Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Primary |
Change in macrovascular endothelial function in the fasted condition |
Macrovascular endothelial function will be measured using brachial artery flow mediated dilation (ultrasonography) during reactive hyperemia at baseline and after 4 weeks of supplementation. |
4 weeks |
|
Primary |
Change in macrovascular endothelial function during acute hyperglycemia |
Macrovascular endothelial function will be measured using brachial artery flow mediated dilation (ultrasonography) during reactive hyperemia at 60 minutes after oral glucose ingestion at baseline and after 4 weeks of supplementation. |
4 weeks |
|
Primary |
Change in microvascular endothelial function in the fasted condition |
Microvascular endothelial function will be assessed using peripheral arterial tonometry (EndoPAT device) during reactive hyperemia at baseline and after 4 weeks of supplementation. |
4 weeks |
|
Primary |
Change in microvascular endothelial function in the fasted condition |
Microvascular endothelial function will be assessed using forearm muscle oxygenation (near-infrared spectroscopy) during reactive hyperemia at baseline and after 4 weeks of supplementation. |
4 weeks |
|
Primary |
Change in microvascular endothelial function during acute hyperglycemia |
Microvascular endothelial function will be assessed using forearm muscle oxygenation (near-infrared spectroscopy) during reactive hyperemia at 60 minutes after oral glucose ingestion at baseline and after 4 weeks of supplementation. |
4 weeks |
|
Primary |
Change in blood glucose levels in the fasted condition |
Blood glucose levels will be measured by finger prick at baseline and after 4 weeks of supplementation. |
4 weeks |
|
Primary |
Change in blood glucose levels during acute hyperglycemia |
Blood glucose levels will be measured by finger prick at 60 minutes after oral glucose ingestion at baseline and after 4 weeks of supplementation. |
4 weeks |
|
Primary |
Change in central and peripheral arterial stiffness in the fasted condition |
Arterial stiffness will be assessed using the central (carotid-femoral) and peripheral (femoral-ankle) pulse wave velocity at baseline and after 4 weeks of supplementation. |
4 weeks |
|
Primary |
Change in central and peripheral arterial stiffness during acute hyperglycemia |
Arterial stiffness will be assessed using the central (carotid-femoral) and peripheral (femoral-ankle) pulse wave velocity at 60 minutes after oral glucose ingestion at baseline and after 4 weeks of supplementation. |
4 weeks |
|
Primary |
Change in blood pressure in the fasted condition |
Brachial and aortic blood pressure will be measured using an automated sphygmomanometry arm cuff (SphygmoCor XCEL). Beat-to-beat blood pressure will be measured using an automated photoplethysmography finger cuff (Finometer). Blood pressure will be measured at baseline and after 4 weeks of supplementation. |
4 weeks |
|
Primary |
Change in blood pressure during acute hyperglycemia |
Brachial and aortic blood pressure will be measured using an automated sphygmomanometry arm cuff (SphygmoCor XCEL). Beat-to-beat blood pressure will be measured using an automated photoplethysmography finger cuff (Finometer). Blood pressure will be measured at 60 minutes after oral glucose ingestion at baseline and after 4 weeks of supplementation. |
4 weeks |
|
Primary |
Change in stroke volume in the fasted condition |
Stroke volume will be measured using impedance cardiography (PhysioFlow) at baseline and after 4 weeks of supplementation. |
4 weeks |
|
Primary |
Change in stroke volume during acute hyperglycemia |
Stroke volume will be measured using impedance cardiography (PhysioFlow) at 60 minutes after oral glucose ingestion at baseline and after 4 weeks of supplementation. |
4 weeks |
|
Primary |
Change in total peripheral resistance in the fasted condition |
Total peripheral resistance will be measured using impedance cardiography (PhysioFlow) at baseline and after 4 weeks of supplementation. |
4 weeks |
|
Primary |
Change in total peripheral resistance during acute hyperglycemia |
Total peripheral resistance will be measured using impedance cardiography (PhysioFlow) at 60 minutes after oral glucose ingestion at baseline and after 4 weeks of supplementation. |
4 weeks |
|
Secondary |
Change in body composition |
Body composition (fat and lean mass) will be measured at baseline and after 4 weeks of supplementation. |
4 weeks |
|
Secondary |
Change in muscle strength |
Maximal handgrip strength will be measured using handgrip dynamometer. Leg extension and plantar flexion strength will be measured using the 10RM test at baseline and after 4 weeks of supplementation. |
4 weeks |
|
Secondary |
Change in insulin levels |
Serum insulin levels will be tested at baseline and after 4 weeks of supplementation. |
4 weeks |
|
Secondary |
Change in serum arginine levels |
Serum arginine levels will tested at baseline and after 4 weeks of supplementation. |
4 weeks |
|
Secondary |
Change in serum arginase activity levels |
Serum arginase activity levels will tested at baseline and after 4 weeks of supplementation. |
4 weeks |
|
Secondary |
Change in 24-hour ambulatory blood pressure monitoring |
Ambulatory blood pressure will be obtained using a monitor during daytime and nighttime on two separate days at baseline and after 4 weeks of supplementation. |
4 weeks |
|