Acute Effects of Cocoa Flavanols on Blood Pressure and Peripheral Vascular Reactivity in Type 2 Diabetes Mellitus and Essential Hypertension: A Protocol for an Acute, Randomized, Double-Blinded, Placebo-Controlled Cross-Over Trial

Anouk Tanghe, Bert Celie, Samyah Shadid, Ernst Rietzschel, Jos Op't Roodt, Koen D. Reesink, Elsa Heyman, Patrick Calders*

*Corresponding author for this work

Research output: Contribution to journalArticleAcademicpeer-review

2 Citations (Web of Science)

Abstract

Introduction: Patients with type 2 diabetes mellitus are at high risk to develop vascular complications resulting in high morbidity and mortality. Cocoa flavanols are promising nutraceuticals with possible beneficial vascular effects in humans. However, limited research is currently available on the vascular effects in a diabetic population with inconsistent results. Possible reasons for this inconsistency might be heterogeneity in the given intervention (dose per time and day, single dose vs. split-dose, placebo formula) and the studied population (blood pressure at baseline, duration of diabetes, use of vasoactive antihypertensive and antidiabetic drugs, sex). Therefore, we aimed to develop a randomized, double-blinded, placebo-controlled cross-over trial to investigate whether cocoa flavanols have an acute impact on blood pressure and vascular reactivity in patients with type 2 diabetes with and without arterial hypertension.

Methods and Analysis: We will include participants in four groups: (i) patients with type 2 diabetes without arterial hypertension, (ii) patients with type 2 diabetes with arterial hypertension and 1 antihypertensive drug, (iii) non-diabetic participants with essential hypertension and 1 antihypertensive drug, and (iv) healthy controls. All participants will complete the same protocol on both testing days, consuming high-flavanol cocoa extract (790 mg flavanols) or placebo. Macrovascular endothelial function (flow-mediated dilation) and blood pressure will be measured before and after capsule ingestion. Forearm muscle vasoreactivity (near-infrared spectroscopy) and brachial artery blood flow (echo-doppler) will be assessed in response to a dynamic handgrip exercise test after capsule ingestion. Data will be analyzed with a random intercept model in mixed models.

Original languageEnglish
Article number602086
Number of pages11
JournalFrontiers in cardiovascular medicine
Volume8
DOIs
Publication statusPublished - 15 Mar 2021

Keywords

  • antihypertensive drugs
  • blood pressure
  • cocoa flavanols
  • muscular oxygenation
  • type 2 diabetes
  • vascular reactivity
  • OXIDATIVE STRESS
  • INFRARED SPECTROSCOPY NIRS
  • RICH COCOA
  • DARK CHOCOLATE
  • ENDOTHELIAL FUNCTION
  • BRACHIAL-ARTERY
  • FLOW-MEDIATED VASODILATION
  • INSULIN-RESISTANCE
  • NITRIC-OXIDE
  • HDL CHOLESTEROL

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