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

NCT05449782 | Completed

• 1 other identifier: OCTA2
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (3)

• Arterial stiffness

  Change at 2 hours as compared to baseline after ingestion of cocoa flavanol vs placebo

• Blood pressure

  Change at 2 hours as compared to baseline after ingestion of cocoa flavanol vs placebo

• Leg perfusion pressure

  Change at 2 hours as compared to baseline after ingestion of cocoa flavanol vs placebo

Other Outcomes (2)

• Photoplethysmography (PPG) based pulse wave velocity (PWV)

  Change at 2 hours as compared to baseline after ingestion of cocoa flavanol vs placebo

• Photoplethysmography (PPG) blood flow

  Change at 2 hours as compared to baseline after ingestion of cocoa flavanol vs placebo

Study Arms (4)

Healthy participants: Cocoa flavanol - Placebo

OTHER

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

Dietary Supplement: Cocoa flavanol; Other: Placebo

Healthy participant: Placebo - Cocoa flavanol

OTHER

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

Dietary Supplement: Cocoa flavanol; Other: Placebo

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

Dietary Supplement: Cocoa flavanol; Other: Placebo

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

Dietary Supplement: Cocoa flavanol; Other: Placebo

Interventions

Cocoa flavanol DIETARY_SUPPLEMENT

Commercially available Cocoa Via Brand capsules containing 1350 mg cocoa flavanols (6 capsules)

Healthy participant: Placebo - Cocoa flavanol; Healthy participants: Cocoa flavanol - Placebo; Type 2 diabetes participants: Cocoa flavanol - Placebo; Type 2 diabetes participants: Placebo - Cocoa flavanol

Placebo OTHER

Capsules identical to ccocoa flavanol capsules filled with calorically matched brown sugar (6 capsules)

Healthy participant: Placebo - Cocoa flavanol; Healthy participants: Cocoa flavanol - Placebo; Type 2 diabetes participants: Cocoa flavanol - Placebo; Type 2 diabetes participants: Placebo - Cocoa flavanol

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy, 20-70 years
• BMI 20-30 kg/m\^2

You may not qualify if:

• 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:
• Type 2 diabetes mellitus
• years
• BMI 20-30 kg/m\^2
• 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.

Sponsors & Collaborators

• University of Surrey: lead

Study Sites (1)

University of Surrey

Guildford, GU2 7XH, United Kingdom

Location

MeSH Terms

Conditions

Diabetic Angiopathies

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases

Study Officials

• Christian Heiss, Prof.

  University of Surrey, Department of Clinical and Experimental Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Placebo and cocoa flavanols will be delivered in same number of identical appearing capsules
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 2 group (healthy and type 2 diabetes) randomised controlled cross-over (2-period, 2-sequence) study

Study Record Dates

• First Submitted: May 18, 2021
• First Posted: July 8, 2022
• Study Start: May 17, 2021
• Primary Completion: June 1, 2021
• Study Completion: May 17, 2022
• Last Updated: July 8, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)