An interventional study of Carbonated water with amino acids and chromium and Placebo Carbonated Water in Postprandial Hyperglycemia, Metabolic Syndrome and Type 2 Diabetes Mellitus, sponsored by DoubleGood AB. Completed at 1 site in Sweden. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-09-04.
Sponsored by DoubleGood AB · Not applicable, Interventional, and Prevention
It has previously been shown in healthy subjects, that a carbonated water containing a mix of amino acids and chromium picolinate can decrease postprandial blood glucose. Based on these findings, a flavored sparkling water product called Good Idea® with a proprietary blend of five amino acids and chromium picolinate has been developed. This product, along with an identical placebo, are included in this study to evaluate the effects on postprandial blood glucose in healthy, overweight adults when consumed with a standardized, high glycemic test meal. The study will be conducted in a cross-over design, double-blinded and placebo controlled, including 45 participants. The primary endpoint of the study is the incremental area under the curve (iAUC) for capillary blood glucose within 180 minutes after ingestion of the meal.
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This study's enrollment of 44 is below the median of 80 across 7,525 interventional studies indexed under Diabetes Mellitus, Type 2.
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Exclusion Criteria:
The carbonated water with a proprietary blend of five amino acids and chromium picolinate is consumed with a standardized test meal to study its effects on glucose and insulin responses.
Dietary Supplement: Carbonated water with amino acids and chromium
The placebo carbonated water is consumed with a standardized test meal to study its effects on glucose and insulin responses.
Dietary Supplement: Placebo Carbonated Water
The active carbonated water containing amino acids and chromium picolinate is consumed with a standardized test meal. Postprandial glucose and insulin response is documented for 180 minutes
The placebo carbonated water is consumed with a standardized test meal. Postprandial glucose and insulin response is documented for 180 minutes
The three-hour incremental area under the curve (iAUC) for capillary blood glucose, 0-180 minutes
The incremental area under the curve for capillary blood glucose will be measured within 180 minutes after a test meal. Blood samples will be collected at 8 time points during the 180 minutes.
Time frame: 0, 15, 30, 45, 60, 90, 120 and 180 minutes post test meal
The three-hour iAUC for insulin, 0-180 minutes
The incremental area under the curve for intravenous blood insulin will be measured within 180 minutes after a test meal. Blood samples will be collected at 8 time points during the 180 minutes.
Time frame: 0, 15, 30, 45, 60, 90, 120 and 180 minutes post test meal
The three hour iAUC for intravenous glucose, 0-180 minutes
The incremental area under the curve for intravenous blood glucose will be measured within 180 minutes after a test meal. Blood samples will be collected at 8 time points during the 180 minutes.
Time frame: 0, 15, 30, 45, 60, 90, 120 and 180 minutes post test meal
The one-hour iAUC for intravenous Glucagon-like peptide 1 (GLP-1), 0-60 minutes
The incremental area under the curve for intravenous blood GLP-1 will be measured within 60 minutes after a test meal. Blood samples will be collected at 5 time points during the 60 minutes.
Time frame: 0, 15, 30, 45 and 60 minutes post test meal
The three-hour Cmax of capillary blood glucose, venous blood glucose and venous blood insulin
Blood samples will be collected at 8 time points during the 180 minutes.
Time frame: 0, 15, 30, 45, 60, 90, 120 and 180 minutes post test meal
The Tmax (time to maximum concentration) of capillary blood glucose, venous blood glucose and venous blood insulin
Blood samples will be collected at 8 time points during the 180 minutes.
Time frame: 0, 15, 30, 45, 60, 90, 120 and 180 minutes post test meal
The two-hour iAUC for capillary blood glucose, venous blood glucose and venous blood insulin
Blood samples will be collected at 7 time points during the 120 minutes.
Time frame: 0, 15, 30, 45, 60, 90 and 120 minutes post test meal
The one-hour iAUC for capillary blood glucose, venous blood glucose and venous blood insulin
Blood samples will be collected at 5 time points during the 60 minutes.
Time frame: 0, 15, 30, 45 and 60 minutes post test meal
Difference in one-hour glucose (delta-glucose at 1h) from both capillary and intravenous blood.
A delta value will be calculated from samples collected at time=0 and time=60 minutes
Time frame: 0 and 60 minutes post test meal
Difference in two-hour glucose (delta-glucose at 2h) from both capillary and intravenous blood.
A delta value will be calculated from samples collected at time=0 and time=120 minutes
Time frame: 0 and 120 minutes post test meal
Plan to share: No
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This study is completed, as verified in Sep 2019. You cannot join it, but the record below documents what was studied.
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