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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03090542
Recruitment Status : Completed
First Posted : March 24, 2017
Last Update Posted : January 25, 2018
Sponsor:
Collaborator:
GLOCK HEALTH, Science and Research, G.m.b.h.
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Cholesterol Absorption Dietary Supplement: clinoptilolite Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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
Actual Study Start Date : June 1, 2017
Actual Primary Completion Date : November 30, 2017
Actual Study Completion Date : January 15, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: Control
Active Comparator: Product Dietary Supplement: clinoptilolite
randomized, open-label, cross-over study of control vs clinoptilolite with a washout period separating the 2 phases




Primary Outcome Measures :
  1. Percent change in fractional cholesterol absorption in human subjects taking clinoptilolite over 6 days [ Time Frame: 39 days ]
    Primary Objective


Secondary Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03090542


Locations
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United States, Georgia
Atlanta Heart Specialists
Cumming, Georgia, United States, 30041
Sponsors and Collaborators
Canadian Collaborative Research Network
GLOCK HEALTH, Science and Research, G.m.b.h.
Investigators
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Principal Investigator: Narendra Singh, MD Canadian Collaborative Research Network

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Responsible Party: Canadian Collaborative Research Network
ClinicalTrials.gov Identifier: NCT03090542     History of Changes
Other Study ID Numbers: GLOCK-Pilot 2017
First Posted: March 24, 2017    Key Record Dates
Last Update Posted: January 25, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No