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| Name | Class |
|---|---|
| KGK Science Inc. | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Basis 250 | Experimental |
| |
| Basis 500 | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Basis 250 | Dietary Supplement |
| ||
| Basis 500 |
| Measure | Description | Time Frame |
|---|---|---|
| Blood pressure | Assessment of blood pressure | 8 weeks |
| Safety Blood Parameters | Assessment of safety blood parameters: CBC, electrolytes (Na, K, Cl), kidney function (creatinine), liver function (AST, ALT, GGT and bilirubin) | 8 weeks |
| Heart Rate | Assessment of heart rate | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Physiological Performance | 6 Minute Walk Test | 8 weeks |
| Physiological Performance | 30 Second Chair Stand Test | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Expression Profile of Peripheral Blood Mononuclear Cells | 8 weeks | |
| Pain Assessment | VAS Pain Scale | 8 weeks |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tetyana Pelipyagina, MD | KGK Science Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| KGK Synergize Inc. | London | Ontario | N6A 5R8 | Canada |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Mar 14, 2018 | |
| Reset | Oct 12, 2018 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Mar 14, 2018 | Oct 12, 2018 |
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|
| Placebo | Dietary Supplement |
|
| Physiological Performance | Physical Activity Scale for the Elderly | 8 weeks |
| Body Weight | 8 weeks |
| Blood Pressure | 8 weeks |
| Serum Glucose | 8 weeks |
| Lipid Profile | 8 weeks |
| Quality of Life and Sleep Quality | Health Assessment Questionnaire | 8 weeks |
| Quality of Life and Sleep Quality | Older People's Quality of Life Questionnaires | 8 weeks |
| Blood NAD+ | 8 weeks |
| Endothelial Function |
EndoPat |
| 8 weeks |