Macro- and Microvascular Response to Cocoa Flavanols in Healthy and Type 2 Diabetes
NCT ID: NCT05449782
Last Updated: 2022-07-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
22 participants
INTERVENTIONAL
2021-05-17
2022-05-17
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
BASIC_SCIENCE
TRIPLE
Study Groups
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Healthy participants: Cocoa flavanol - Placebo
Healthy participants receiving cocoa flavanols on first study day and placebo on second study day
Cocoa flavanol
Commercially available Cocoa Via Brand capsules containing 1350 mg cocoa flavanols (6 capsules)
Placebo
Capsules identical to ccocoa flavanol capsules filled with calorically matched brown sugar (6 capsules)
Healthy participant: Placebo - Cocoa flavanol
Healthy participants receiving placebo on first study day and cocoa flavanols on second study day
Cocoa flavanol
Commercially available Cocoa Via Brand capsules containing 1350 mg cocoa flavanols (6 capsules)
Placebo
Capsules identical to ccocoa flavanol capsules filled with calorically matched brown sugar (6 capsules)
Type 2 diabetes participants: Cocoa flavanol - Placebo
Participants with type 2 diabetes receiving cocoa flavanols on first study day and placebo on second study day
Cocoa flavanol
Commercially available Cocoa Via Brand capsules containing 1350 mg cocoa flavanols (6 capsules)
Placebo
Capsules identical to ccocoa flavanol capsules filled with calorically matched brown sugar (6 capsules)
Type 2 diabetes participants: Placebo - Cocoa flavanol
Participants with type 2 diabetes receiving placebo on first study day and cocoa flavanols on second study day
Cocoa flavanol
Commercially available Cocoa Via Brand capsules containing 1350 mg cocoa flavanols (6 capsules)
Placebo
Capsules identical to ccocoa flavanol capsules filled with calorically matched brown sugar (6 capsules)
Interventions
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Cocoa flavanol
Commercially available Cocoa Via Brand capsules containing 1350 mg cocoa flavanols (6 capsules)
Placebo
Capsules identical to ccocoa flavanol capsules filled with calorically matched brown sugar (6 capsules)
Eligibility Criteria
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Inclusion Criteria
* BMI 20-30 kg/m\^2
* 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.
Type 2 Diabetes:
* 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.
20 Years
70 Years
ALL
Yes
Sponsors
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University of Surrey
OTHER
Responsible Party
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Principal Investigators
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Christian Heiss, Prof.
Role: PRINCIPAL_INVESTIGATOR
University of Surrey, Department of Clinical and Experimental Medicine
Locations
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University of Surrey
Guildford, , United Kingdom
Countries
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Other Identifiers
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OCTA2
Identifier Type: -
Identifier Source: org_study_id
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