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OpenTrials
Completed

NCT Number: NCT03090542

GPur- Luminating Oral Cholesterol Kinetics Pilot Study

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.

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Key information

Conditions

Cholesterol Absorption

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Atlanta Heart Specialists

Cumming, Georgia, 30041, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

clinoptilolite

Dietary Supplement

randomized, open-label, cross-over study of control vs clinoptilolite with a washout period separating the 2 phases

Primary outcomes

  1. Percent change in fractional cholesterol absorption in human subjects taking clinoptilolite over 6 days

    Time frame: 39 days

    Primary Objective

Secondary outcomes

  1. Percent change from baseline by gender to determine gender difference in fractional cholesterol absorption rates

    Time frame: 39 days

    Secondary Objective

  2. Percent change from baseline to end of treatment to evaluate for safety changes in metabolic profile measurements

    Time frame: 39 days

    Secondary Objective

Sponsors and collaborators

Lead sponsor

Canadian Collaborative Research Network

Other

Collaborators

  • GLOCK HEALTH, Science and Research, G.m.b.h.

Registry information

Official study title

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

Acronym: GLOCK-pilot

Important dates

Study start
2017
Primary completion
2017
Study completion
2018
First posted
Mar 24, 2017
Registry last updated
Jan 25, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.