GPur- Luminating Oral Cholesterol Kinetics Pilot Study

Study Overview
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Brief Summary
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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.

Official Title
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39 Day Randomized, Open Label, Two Arm Cross Over Study of Clinoptilolite (Gpur) in Healthy Adult Subjects Not Requiring or Receiving Lipid Lowering Therapy

Conditions
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Cholesterol Absorption

Intervention / Treatment
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* Dietary Supplement: clinoptilolite


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br> | |
| Active Comparator: Product<br> | Dietary Supplement: clinoptilolite<br>* randomized, open-label, cross-over study of control vs clinoptilolite with a washout period separating the 2 phases<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent change in fractional cholesterol absorption in human subjects taking clinoptilolite over 6 days | Primary Objective | 39 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent change from baseline by gender to determine gender difference in fractional cholesterol absorption rates | Secondary Objective | 39 days | 
| Percent change from baseline to end of treatment to evaluate for safety changes in metabolic profile measurements | Secondary Objective | 39 days |