Compare the Efficacy and Safety of Beta-Glucan as Add-On to Statin in Subjects With Hyperlipidemia.

Inclusion Criteria

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 Criteria

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 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