GPur- Luminating Oral Cholesterol Kinetics Pilot Study

NCT03090542 | Completed DMC

• 1 other identifier: GLOCK-Pilot 2017
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Cholesterol Absorption

Outcome Measures

Primary Outcomes (1)

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

  Primary Objective

  39 days

Secondary Outcomes (2)

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

  39 days

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

  39 days

Study Arms (2)

Control

NO INTERVENTION

Product

ACTIVE COMPARATOR

Dietary Supplement: clinoptilolite

Interventions

clinoptilolite DIETARY_SUPPLEMENT

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

Product

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Canadian Collaborative Research Network: lead
• GLOCK HEALTH, Science and Research, G.m.b.h.: collaborator

Study Sites (1)

Atlanta Heart Specialists

Cumming, Georgia, 30041, United States

Location

MeSH Terms

Interventions

clinoptilolite

Study Officials

• Narendra Singh, MD

  Canadian Collaborative Research Network

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2017
• First Posted: March 24, 2017
• Study Start: June 1, 2017
• Primary Completion: November 30, 2017
• Study Completion: January 15, 2018
• Last Updated: January 25, 2018

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)