NCT00966225

Brief Summary

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

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Sep 2009

Typical duration for phase_1

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 18, 2009

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 26, 2009

Completed
6 days until next milestone

Study Start

First participant enrolled

September 1, 2009

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2012

Completed
Last Updated

January 31, 2012

Status Verified

January 1, 2012

Enrollment Period

2.3 years

First QC Date

August 18, 2009

Last Update Submit

January 26, 2012

Conditions

Hypercholesterolemia

Outcome Measures

Primary Outcomes (1)

  • To determine a safe and tolerable dose of LIP-01

    12 weeks

Study Arms (3)

One gram LIP-01 per day

EXPERIMENTAL

One gram LIP-01 per day for 12 weeks

Dietary Supplement: LIP-01

Two grams LIP-01 per day

EXPERIMENTAL

Two grams LIP-01 per day for 12 weeks

Dietary Supplement: LIP-01

0.333 grams LIP-01 per day

EXPERIMENTAL

0.333 grams LIP-01 per day for 12 weeks

Dietary Supplement: LIP-01

Interventions

LIP-01DIETARY_SUPPLEMENT

comparison of different dosages of natural health product

0.333 grams LIP-01 per dayOne gram LIP-01 per dayTwo grams LIP-01 per day

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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 \[i.e., oral contraception, reliable use of a double-barrier method (e.g., condom and diaphragm, condom and foam, condom and sponge), IUD or tubal ligation\]

You may not qualify if:

  • 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
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Medicus Research, LLC

Northridge, California, 91325, United States

Location

The Northern Alberta Clinical Trials and Research Centre

Edmonton, Alberta, T6G 2C8, Canada

Location

MeSH Terms

Conditions

Hypercholesterolemia

Condition Hierarchy (Ancestors)

HyperlipidemiasDyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Richard Lewanczuk, MD, PhD, FRCPC

    University of Alberta

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 18, 2009

First Posted

August 26, 2009

Study Start

September 1, 2009

Primary Completion

January 1, 2012

Study Completion

January 1, 2012

Last Updated

January 31, 2012

Record last verified: 2012-01

Locations

US(1)CA(1)