Macro- and Microvascular Response to Cocoa Flavanols in Healthy and Type 2 Diabetes

Healthy Participants Clinical Trial

Official title:

Proof-of-concept Study to Investigate Hand and Foot Microvascular Response to Cocoa Flavanols in Healthy and Type 2 Diabetes Participant

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05449782
• Other study ID #: OCTA2
• Status: Completed
• Phase: N/A
• Start date: May 17, 2021
• Est. completion date: May 17, 2022

Study information

• Verified date: May 2022
• Source: University of Surrey
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: May 17, 2022
• Est. primary completion date: June 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 70 Years

Eligibility

Healthy:

Inclusion Criteria:

• Healthy, 20-70 years

• BMI 20-30 kg/m^2

Exclusion Criteria:

• Diabetes mellitus

• Symptoms of acute infection

• Cardiac rhythm other than sinus

• Active malignancy

• Clinical signs or symptoms of cardiovascular disease (coronary artery disease, lower extremity artery disease, cerebrovascular disease): angina pectoris, dyspnea, palpitation, syncope, claudication

• Active vasoactive medication.

Type 2 Diabetes:

Inclusion Criteria:

• Type 2 diabetes mellitus

• 20-70 years

• BMI 20-30 kg/m^2

Exclusion Criteria:

• Symptoms of acute infection

• Cardiac rhythm other than sinus

• Active malignancy

• Clinical signs or symptoms of cardiovascular disease (coronary artery disease, lower extremity artery disease, cerebrovascular disease): angina pectoris, dyspnea, palpitation, syncope, claudication

• Active vasoactive medication.

Related Conditions & MeSH terms

• Arterial Stiffness
• Diabetic Angiopathies
• Healthy Participants
• Optical Tomography
• Polyphenol
• Vascular Endothelium

Intervention

Dietary Supplement:
• Cocoa flavanol
Commercially available Cocoa Via Brand capsules containing 1350 mg cocoa flavanols (6 capsules)

Other:
• Placebo
Capsules identical to ccocoa flavanol capsules filled with calorically matched brown sugar (6 capsules)

Locations

Country	Name	City	State
United Kingdom	University of Surrey	Guildford

Sponsors (1)

Lead Sponsor	Collaborator
University of Surrey

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	Photoplethysmography (PPG) blood flow	Based on PPG signals on hand and foot	Change at 2 hours as compared to baseline after ingestion of cocoa flavanol vs placebo
Primary	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
Primary	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
Secondary	Arterial stiffness	Pulse wave velocity (Arteriograph)	Change at 2 hours as compared to baseline after ingestion of cocoa flavanol vs placebo
Secondary	Blood pressure	Upper arm blood pressure measured with Arteriograph	Change at 2 hours as compared to baseline after ingestion of cocoa flavanol vs placebo
Secondary	Leg perfusion pressure	Doppler based perfusion pressure of leg	Change at 2 hours as compared to baseline after ingestion of cocoa flavanol vs placebo