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This is a mechanistic, single-center, double-blind, placebo- and active-controlled, three-time-period, crossover study to evaluate the effect of sprinkled format REDUCOSE compared to placebo (double-blind; confirmative) and active control (open-label; acarbose - explorative) on post prandial glycemia in Asian patients with type 2 diabetes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ARM A: Sprinkled Format REDUCOSE | Active Comparator | 2 G powder sprinkle containing 250 mg REDUCOSE (mulberry leaf extract - 250 mg - 5% DNJ) + fiber, vitamin D, and chromium picolinate |
|
| ARM B: Placebo B: Standard Meal | Placebo Comparator | A placebo matching to the test product will be used as control |
|
| ARM C: Placebo C: Acarbose | Placebo Comparator | Acarbose 100 mg tablet (provided in open-label format) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dietary Supplement: Sprinkled Format REDUCOSE. | Dietary Supplement | 2 G powder sprinkle containing 250 mg REDUCOSE (mulberry leaf extract - 250 mg - 5% DNJ) + fiber, vitamin D, and chromium picolinate |
| Measure | Description | Time Frame |
|---|---|---|
| Post-prandial glycemic excursion (ARMs A and B) | Incremental area under the curve post-prandial glycemic excursion (iAUC 0-1h, iAUC 0-2h, iAUC 0-3h). | 0 ,15, 30, 60, 120, and 180 minutes. |
| Measure | Description | Time Frame |
|---|---|---|
| 2h post-prandial glucose levels (ARMs A and B) | Incremental area under the curve 2h post-prandial glucose levels | 0 ,15, 30, 60, and 120 minutes. |
| Total glucose (All ARMS) | Total glucose AUC 0-1h (tAUC 0-1h, tAUC 0-2h, tAUC 0-3h) |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma glucose timepoints (ARMs A and B) | Plasma glucose at individual timepoints | 0 ,15, 30, 60, 120, and 180 minutes. |
| Serum insulin timepoints (ARMs A and B) | Serum insulin at individual timepoints |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Orange County Research Center | Tustin | California | 92780 | United States | ||
| Temasek Polytechnic |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36855010 | Derived | Mohamed M, Zagury RL, Bhaskaran K, Neutel J, Mohd Yusof BN, Mooney L, Yeo L, Kirwan BA, Aprikian O, von Eynatten M, Johansen OE. A Randomized, Placebo-Controlled Crossover Study to Evaluate Postprandial Glucometabolic Effects of Mulberry Leaf Extract, Vitamin D, Chromium, and Fiber in People with Type 2 Diabetes. Diabetes Ther. 2023 Apr;14(4):749-766. doi: 10.1007/s13300-023-01379-4. Epub 2023 Mar 1. |
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| Reference control | Other | A placebo matching to the test product will be used as control |
|
| Active comparator | Other | Acarbose 100 mg tablet (provided in open-label format) |
|
| 0 ,15, 30, 60, 120, and 180 minutes. |
| Plasma glucose iCmax (ARMs A and B) | Plasma glucose iCmax | 0 ,15, 30, 60, 120, and 180 minutes. |
| Plasma glucose Tmax (ARMs A and B) | Plasma glucose Tmax | 0 ,15, 30, 60, 120, and 180 minutes. |
| Plasma glucose AUC (ARMs A and B) | protocol states (iAUC 0-3h, tAUC 0-3h) | 0 ,15, 30, 60, 120, and 180 minutes. |
| Serum insulin (All ARMs) | Serum insulin (iAUC 0-3h, iCmax, Tmax, tAUC 0-3h) | 0 ,15, 30, 60, 120, and 180 minutes. |
| Plasma GLP-1 (ARMs A and B) | Plasma GLP-1 (iAUC 0-2h, iCmax, Tmax, tAUC 0-2h) | 0 ,15, 30, 60, 120, and 180 minutes. |
| Plasma GIP (ARMs A and B) | Plasma GIP (iAUC 0-2h, iCmax, Tmax, tAUC 0-2h) | 0 ,15, 30, 60, 120, and 180 minutes. |
| Plasma interleukin-6 (ARMs A and B) | Plasma interleukin-6 (IL-6) (iAUC 0-2h, iCmax, Tmax, tAUC 0-2h) | 0 ,15, 30, 60, 120, and 180 minutes. |
| Gastric emptying (ARMs A and B) | Gastric emptying (iAUC 0-1h, tAUC 0-1h, iAUC 0-3h, tAUC 0-3h, Cmax and Tmax for paracetamol) | 0 ,15, 30, 60, 120, and 180 minutes. |
| Matsuda Index (ARMs A and B) | Matsuda Index | 0, 30, 60, and 120 minutes. |
| 0 ,15, 30, 60, 120, and 180 minutes. |
| Plasma GIP and GLP-1 (ARMs A and B) | Plasma GIP and GLP-1 at individual timepoints | 0 ,15, 30, 60, 120, and 180 minutes. |
| Plasma IL-6 (ARMs A and B) | Plasma IL-6 at individual timepoints | 0 ,15, 30, 60, 120, and 180 minutes. |
| Plasma GLP-1 iAUC (ARMs A and B) | Plasma GLP-1 (iAUC 0-1h, tAUC 0-1h) | 0 ,15, 30, 60, 120, and 180 minutes. |
| Plasma GIP iAUC (ARMs A and B) | Plasma GIP (iAUC 0-1h, tAUC 0-1h) | 0 ,15, 30, 60, 120, and 180 minutes. |
| Plasma IL-6 iAUC (ARMs A and B) | Plasma IL-6 (iAUC 0-4h, tAUC 0-4h, iAUC 0-2h, tAUC 0-2h, iAUC 0-1h, tAUC 0-1h) | 0 ,15, 30, 60, 120, and 180 minutes. |
| Singapore |
| 529757 |
| Singapore |