A Study to Evaluate Safety and Health Benefits of Basis™ Among Elderly Subjects. (15BSHE)
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT02678611 |
Recruitment Status :
Completed
First Posted : February 10, 2016
Last Update Posted : August 1, 2016
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Sponsor:
Elysium Health
Collaborator:
KGK Science Inc.
Information provided by (Responsible Party):
Elysium Health
Tracking Information | ||||
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First Submitted Date ICMJE | February 3, 2016 | |||
First Posted Date ICMJE | February 10, 2016 | |||
Last Update Posted Date | August 1, 2016 | |||
Study Start Date ICMJE | January 2016 | |||
Actual Primary Completion Date | July 2016 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE | Same as current | |||
Change History | ||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | |||
Current Other Pre-specified Outcome Measures |
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Original Other Pre-specified Outcome Measures | Same as current | |||
Descriptive Information | ||||
Brief Title ICMJE | A Study to Evaluate Safety and Health Benefits of Basis™ Among Elderly Subjects. | |||
Official Title ICMJE | A Randomized, Double-blind, Placebo Controlled Study to Evaluate Safety and Health Benefits of Basis™ Among Elderly Subjects. | |||
Brief Summary | This study will investigate the safety, tolerability and potential health benefits of the dietary supplement, Basis. There will be two doses of Basis compared to a placebo. One third of subjects will receive the low dose Basis, one third will receive the higher dose Basis and one third will receive placebo. | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 1 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
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Condition ICMJE | Safety: Healthy Subjects | |||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
120 | |||
Original Estimated Enrollment ICMJE | Same as current | |||
Study Completion Date ICMJE | Not Provided | |||
Actual Primary Completion Date | July 2016 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 60 Years to 80 Years (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | Yes | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Canada | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT02678611 | |||
Other Study ID Numbers ICMJE | 15BSHE | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Current Responsible Party | Elysium Health | |||
Original Responsible Party | Same as current | |||
Current Study Sponsor ICMJE | Elysium Health | |||
Original Study Sponsor ICMJE | Same as current | |||
Collaborators ICMJE | KGK Science Inc. | |||
Investigators ICMJE |
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PRS Account | Elysium Health | |||
Verification Date | July 2016 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |