Cholesterol AbsorptionGLOCK-pilotNCT03090542
GPur- Luminating Oral Cholesterol Kinetics Pilot Study
A study testing clinoptilolite in people with Cholesterol Absorption, run by Canadian Collaborative Research Network at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cholesterol Absorption
- What is being tested?
- clinoptilolite
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2017to 15 Jan 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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)
Show all 17Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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
- Being tested
- clinoptilolite
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
clinoptiloliteDietary supplement
randomized, open-label, cross-over study of control vs clinoptilolite with a washout period separating the 2 phases
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Not described |
| Product | Active comparator | Not described Receives: Dietary Supplement: clinoptilolite |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent change in fractional cholesterol absorption in human subjects taking clinoptilolite over 6 days
Primary Objective
Measured: 39 days
Secondary outcomes (2)
Percent change from baseline by gender to determine gender difference in fractional cholesterol absorption rates
Secondary Objective
Measured: 39 days
Percent change from baseline to end of treatment to evaluate for safety changes in metabolic profile measurements
Secondary Objective
Measured: 39 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2017
- Study start1 Jun 2017
- Primary completion30 Nov 2017
- Study completion15 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cholesterol AbsorptionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Canadian Collaborative Research Network
- Sponsor type
- University, hospital or other
- Collaborators
- GLOCK HEALTH, Science and Research, G.m.b.h.
- Responsible party
- Sponsor
- Investigators
- Narendra Singh, MD, Principal investigator, Canadian Collaborative Research Network
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03090542
- Sponsor's protocol ID
- GLOCK-Pilot 2017
- Acronym
- GLOCK-pilot
- Status last verified
- Jan 2018
- First submitted
- 6 Mar 2017
- Last updated
- 25 Jan 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03090542
- Acronym / sponsor ID
- GLOCK-pilot / GLOCK-Pilot 2017
- Conditions
- Cholesterol Absorption
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Canadian Collaborative Research NetworkUniversity, hospital or other
- Collaborators
- GLOCK HEALTH, Science and Research, G.m.b.h.
- Study start
- 1 Jun 2017 (actual)
- Primary completion
- 30 Nov 2017 (actual)
- Study completion
- 15 Jan 2018 (actual)
- First posted
- 24 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | – |
| Product | Active comparator | Dietary Supplement: clinoptilolite |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| clinoptiloliterandomized, open-label, cross-over study of control vs clinoptilolite with a washout period separating the 2 phases | Dietary supplement | Product |
Primary outcome
Percent change in fractional cholesterol absorption in human subjects taking clinoptilolite over 6 days
Time frame: 39 days
Primary Objective
2 secondary outcomes
Percent change from baseline by gender to determine gender difference in fractional cholesterol absorption rates
Time frame: 39 days
Percent change from baseline to end of treatment to evaluate for safety changes in metabolic profile measurements
Time frame: 39 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2018.
- Individual participant dataSharing planned: No
Related trials for Cholesterol Absorption
Not yet recruiting
GPR146 and Cholesterol Metabolism
Healthy Participants
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Narendra Singh, MD principal investigator
Canadian Collaborative Research Network
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing clinoptilolite in people with Cholesterol Absorption, run by Canadian Collaborative Research Network at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent change in fractional cholesterol absorption in human subjects taking clinoptilolite over 6 days (time frame: 39 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jan 2018.