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The greatest challenge in our ageing society are cardiovascular diseases such as stroke, heart attack, peripheral artery disease of the legs with non-healing wounds (ulcers), or diabetes. Specific diets with high polyphenol content are associated with lower incidence of cardiovascular disease and can improve macrovascular function when consumed acutely and chronically. Which role the smallest blood vessels (microcirculation) play in this and if the microcirculation responds to therapies is not well understood. One reason for this is that no generally available medical instrument has the resolution to study the microcirculation. The recently developed optical coherence tomography angiography (OCTA), currently mainly used by eye doctors, is able to visualise the microcirculation.
The current randomised controlled cross-over proof-of-concept study will test the acute effect of a cocoa flavanol intervention on cutaneous microvascular structure and function of hands and feet together with macrovascular function of upper and lower extremities in healthy and type 2 diabetes participants. It is the hypothesis that cocoa flavanol intervention as compared to placebo can acutely increase microvascular vasodilation and macrovascular endothelial function in arms and legs together with arterial stiffness in both healthy and type 2 diabetes participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healthy participants: Cocoa flavanol - Placebo | Other | Healthy participants receiving cocoa flavanols on first study day and placebo on second study day |
|
| Healthy participant: Placebo - Cocoa flavanol | Other | Healthy participants receiving placebo on first study day and cocoa flavanols on second study day |
|
| Type 2 diabetes participants: Cocoa flavanol - Placebo | Other | Participants with type 2 diabetes receiving cocoa flavanols on first study day and placebo on second study day |
|
| Type 2 diabetes participants: Placebo - Cocoa flavanol | Other | Participants with type 2 diabetes receiving placebo on first study day and cocoa flavanols on second study day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cocoa flavanol | Dietary Supplement | Commercially available Cocoa Via Brand capsules containing 1350 mg cocoa flavanols (6 capsules) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Microvascular dilation | Microvascular diameter increase in response to 5 min limb occlusion on hands and feet | Change at 2 hours as compared to baseline after ingestion of cocoa flavanol vs placebo |
| Macrovascular endothelial function | Flow-mediated dilation determined with ultrasound in brachial and common femoral artery | Change at 2 hours as compared to baseline after ingestion of cocoa flavanol vs placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Arterial stiffness | Pulse wave velocity (Arteriograph) | Change at 2 hours as compared to baseline after ingestion of cocoa flavanol vs placebo |
| Blood pressure | Upper arm blood pressure measured with Arteriograph |
| Measure | Description | Time Frame |
|---|---|---|
| Photoplethysmography (PPG) based pulse wave velocity (PWV) | PWV velocity calculated based on PPG sensor at hand and foot | Change at 2 hours as compared to baseline after ingestion of cocoa flavanol vs placebo |
| Photoplethysmography (PPG) blood flow |
Healthy:
Inclusion Criteria:
Exclusion Criteria:
Type 2 Diabetes:
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christian Heiss, Prof. | University of Surrey, Department of Clinical and Experimental Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Surrey | Guildford | GU2 7XH | United Kingdom |
Will be decided on an individual basis and after study completion.
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| ID | Term |
|---|---|
| D003925 | Diabetic Angiopathies |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
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2 group (healthy and type 2 diabetes) randomised controlled cross-over (2-period, 2-sequence) study
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Placebo and cocoa flavanols will be delivered in same number of identical appearing capsules
| Placebo | Other | Capsules identical to ccocoa flavanol capsules filled with calorically matched brown sugar (6 capsules) |
|
| Change at 2 hours as compared to baseline after ingestion of cocoa flavanol vs placebo |
| Leg perfusion pressure | Doppler based perfusion pressure of leg | Change at 2 hours as compared to baseline after ingestion of cocoa flavanol vs placebo |
Based on PPG signals on hand and foot
| Change at 2 hours as compared to baseline after ingestion of cocoa flavanol vs placebo |
| D004700 |
| Endocrine System Diseases |