GPur- Luminating Oral Cholesterol Kinetics Pilot Study

Completed · Not applicable

Conditions studied: Cholesterol Absorption

In brief

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.

Key facts

Study ID

NCT03090542

Run by

Canadian Collaborative Research Network

People needed

22

Starts

2017-06-01

Expected to finish

2018-01-15

Last updated by the study team

2018-01-25

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• Atlanta Heart Specialists — Cumming, Georgia, United States

Full record on ClinicalTrials.gov

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