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

NCT03857256 | Completed Phase 2 Results

• 1 other identifier: PROJ1601
• Study Type: interventional
• Target: 263
• Locations: 1 country
• Sites: 1

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 or an equivalent dose of another statin on heart disease lipid risk factors.

Conditions

Hyperlipidemias

Outcome Measures

Primary Outcomes (1)

• Change in Direct-measured LDL-C

  mg/dL

  week 0 to week 12

Secondary Outcomes (6)

• Changes in Total Cholesterol,

  week 0 to week 12

• Changes in Non-High-density Lipoprotein Cholesterol,

  week 0 to week 12

• Changes in Small Low-density Lipoprotein Subclass Particle Concentration,

  week 0 to week 12

• Changes in High Sensitivity C-reactive Protein,

  week 0 to week 12

• Changes in Very Low-density Lipoprotein Cholesterol,

  week 0 to week 12

Other Outcomes (4)

• Changes in HDL-C

  week 0 to week 12

• Changes in Triglycerides,

  week 0 to week 12

• Changes in Lipoprotein (a) (Lp(a))

  week 0 to week 12

Study Arms (4)

Placebo

PLACEBO COMPARATOR

matching placebo for 12 weeks.

Drug: Placebo

Oat beta-glucan 1.5g

ACTIVE COMPARATOR

CP105F (Oat beta-glucan) 1.5g (1 tablet of 0.5g TID) for 12 weeks.

Drug: CP105F

Oat beta-glucan 3g.

ACTIVE COMPARATOR

CP105F (Oat beta-glucan) 3g (2 tablets of 0.5g TID) for 12 weeks.

Drug: CP105F

Oat beta-glucan 6g.

ACTIVE COMPARATOR

CP105F (Oat beta-glucan) 6g (4 tablets of 0.5g TID) for 12 weeks.

Drug: CP105F

Interventions

CP105F DRUG

Natural Health Product

Also known as: beta-glucan

Oat beta-glucan 1.5g; Oat beta-glucan 3g.; Oat beta-glucan 6g.

Placebo DRUG

tablet manufactured to mimic the CP105F beta-glucan

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Montreal Heart Institute: lead
• Ceapro Inc.: collaborator
• The Montreal Health Innovations Coordinating Center (MHICC): collaborator

Study Sites (1)

Montreal Heart Institute

Montreal, Quebec, H1T1C8, Canada

Location

Related Publications (1)

• 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.

  PMID: 37054888 DERIVED

MeSH Terms

Conditions

Hyperlipidemias

Interventions

beta-Glucans

Condition Hierarchy (Ancestors)

Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Glucans; Polysaccharides; Carbohydrates

Results Point of Contact

• Title: Dr Jean-Claude Tardif
• Organization: Montreal Heart Institute

jean-claude.tardif@icm-mhi.org

514-376-3330

Study Officials

• Jean-Claude Tardif, MD

  Montreal Heart Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 13, 2019
• First Posted: February 27, 2019
• Study Start: May 31, 2019
• Primary Completion: August 31, 2021
• Study Completion: December 31, 2021
• Last Updated: January 16, 2024
• Results First Posted: January 16, 2024

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)