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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
60
Active product. Amount: 355mL. Consumed at a clinic visit over 14 minutes.
Non-active placebo product. Amount: 355mL. Consumed at a clinic visit over 14 minutes.
KGK Synergize Inc.
London, Ontario, Canada
The difference of the two-hour iAUC (0 - 120 min) for intravenous blood glucose between Good IdeaTM and the placebo following a standardized meal.
Time frame: 0 - 120 minutes
The difference of the two-hour iAUC (0 - 120 min) for capillary blood glucose between Good IdeaTM and the placebo following a standardized meal.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 0 - 180 minutes
Eating patterns as assessed by a 3-day food record for the weeks prior to days 0 and 8.
Time frame: 1 week each
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