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

NCT05449782 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2022-07-08

No results posted yet for this study

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.

Conditions

  • Microangiopathy, Diabetic
  • Polyphenol
  • Optical Tomography
  • Vascular Endothelium
  • Arterial Stiffness
  • Healthy Participants

Interventions

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)

Sponsors & Collaborators

  • University of Surrey

    lead OTHER

Principal Investigators

  • Christian Heiss, Prof. · University of Surrey, Department of Clinical and Experimental Medicine

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
20 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-05-17
Primary Completion
2021-06-01
Completion
2022-05-17

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05449782 on ClinicalTrials.gov