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

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

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.

Study Overview

• Status: Completed
• Conditions: Cholesterol Absorption
• Intervention / Treatment: Dietary supplement: clinoptilolite

• Study Type: Interventional
• Enrollment (Actual): 22
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Cumming, Georgia, United States, 30041
      • Atlanta Heart Specialists

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Canadian Collaborative Research Network
• Collaborators: GLOCK HEALTH, Science and Research, G.m.b.h.
• Investigators: Principal Investigator: Narendra Singh, MD, Canadian Collaborative Research Network

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2017
• Primary Completion (Actual): November 30, 2017
• Study Completion (Actual): January 15, 2018

Study Registration Dates

• First Submitted: March 6, 2017
• First Submitted That Met QC Criteria: March 20, 2017
• First Posted (Actual): March 24, 2017

Study Record Updates

• Last Update Posted (Actual): January 25, 2018
• Last Update Submitted That Met QC Criteria: January 23, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: GLOCK-Pilot 2017

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No