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

Primary Purpose

Microangiopathy, Diabetic, Polyphenol, Optical Tomography

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Cocoa flavanol
Placebo
Sponsored by
University of Surrey
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Microangiopathy, Diabetic

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • University of Surrey

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Other

Other

Other

Other

Arm Label

Healthy participants: Cocoa flavanol - Placebo

Healthy participant: Placebo - Cocoa flavanol

Type 2 diabetes participants: Cocoa flavanol - Placebo

Type 2 diabetes participants: Placebo - Cocoa flavanol

Arm Description

Healthy participants receiving cocoa flavanols on first study day and placebo on second study day

Healthy participants receiving placebo on first study day and cocoa flavanols on second study day

Participants with type 2 diabetes receiving cocoa flavanols on first study day and placebo on second study day

Participants with type 2 diabetes receiving placebo on first study day and cocoa flavanols on second study day

Outcomes

Primary Outcome Measures

Microvascular dilation
Microvascular diameter increase in response to 5 min limb occlusion on hands and feet
Macrovascular endothelial function
Flow-mediated dilation determined with ultrasound in brachial and common femoral artery

Secondary Outcome Measures

Arterial stiffness
Pulse wave velocity (Arteriograph)
Blood pressure
Upper arm blood pressure measured with Arteriograph
Leg perfusion pressure
Doppler based perfusion pressure of leg

Full Information

First Posted
May 18, 2021
Last Updated
July 4, 2022
Sponsor
University of Surrey
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1. Study Identification

Unique Protocol Identification Number
NCT05449782
Brief Title
Macro- and Microvascular Response to Cocoa Flavanols in Healthy and Type 2 Diabetes
Official Title
Proof-of-concept Study to Investigate Hand and Foot Microvascular Response to Cocoa Flavanols in Healthy and Type 2 Diabetes Participant
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
May 17, 2021 (Actual)
Primary Completion Date
June 1, 2021 (Actual)
Study Completion Date
May 17, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Surrey

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Microangiopathy, Diabetic, Polyphenol, Optical Tomography, Vascular Endothelium, Arterial Stiffness, Healthy Participants

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
2 group (healthy and type 2 diabetes) randomised controlled cross-over (2-period, 2-sequence) study
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
Placebo and cocoa flavanols will be delivered in same number of identical appearing capsules
Allocation
Randomized
Enrollment
22 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Healthy participants: Cocoa flavanol - Placebo
Arm Type
Other
Arm Description
Healthy participants receiving cocoa flavanols on first study day and placebo on second study day
Arm Title
Healthy participant: Placebo - Cocoa flavanol
Arm Type
Other
Arm Description
Healthy participants receiving placebo on first study day and cocoa flavanols on second study day
Arm Title
Type 2 diabetes participants: Cocoa flavanol - Placebo
Arm Type
Other
Arm Description
Participants with type 2 diabetes receiving cocoa flavanols on first study day and placebo on second study day
Arm Title
Type 2 diabetes participants: Placebo - Cocoa flavanol
Arm Type
Other
Arm Description
Participants with type 2 diabetes receiving placebo on first study day and cocoa flavanols on second study day
Intervention Type
Dietary Supplement
Intervention Name(s)
Cocoa flavanol
Intervention Description
Commercially available Cocoa Via Brand capsules containing 1350 mg cocoa flavanols (6 capsules)
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Capsules identical to ccocoa flavanol capsules filled with calorically matched brown sugar (6 capsules)
Primary Outcome Measure Information:
Title
Microvascular dilation
Description
Microvascular diameter increase in response to 5 min limb occlusion on hands and feet
Time Frame
Change at 2 hours as compared to baseline after ingestion of cocoa flavanol vs placebo
Title
Macrovascular endothelial function
Description
Flow-mediated dilation determined with ultrasound in brachial and common femoral artery
Time Frame
Change at 2 hours as compared to baseline after ingestion of cocoa flavanol vs placebo
Secondary Outcome Measure Information:
Title
Arterial stiffness
Description
Pulse wave velocity (Arteriograph)
Time Frame
Change at 2 hours as compared to baseline after ingestion of cocoa flavanol vs placebo
Title
Blood pressure
Description
Upper arm blood pressure measured with Arteriograph
Time Frame
Change at 2 hours as compared to baseline after ingestion of cocoa flavanol vs placebo
Title
Leg perfusion pressure
Description
Doppler based perfusion pressure of leg
Time Frame
Change at 2 hours as compared to baseline after ingestion of cocoa flavanol vs placebo
Other Pre-specified Outcome Measures:
Title
Photoplethysmography (PPG) based pulse wave velocity (PWV)
Description
PWV velocity calculated based on PPG sensor at hand and foot
Time Frame
Change at 2 hours as compared to baseline after ingestion of cocoa flavanol vs placebo
Title
Photoplethysmography (PPG) blood flow
Description
Based on PPG signals on hand and foot
Time Frame
Change at 2 hours as compared to baseline after ingestion of cocoa flavanol vs placebo

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christian Heiss, Prof.
Organizational Affiliation
University of Surrey, Department of Clinical and Experimental Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Surrey
City
Guildford
ZIP/Postal Code
GU2 7XH
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Will be decided on an individual basis and after study completion.

Learn more about this trial

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

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