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Trial record 2 of 239763 for:    ALL

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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified March 2017 by Canadian Collaborative Research Network
Sponsor:
Collaborator:
Glock Health, Science and Research, Gmbh
Information provided by (Responsible Party):
Canadian Collaborative Research Network
ClinicalTrials.gov Identifier:
NCT03090542
First received: March 6, 2017
Last updated: March 20, 2017
Last verified: March 2017
  Purpose
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 Intervention
Cholesterol Absorption
Dietary Supplement: clinoptilolite

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: No masking
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

Resource links provided by NLM:


Further study details as provided by Canadian Collaborative Research Network:

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


Secondary Outcome Measures:
  • Percent change from baseline by gender to determine gender difference in fractional cholesterol absorption rates [ Time Frame: 39 days ]
    Secondary Objective

  • Percent change from baseline to end of treatment to evaluate for safety changes in metabolic profile measurements [ Time Frame: 39 days ]
    Secondary Objective


Estimated Enrollment: 22
Anticipated Study Start Date: May 15, 2017
Estimated Study Completion Date: December 15, 2017
Estimated Primary Completion Date: September 15, 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03090542

Contacts
Contact: Michelle Tsigoulis 9054538885 ext 428 mtsigoulis@ccrnmd.com
Contact: Mahesh Kajil 9054538885 ext 414 mkajil@ccrnmd.com

Sponsors and Collaborators
Canadian Collaborative Research Network
Glock Health, Science and Research, Gmbh
Investigators
Principal Investigator: Narendra Singh, MD Canadian Collaborative Research Network
  More Information

Responsible Party: Canadian Collaborative Research Network
ClinicalTrials.gov Identifier: NCT03090542     History of Changes
Other Study ID Numbers: GLOCK-Pilot 2017
Study First Received: March 6, 2017
Last Updated: March 20, 2017
Individual Participant Data  
Plan to Share IPD: No

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

ClinicalTrials.gov processed this record on March 24, 2017