greater than 2X ULN, total bilirubin greater than 1.5X ULN, or cirrhosis) at screening
- Renal dysfunction defined as glomerular filtration rate (GFR) ≤45 mL/min/1.73 m2 at screening
- Subjects who suffer from inflammatory bowel disease or irritable bowel syndrome
- Known allergies or intolerance to oats
- History of malignancy, except subjects who have been disease-free for > 3 yrs or resected basal or squamous cell skin carcinoma or cervical carcinoma in situ
- Consumption of > 14 alcoholic drinks per week (1 drink = 12 oz beer, 5 oz wine, or 1.5 oz hard liquor at screening). Counseling should be given to encourage the subject to maintain consumption at or below this level throughout the study
- History of drug abuse
- Participation in another clinical trial within 30 days of signing the Information and Consent Form (ICF)
- Any condition or therapy that the investigator believes might pose a risk to the subject or makes participation in the study not in the subject's best interest
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multicenter, Randomized, Double-Blind, Parallel Group, Placebo-Controlled Study To Compare The Efficacy And Safety Of High-Medium Molecular Weight Beta-Glucan As Add-On To Statin Therapy In Subjects With Hyperlipidemia.
The objective of this study is to evaluate the effects of adding beta-glucan (1.5 g, 3 g or 6 g daily) administered three times a day (TID) in divided doses, to atorvastatin (10 mg - 20 mg) once a day or an equivalent dose of another statin on heart disease lipid risk factors.
Read the detailed description
Male and female subjects ≥ 18 years of age with an elevated LDL-C > 3.37 mmol/L (130 mg/dL) treated with a stable dose of statin for at least 6 weeks (atorvastatin (10-20mg daily) or equivalent dose of another statin), including subject with previous cardiovascular (CV) events, with partial statin intolerance defined as an inability to tolerate statin therapy in the form and dosages required to achieve treatment goals.
Following signature of informed consent, approximately 264 subjects (66 subjects per beta-glucan treatment group and 22 subjects per matching placebo group) meeting all inclusion criteria and no exclusion criteria will be randomized to receive one of the three doses of beta-glucan (1.5 g, 3 g or 6 g daily) administered TID in divided doses or a matching placebo as an add-on therapy to atorvastatin (10- 20 mg administered once daily) or an equivalent dose of another statin.
The subjects will be assigned to the 3 different doses of beta-glucan or placebo in a tiered fashion as follows:
- The first set of 88 subjects randomized will receive either 1.5 g beta-glucan daily (1 tablet of 500 mg TID) or a matching placebo in a 3:1 ratio,
- The next set of 88 subjects randomized will receive either 3 g of beta-glucan daily (2 tablets of 500 mg TID) or a matching placebo in a 3:1 ratio,
- The last set of 88 subjects randomized will receive either 6 g of beta-glucan daily (4 tablets of 500 mg TID) or a matching placebo in a 3:1 ratio.
During the treatment period, subjects will return to the study site at Visit 3 (Week 6) and at the End of Treatment Visit (Week 12) for laboratory tests and clinical assessments, including Adverse Events (AEs), dietary guidance and study product compliance. At the Safety Follow-up Visit (Week 14), subjects will be contacted via telephone for an assessment of AEs.
- Conditions
- Hyperlipidemias
- Being tested
- CP105F, Placebo
- Medical subject headings
- Hyperlipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CP105FDrug
Also called beta-glucan
Natural Health Product
PlaceboDrug
tablet manufactured to mimic the CP105F beta-glucan
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | matching placebo for 12 weeks. Receives: Drug: Placebo |
| Oat beta-glucan 1.5g | Active comparator | CP105F (Oat beta-glucan) 1.5g (1 tablet of 0.5g TID) for 12 weeks. Receives: Drug: CP105F |
| Oat beta-glucan 3g. | Active comparator | CP105F (Oat beta-glucan) 3g (2 tablets of 0.5g TID) for 12 weeks. Receives: Drug: CP105F |
| Oat beta-glucan 6g. | Active comparator | CP105F (Oat beta-glucan) 6g (4 tablets of 0.5g TID) for 12 weeks. Receives: Drug: CP105F |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Direct-measured LDL-C
mg/dL
Measured: week 0 to week 12
Secondary outcomes (6)
Changes in Total Cholesterol,
mmol/L or mg/dL
Measured: week 0 to week 12
Changes in Non-High-density Lipoprotein Cholesterol,
mmol/L or mg/dL
Measured: week 0 to week 12
Changes in Small Low-density Lipoprotein Subclass Particle Concentration,
nmol/l
Measured: week 0 to week 12
Changes in High Sensitivity C-reactive Protein,
mg/L
Measured: week 0 to week 12
Changes in Very Low-density Lipoprotein Cholesterol,
mmol/L or mg/dL
Measured: week 0 to week 12
Changes in Apo B.
mmol/L
Measured: week 0 to week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2019
- Study start31 May 2019
- Primary completion31 Aug 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HyperlipidemiasStudies 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 263 participants (actual)
Sponsor and investigators
- Lead sponsor
- Montreal Heart Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Ceapro Inc., The Montreal Health Innovations Coordinating Center (MHICC)
- Responsible party
- Sponsor
- Investigators
- Jean-Claude Tardif, MD, Principal investigator, Montreal Heart Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03857256
- Sponsor's protocol ID
- PROJ1601
- Acronym
- BetAvena
- Status last verified
- Apr 2023
- First submitted
- 13 Feb 2019
- Last updated
- 16 Jan 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Rioux-Labrecque V, Cossette M, Rufiange M, Bilodeau D, Guertin MC, Tardif JC. Supplementation with a beta-glucan tablet has no effect on hyperlipidemia: a randomized, placebo-controlled clinical trial. Am J Clin Nutr. 2023 Jun;117(6):1232-1239. doi: 10.1016/j.ajcnut.2023.04.012. Epub 2023 Apr 11.
PubMed 37054888
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-Blind, Parallel Group, Placebo-Controlled Study To Compare The Efficacy And Safety Of High-Medium Molecular Weight Beta-Glucan As Add-On To Statin Therapy In Subjects With Hyperlipidemia.
- ClinicalTrials.gov ID
- NCT03857256
- Acronym / sponsor ID
- BetAvena / PROJ1601
- Conditions
- Hyperlipidemias
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 263 participants (actual)
- Lead sponsor
- Montreal Heart InstituteUniversity, hospital or other
- Collaborators
- Ceapro Inc., The Montreal Health Innovations Coordinating Center (MHICC)
- Study start
- 31 May 2019 (actual)
- Primary completion
- 31 Aug 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 27 Feb 2019 (actual)
- Results
- Posted 16 Jan 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to evaluate the effects of adding beta-glucan (1.5 g, 3 g or 6 g daily) administered three times a day (TID) in divided doses, to atorvastatin (10 mg - 20 mg) once a day or an equivalent dose of another statin on heart disease lipid risk factors.
Detailed description
Male and female subjects ≥ 18 years of age with an elevated LDL-C > 3.37 mmol/L (130 mg/dL) treated with a stable dose of statin for at least 6 weeks (atorvastatin (10-20mg daily) or equivalent dose of another statin), including subject with previous cardiovascular (CV) events, with partial statin intolerance defined as an inability to tolerate statin therapy in the form and dosages required to achieve treatment goals.
Following signature of informed consent, approximately 264 subjects (66 subjects per beta-glucan treatment group and 22 subjects per matching placebo group) meeting all inclusion criteria and no exclusion criteria will be randomized to receive one of the three doses of beta-glucan (1.5 g, 3 g or 6 g daily) administered TID in divided doses or a matching placebo as an add-on therapy to atorvastatin (10- 20 mg administered once daily) or an equivalent dose of another statin.
The subjects will be assigned to the 3 different doses of beta-glucan or placebo in a tiered fashion as follows:
- The first set of 88 subjects randomized will receive either 1.5 g beta-glucan daily (1 tablet of 500 mg TID) or a matching placebo in a 3:1 ratio,
- The next set of 88 subjects randomized will receive either 3 g of beta-glucan daily (2 tablets of 500 mg TID) or a matching placebo in a 3:1 ratio,
- The last set of 88 subjects randomized will receive either 6 g of beta-glucan daily (4 tablets of 500 mg TID) or a matching placebo in a 3:1 ratio.
During the treatment period, subjects will return to the study site at Visit 3 (Week 6) and at the End of Treatment Visit (Week 12) for laboratory tests and clinical assessments, including Adverse Events (AEs), dietary guidance and study product compliance. At the Safety Follow-up Visit (Week 14), subjects will be contacted via telephone for an assessment of AEs.
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 |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placebomatching placebo for 12 weeks. |
| Oat beta-glucan 1.5g | Active comparator | Drug: CP105FCP105F (Oat beta-glucan) 1.5g (1 tablet of 0.5g TID) for 12 weeks. |
| Oat beta-glucan 3g. | Active comparator | Drug: CP105FCP105F (Oat beta-glucan) 3g (2 tablets of 0.5g TID) for 12 weeks. |
| Oat beta-glucan 6g. | Active comparator | Drug: CP105FCP105F (Oat beta-glucan) 6g (4 tablets of 0.5g TID) for 12 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Subjects must meet ALL of the following inclusion criteria in order to be eligible for this study:
- Male or female ≥18 years of age
- Subjects with hyperlipidemia treated with stable dose of statin for at least 6 weeks; either atorvastatin (10 mg to 20 mg daily) or equivalent dose of another statin at the time of informed consent and with LDL-C level >3.37 mmol/L (130 mg/dL) in fasting conditions at screening
- Subjects willing to maintain stable standard cholesterol lowering diet (Appendix 2) and physical activity level throughout the study
- Female of childbearing potential must have a negative urine pregnancy test at screening and randomization baseline Visit 2
Key exclusion criteria (35 listed)
- Use of any other lipid modifying drugs including but not limited to:
- Use of any other lipid modifying supplements within the last 30 days, including but not limited to (a 30-day wash out period is permitted):
- Use of nonsteroidal anti-inflammatory drugs (NSAIDs) with the exception of acetylsalicylic acid (ASA) at a concentration of up to 325 mg twice a day
- BMI ≥ 40 kg/m2
- Female who is pregnant, planning to become pregnant during the study, or breast feeding
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 |
|---|---|---|
| CP105FAlso: beta-glucanNatural Health Product | Drug | Oat beta-glucan 1.5g, Oat beta-glucan 3g., Oat beta-glucan 6g. |
| Placebotablet manufactured to mimic the CP105F beta-glucan | Drug | Placebo |
Primary outcome
Change in Direct-measured LDL-C
Time frame: week 0 to week 12
mg/dL
6 secondary outcomes
Changes in Total Cholesterol,
Time frame: week 0 to week 12
Changes in Non-High-density Lipoprotein Cholesterol,
Time frame: week 0 to week 12
Changes in Small Low-density Lipoprotein Subclass Particle Concentration,
Time frame: week 0 to week 12
Changes in High Sensitivity C-reactive Protein,
Time frame: week 0 to week 12
Changes in Very Low-density Lipoprotein Cholesterol,
Time frame: week 0 to week 12
Changes in Apo B.
Time frame: week 0 to week 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37054888Rioux-Labrecque V, Cossette M, Rufiange M, Bilodeau D, Guertin MC, Tardif JC. Supplementation with a beta-glucan tablet has no effect on hyperlipidemia: a randomized, placebo-controlled clinical trial. Am J Clin Nutr. 2023 Jun;117(6):1232-1239. doi: 10.1016/j.ajcnut.2023.04.012. Epub 2023 Apr 11.
- Individual participant dataSharing planned: No
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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.
Jean-Claude Tardif, MD principal investigator
Montreal Heart Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CP105F in people with Hyperlipidemias, run by Montreal Heart Institute at 1 site in Canada.
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 10 inclusion and 35 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 16 Jan 2024. 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 Canada. 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 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Jan 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in Direct-measured LDL-C (time frame: week 0 to week 12). 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 NCT03857256, 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 16 Jan 2024.