Status:
COMPLETED
Compare the Efficacy and Safety of Beta-Glucan as Add-On to Statin in Subjects With Hyperlipidemia.
Lead Sponsor:
Montreal Heart Institute
Collaborating Sponsors:
Ceapro Inc.
The Montreal Health Innovations Coordinating Center (MHICC)
Conditions:
Hyperlipidemias
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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...
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 ...
Eligibility Criteria
Inclusion
- 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:
- 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
Exclusion
- 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
- 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
Key Trial Info
Start Date :
May 31 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2021
Estimated Enrollment :
263 Patients enrolled
Trial Details
Trial ID
NCT03857256
Start Date
May 31 2019
End Date
December 31 2021
Last Update
January 16 2024
Active Locations (1)
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1
Montreal Heart Institute
Montreal, Quebec, Canada, H1T1C8