GPur- Luminating Oral Cholesterol Kinetics Pilot Study (GLOCK-pilot)

Canadian Collaborative Research Network

Status

Completed

Conditions

Cholesterol Absorption

Treatments

Dietary Supplement: clinoptilolite

Study type

Interventional

Funder types

Other

Identifiers

NCT03090542

GLOCK-Pilot 2017

Details and patient eligibility

About

In healthy subjects not receiving or requiring lipid lowering therapy and who do not have diabetes, the use of clinoptilolite (GPUR) will result in a reduction of absorbed dietary cholesterol observed over 6 days of therapy.

Enrollment

22 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Adults over 18 years of age
Not receiving or requiring lipid lowering therapy
Willingness to give informed consent
Able to keep a dietary log
Willing to maintain a consistent day to day routine during the study (no major changes in lifestyle, exercise, food pattern, smoking habits, etc)

Exclusion criteria

Current use of oral lipid binding agents (colesevelam, cholestyramine, ezetimibe) fibrates, niacin or statins
Current use of dietary supplements enriched with fat soluble vitamins, mono/polyunsaturated fat (fish-oil etc.) or probiotics
Any oral antibiotic use, currently or within the past 14 days
Diabetes, Type I and Type II
Currently following a restrictive diet
GI motility disorders (irritable bowel syndrome, diabetic gastroparesis, etc)
Prior gastric or bowel resection
Inflammatory bowel disease (Crohns, ulcerative colitis, diverticulitis, celiac sprue, etc)
Co-morbidities with anticipated life expectancy < 12 months
ESRD on dialysis
Known intolerance to silicium or aluminum compounds
Excess alcohol consumption (>1 drink per day)
Pregnancy, nursing or not taking/using contraception
Hepatobiliary disorders or renal disease
Plasma total cholesterol > 240mg/dl or Triglycerides > 265.5 mg/dl
No plant-sterol enriched food products allowed in diet & supplements
BMI > 35