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
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...
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| Format: | Article |
| Language: | English |
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Frontiers Media S.A.
2021-03-01
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| Series: | Frontiers in Cardiovascular Medicine |
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| Online Access: | https://www.frontiersin.org/articles/10.3389/fcvm.2021.602086/full |
| _version_ | 1818700568362745856 |
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| author | Anouk Tanghe Anouk Tanghe Bert Celie Bert Celie Samyah Shadid Ernst Rietzschel Ernst Rietzschel Jos Op ‘t Roodt Koen D. Reesink Elsa Heyman Patrick Calders |
| author_facet | Anouk Tanghe Anouk Tanghe Bert Celie Bert Celie Samyah Shadid Ernst Rietzschel Ernst Rietzschel Jos Op ‘t Roodt Koen D. Reesink Elsa Heyman Patrick Calders |
| author_sort | Anouk Tanghe |
| collection | DOAJ |
| description | 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.Clinical Trial Registration:www.Clinicaltrials.gov, identifier: NCT03722199. |
| first_indexed | 2024-12-17T15:07:01Z |
| format | Article |
| id | doaj.art-70d67292780f479fa0f7f4ba09f7a341 |
| institution | Directory Open Access Journal |
| issn | 2297-055X |
| language | English |
| last_indexed | 2024-12-17T15:07:01Z |
| publishDate | 2021-03-01 |
| publisher | Frontiers Media S.A. |
| record_format | Article |
| series | Frontiers in Cardiovascular Medicine |
| spelling | doaj.art-70d67292780f479fa0f7f4ba09f7a3412022-12-21T21:43:46ZengFrontiers Media S.A.Frontiers in Cardiovascular Medicine2297-055X2021-03-01810.3389/fcvm.2021.602086602086Acute 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 TrialAnouk Tanghe0Anouk Tanghe1Bert Celie2Bert Celie3Samyah Shadid4Ernst Rietzschel5Ernst Rietzschel6Jos Op ‘t Roodt7Koen D. Reesink8Elsa Heyman9Patrick Calders10Department of Rehabilitation Sciences, Ghent University, Ghent, BelgiumUniv. Lille, Univ. Artois, Univ. Littoral Côte d'Opale, ULR 7369 - URePSSS - Unité de Recherche Pluridisciplinaire Sport Santé Société, Lille, FranceDepartment of Rehabilitation Sciences, Ghent University, Ghent, BelgiumFaculty of Health Sciences, Sport, Exercise Medicine and Lifestyle Institute (SEMLI), University of Pretoria, Pretoria, South AfricaDepartment of Endocrinology, Ghent University Hospital, Ghent, BelgiumDepartment of Cardiology, Ghent University Hospital, Ghent, BelgiumDepartment of Internal Medicine, Ghent University, Ghent, BelgiumSchool of Cardiovascular Diseases (CARIM), Maastricht University Medical Centre, Maastricht, NetherlandsSchool of Cardiovascular Diseases (CARIM), Maastricht University Medical Centre, Maastricht, NetherlandsUniv. Lille, Univ. Artois, Univ. Littoral Côte d'Opale, ULR 7369 - URePSSS - Unité de Recherche Pluridisciplinaire Sport Santé Société, Lille, FranceDepartment of Rehabilitation Sciences, Ghent University, Ghent, BelgiumIntroduction: 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.Clinical Trial Registration:www.Clinicaltrials.gov, identifier: NCT03722199.https://www.frontiersin.org/articles/10.3389/fcvm.2021.602086/fulltype 2 diabetescocoa flavanolsvascular reactivityblood pressuremuscular oxygenationantihypertensive drugs |
| spellingShingle | Anouk Tanghe Anouk Tanghe Bert Celie Bert Celie Samyah Shadid Ernst Rietzschel Ernst Rietzschel Jos Op ‘t Roodt Koen D. Reesink Elsa Heyman Patrick Calders 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 Frontiers in Cardiovascular Medicine type 2 diabetes cocoa flavanols vascular reactivity blood pressure muscular oxygenation antihypertensive drugs |
| title | 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 |
| title_full | 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 |
| title_fullStr | 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 |
| title_full_unstemmed | 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 |
| title_short | 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 |
| title_sort | 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 |
| topic | type 2 diabetes cocoa flavanols vascular reactivity blood pressure muscular oxygenation antihypertensive drugs |
| url | https://www.frontiersin.org/articles/10.3389/fcvm.2021.602086/full |
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