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LIP-01 in Hypercholesterolemia

Primary Purpose

Hypercholesterolemia

Status

Completed

Phase

Phase 1

Locations

International

Study Type

Interventional

Intervention

LIP-01

About this trial

This is an interventional treatment trial for Hypercholesterolemia

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Medicus Research, LLC
The Northern Alberta Clinical Trials and Research Centre

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

One gram LIP-01 per day

Two grams LIP-01 per day

0.333 grams LIP-01 per day

Arm Description

One gram LIP-01 per day for 12 weeks

Two grams LIP-01 per day for 12 weeks

0.333 grams LIP-01 per day for 12 weeks

Outcomes

Primary Outcome Measures

To determine a safe and tolerable dose of LIP-01

Secondary Outcome Measures

Full Information

NCT ID

NCT00966225

First Posted

August 18, 2009

Last Updated

January 26, 2012

Sponsor

Afexa Life Sciences Inc

1. Study Identification

Unique Protocol Identification Number

NCT00966225

Brief Title

LIP-01 in Hypercholesterolemia

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2012

Overall Recruitment Status

Completed

Study Start Date

September 2009 (undefined)

Primary Completion Date

January 2012 (Actual)

Study Completion Date

January 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Afexa Life Sciences Inc

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hypercholesterolemia

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

40 (Actual)

8. Arms, Groups, and Interventions

Arm Title

One gram LIP-01 per day

Arm Type

Experimental

Arm Description

One gram LIP-01 per day for 12 weeks

Arm Title

Two grams LIP-01 per day

Arm Type

Experimental

Arm Description

Two grams LIP-01 per day for 12 weeks

Arm Title

0.333 grams LIP-01 per day

Arm Type

Experimental

Arm Description

0.333 grams LIP-01 per day for 12 weeks

Intervention Type

Dietary Supplement

Intervention Name(s)

LIP-01

Intervention Description

comparison of different dosages of natural health product

Primary Outcome Measure Information:

Title

To determine a safe and tolerable dose of LIP-01

Time Frame

12 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Richard Lewanczuk, MD, PhD, FRCPC

Organizational Affiliation

University of Alberta

Official's Role

Principal Investigator

Facility Information:

Facility Name

Medicus Research, LLC

City

Northridge

State/Province

California

ZIP/Postal Code

91325

Country

United States

Facility Name

The Northern Alberta Clinical Trials and Research Centre

City

Edmonton

State/Province

Alberta

ZIP/Postal Code

T6G 2C8

Country

Canada

12. IPD Sharing Statement

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LIP-01 in Hypercholesterolemia

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