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LIP-01 in Hypercholesterolemia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Afexa Life Sciences Inc
ClinicalTrials.gov Identifier:
NCT00966225
First received: August 18, 2009
Last updated: January 26, 2012
Last verified: January 2012
History of Changes
  Purpose

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


Condition Intervention Phase
Hypercholesterolemia
 Dietary Supplement: LIP-01
 Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-label Dose-finding Study of LIP-01 in Otherwise Healthy Individuals With Hypercholesterolemia

Resource links provided by NLM:

MedlinePlus related topics: Cholesterol
U.S. FDA Resources

Further study details as provided by Afexa Life Sciences Inc:

Primary Outcome Measures:
  • To determine a safe and tolerable dose of LIP-01 [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 40
Study Start Date: September 2009
Study Completion Date: January 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00966225

Locations
United States, California
Medicus Research, LLC
Northridge, California, United States, 91325
Canada, Alberta
The Northern Alberta Clinical Trials and Research Centre
Edmonton, Alberta, Canada, T6G 2C8
Sponsors and Collaborators
Afexa Life Sciences Inc
Investigators
Principal Investigator: Richard Lewanczuk, MD, PhD, FRCPC University of Alberta
  More Information

No publications provided

Responsible Party: Afexa Life Sciences Inc
ClinicalTrials.gov Identifier: NCT00966225     History of Changes
Other Study ID Numbers: LIP-01-2009-1
Study First Received: August 18, 2009
Last Updated: January 26, 2012
Health Authority: Canada: Health Canada

Additional relevant MeSH terms:
Hypercholesterolemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on May 19, 2013