LIP-01 in Hypercholesterolemia

Afexa Life Sciences

Status and phase: Completed; Phase 1

Conditions: Hypercholesterolemia

Treatments: Dietary Supplement: LIP-01

Study type: Interventional

Funder types: Industry

Identifiers

NCT00966225

LIP-01-2009-1

Details and patient eligibility

About

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

Enrollment: 40 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 3 patient groups

One gram LIP-01 per day

Experimental group

Description:

One gram LIP-01 per day for 12 weeks

Treatment:

Dietary Supplement: LIP-01

Two grams LIP-01 per day

Experimental group

Description:

Two grams LIP-01 per day for 12 weeks

Treatment:

Dietary Supplement: LIP-01

0.333 grams LIP-01 per day

Experimental group

Description:

0.333 grams LIP-01 per day for 12 weeks

Treatment:

Dietary Supplement: LIP-01