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| Name | Class |
|---|---|
| KGK Science Inc. | INDUSTRY |
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A crossover design to evaluate the safety and efficacy of GoodIdea TM (trademark) on glucose homeostasis in a healthy population. Eligible participants will be given either the GoodIdea drink or placebo and a standardized meal and will consume both in approximately 15 minutes. Blood will be drawn at several time points over a 3 hour period to determine the study objectives. After a 7-day washout, the participants will come back to the clinic and and complete the visit consuming the opposite product given at the previous visit. The primary objective is to see the difference of the two-hour iAUC for intravenous blood glucose between the active product (GoodIdea) and the placebo following a standardized meal.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Consume GoodIdea at Visit 2 and Placebo at Visit 3 | Experimental |
| |
| Consume Placebo at Visit 2 and GoodIdea at Visit 3 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GoodIdea | Dietary Supplement | Active product. Amount: 355mL. Consumed at a clinic visit over 14 minutes. |
|
| Measure | Description | Time Frame |
|---|---|---|
| The difference of the two-hour iAUC (0 - 120 min) for intravenous blood glucose between Good IdeaTM and the placebo following a standardized meal. | 0 - 120 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| The difference of the two-hour iAUC (0 - 120 min) for capillary blood glucose between Good IdeaTM and the placebo following a standardized meal. | 0 -120 minutes | |
| The difference in the two-hour Cmax, (0 - 120 min) of capillary glucose between Good IdeaTM and the placebo following a standardized meal. |
| Measure | Description | Time Frame |
|---|---|---|
| The effects of supplementation with Good IdeaTM on vital signs (blood pressure) compared to placebo | 180 minutes | |
| The effects of supplementation with Good IdeaTM on vital signs (heart rate) compared to placebo | 180 minutes |
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 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32579549 | Result | Ostman E, Samigullin A, Heyman-Linden L, Andersson K, Bjorck I, Oste R, Humpert PM. A novel nutritional supplement containing amino acids and chromium decreases postprandial glucose response in a randomized, double-blind, placebo-controlled study. PLoS One. 2020 Jun 24;15(6):e0234237. doi: 10.1371/journal.pone.0234237. eCollection 2020. |
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| Placebo | Other | Non-active placebo product. Amount: 355mL. Consumed at a clinic visit over 14 minutes. |
|
| 0 - 120 minutes |
| The difference in the two-hour Tmax (0 - 120 min) of capillary glucose between Good IdeaTM and the placebo following a standardized meal. | 0 - 120 minutes |
| The difference in the two-hour iAUC (0 - 120 min) intravenous insulin iAUC between Good IdeaTM and the placebo following a standardized meal. | 0 - 120 minutes |
| The difference in the two-hour Cmax (0 - 120 min) of intravenous glucose and insulin between Good IdeaTM and the placebo following a standardized meal. | 0 - 120 minutes |
| The difference in the two-hour Tmax (0 - 120 min) of intravenous glucose and insulin between Good IdeaTM and the placebo following a standardized meal. | 0 - 120 minutes |
| The difference in the three-hour iAUC (0 - 180 min) for intravenous blood glucose and insulin between Good IdeaTM and the placebo following a standardized meal. | 0 - 180 minutes |
| The difference in the three-hour Cmax (0 - 180 min) of intravenous glucose and insulin between Good IdeaTM and the placebo following a standardized meal. | 0 - 180 minutes |
| The difference in the three-hour Tmax (0 - 180 min) of intravenous glucose and insulin between Good IdeaTM and the placebo following a standardized meal. | 0 - 180 minutes |
| The difference in the three-hour iAUC (0 - 180 min) of capillary glucose between Good IdeaTM and the placebo following a standardized meal. | 0 - 180 minutes |
| The difference in the three-hour (0 - 180 min) Tmax of capillary glucose between Good IdeaTM and the placebo following a standardized meal. | 0 - 180 minutes |
| The difference in the three-hour (0 - 180 min) Cmax, of capillary glucose between Good IdeaTM and the placebo following a standardized meal. | 0 - 180 minutes |
| Eating patterns as assessed by a 3-day food record for the weeks prior to days 0 and 8. | 1 week each |
| The change in Hematology from screening to end-of-study between Good IdeaTM and the placebo | 21 - 42 days |
| The change in Clinical chemistry from screening to end-of-study between Good IdeaTM and the placebo | 21-42 days |
| Incidence of adverse events in the Good IdeaTM and placebo group over the course of the study. | 8-14 days |