LIP-01 in Hypercholesterolemia

NCT ID: NCT00966225

Last Updated: 2012-01-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-09-30
• Study Completion Date: 2012-01-31

Brief Summary

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

Conditions

Hypercholesterolemia

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

One gram LIP-01 per day

One gram LIP-01 per day for 12 weeks

Group Type: EXPERIMENTAL

LIP-01

Intervention Type: DIETARY_SUPPLEMENT

comparison of different dosages of natural health product

Two grams LIP-01 per day

Two grams LIP-01 per day for 12 weeks

Group Type: EXPERIMENTAL

LIP-01

Intervention Type: DIETARY_SUPPLEMENT

comparison of different dosages of natural health product

0.333 grams LIP-01 per day

0.333 grams LIP-01 per day for 12 weeks

Group Type: EXPERIMENTAL

LIP-01

Intervention Type: DIETARY_SUPPLEMENT

comparison of different dosages of natural health product

Interventions

LIP-01

comparison of different dosages of natural health product

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Afexa Life Sciences Inc

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Richard Lewanczuk, MD, PhD, FRCPC

Role: PRINCIPAL_INVESTIGATOR

University of Alberta

Locations

Medicus Research, LLC

Northridge, California, United States

The Northern Alberta Clinical Trials and Research Centre

Edmonton, Alberta, Canada

Countries

United States; Canada

Other Identifiers

LIP-01-2009-1

Identifier Type: -

Identifier Source: org_study_id