LIP-01 in Hypercholesterolemia

An Open-label Dose-finding Study of LIP-01 in Otherwise Healthy Individuals With Hypercholesterolemia

The purpose of this study is to determine a safe and tolerable dose of LIP-01

Study Overview

• Status: Completed
• Conditions: Hypercholesterolemia
• Intervention / Treatment: Dietary supplement: LIP-01

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 1

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Edmonton, Alberta, Canada, T6G 2C8
      • The Northern Alberta Clinical Trials and Research Centre
• United States
  • California
    • Northridge, California, United States, 91325
      • Medicus Research, LLC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Age between 18-75 years
• Plasma total-cholesterol >5.2 mmol/L (> 200 mg/dL)
• Willingness to adhere to the requirements of the protocol, including availability for follow-up visits and donation of blood samples
• Willingness and ability to sign written informed consent
• Women of child bearing capacity who agree to use an acceptable form of birth control during the trial [i.e., oral contraception, reliable use of a double-barrier method (e.g., condom and diaphragm, condom and foam, condom and sponge), IUD or tubal ligation]

Exclusion Criteria:

• Plasma triglycerides > 4.0 mmol/L (> 354 mg/dL)
• Plasma LDL ≥ 5.0 mmol/L (≥ 195 mg/dL)
• Current coronary artery/ cardiovascular disease or history of a cardiovascular event (stroke, transient ischemic attack, myocardial infarction, angioplasty or coronary artery bypass grafting, angina pectoris)
• Moderate/high risk of coronary artery/ cardiovascular disease
• Diabetes mellitus
• Uncorrected hypothyroidism
• Other significant metabolic endocrine disease
• Uncontrolled hypertension (>160 systolic or >100 diastolic)
• Active liver disease (ALT >2x normal)
• Significant gastrointestinal disease
• Acute inflammatory disease
• Significant kidney disease (calculated by eGFR <60 mL/min)
• Any other significant medical condition which, in the opinion of the investigator, could compromise patient safety or confound trial results
• Any significant/relevant surgery within the last year
• Use of lipid-lowering drugs
• Treatment within the previous 6 months with any medication that is known to affect lipid or lipoprotein levels (such as statins, fibric acid derivatives, bile acid sequestrants, ezetimibe, nicotinic acid)
• Regular use of natural health products or dietary supplements known to affect lipid or lipoprotein levels (omega-3 fatty acids, green tea extracts, guggulipid, psyllium, plant sterols, policosanols). If the participants agree to stop taking these products prior to study entry and for the duration of the study, they can participate in the study.
• Pregnant or lactating women
• Known allergy to any ingredient in the study product, including: Coptis chinensis, Ilex kudingcha, microcrystalline cellulose and magnesium stearate

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: One gram LIP-01 per day; One gram LIP-01 per day for 12 weeks	Dietary supplement: LIP-01; comparison of different dosages of natural health product
Experimental: Two grams LIP-01 per day; Two grams LIP-01 per day for 12 weeks	Dietary supplement: LIP-01; comparison of different dosages of natural health product
Experimental: 0.333 grams LIP-01 per day; 0.333 grams LIP-01 per day for 12 weeks	Dietary supplement: LIP-01; comparison of different dosages of natural health product

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
To determine a safe and tolerable dose of LIP-01	12 weeks

Collaborators and Investigators

• Sponsor: Afexa Life Sciences Inc
• Investigators: Principal Investigator: Richard Lewanczuk, MD, PhD, FRCPC, University of Alberta

Study record dates

Study Major Dates

• Study Start: September 1, 2009
• Primary Completion (Actual): January 1, 2012
• Study Completion (Actual): January 1, 2012

Study Registration Dates

• First Submitted: August 18, 2009
• First Submitted That Met QC Criteria: August 24, 2009
• First Posted (Estimate): August 26, 2009

Study Record Updates

• Last Update Posted (Estimate): January 31, 2012
• Last Update Submitted That Met QC Criteria: January 26, 2012
• Last Verified: January 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Lipid Metabolism Disorders; Hyperlipidemias; Dyslipidemias; Hypercholesterolemia
• Other Study ID Numbers: LIP-01-2009-1