GPur- Luminating Oral Cholesterol Kinetics Pilot Study
Not Applicable
Completed
- Conditions
- Cholesterol Absorption
- Interventions
- Dietary Supplement: clinoptilolite
- Registration Number
- NCT03090542
- Lead Sponsor
- Canadian Collaborative Research Network
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 22
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Product clinoptilolite -
- Primary Outcome Measures
Name Time Method Percent change in fractional cholesterol absorption in human subjects taking clinoptilolite over 6 days 39 days Primary Objective
- Secondary Outcome Measures
Name Time Method Percent change from baseline by gender to determine gender difference in fractional cholesterol absorption rates 39 days Secondary Objective
Percent change from baseline to end of treatment to evaluate for safety changes in metabolic profile measurements 39 days Secondary Objective
Trial Locations
- Locations (1)
Atlanta Heart Specialists
🇺🇸Cumming, Georgia, United States