GPur- Luminating Oral Cholesterol Kinetics Pilot Study | NCT03090542

Studies
GPur- Luminating Oral Cholesterol Kinetics Pilot Study

NCT03090542

Sponsor

Canadian Collaborative Research Network

Status

Completed

Last Update Posted

Jan 25, 2018Actual

Enrollment

22Actual

Phase

Not Applicable

Conditions

Cholesterol Absorption

Interventions

clinoptilolite

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 1, 2017Actual

Primary Completion Date

Nov 30, 2017Actual

Completion Date

Jan 15, 2018Actual

First Submitted Date

Mar 6, 2017

First Submission Date that Met QC Criteria

Mar 20, 2017

First Posted Date

Mar 24, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 23, 2018

Last Update Posted Date

Jan 25, 2018Actual

Name	Class
GLOCK HEALTH, Science and Research, G.m.b.h.	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

22Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Control	No Intervention
Product	Active Comparator		Dietary Supplement: clinoptilolite

Interventions

Name	Type	Description	Arm Group Labels	Other Names
clinoptilolite	Dietary Supplement	randomized, open-label, cross-over study of control vs clinoptilolite with a washout period separating the 2 phases	Product

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percent change in fractional cholesterol absorption in human subjects taking clinoptilolite over 6 days	Primary Objective	39 days

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Narendra Singh, MD	Canadian Collaborative Research Network	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Atlanta Heart Specialists		Cumming	Georgia	30041	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided