Effects of Flavanoids in Essential Hypertension, Type 2 Diabetes and Healthy Persons

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

43 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-09-01

Study Completion Date

2021-03-20

Brief Summary

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Flavanols are natural substances who are frequently found in our nutrition. A lot of research has already been executed in the past to investigate what effects this flavanols could have in the human population. Based on these examinations, the investigators think and suggest that flavanols can have positive effects on the vascularly system, more specifically on the peripheral and cerebral blood vessels. The effects are only observed in a healthy populations, meanwhile patient populations like diabetes patients could really benefit from this. This is why the investigators will execute this study.

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Detailed Description

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The study population is divided into 3 main groups, namely healthy controls, patients with diabetes type 2 (defined by American Diabetes Association's (ADA)) and patients with essential hypertension (the latter group is again divided into 3 subgroups: use of betablockers, angiotensin-converting enzyme (ACE)-inhibitors, angiotensin-receptor blockers (ARBs). Each main goup will consist of minimal 20 subjects.

In this interventional study the investigators ask the patient to come twice. One time they get capsules with real flavanols and the other time they get capsules with a placebo. The study will be double blinded so nor the investigators, nor the patients now at which investigation they get the real flavanols or the placebo.

Before and after the intake of these capsules, a few measurements will take place. These measurements will be compared on the one hand with the second investigation day (inter-patients and intra-patient) and on the other hand with the pre-intake measurements (intra-patient).

The different examinations are a Flow-mediated dilatation (FMD) test, blood pressure analysis and an exercise test.

The investigator who performs the FMD-test, followed a course and needed to pass an examination.

The blood pressure measurements will be continuously for 20 minutes to avoid to much bias.

Conditions

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Vascular Complications, Diabetic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

The different capsules are separated into 2 boxes but both sorts of capsules have the same colour and size. They just have a different number marked on the white box. During the investigation day, the participant chooses an envelope marked with number 1 or number 2 leading to the decision of the box and thus the capsules they will get.

Study Groups

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Healthy persons

In this interventional study the investigators ask the patient (healthy persons) to come twice. One time they get capsules (6 or 8) with real flavanols (subgroup of polyphenols, subgroup of phenolics, natural substances) and the other time they get capsules with a placebo

Group Type EXPERIMENTAL

flavanols (subgroup of polyphenols, subgroup of phenolics, natural substances)

Intervention Type DIETARY_SUPPLEMENT

single intake of capsules with flavanols (subgroup of polyphenols, subgroup of phenolics, natural substances)

Placebo

Intervention Type OTHER

single intake of capsules with a placebo

Persons with essential hypertension

In this interventional study the investigators ask the patient (persons with essential hypertension) to come twice. One time they get capsules (6 or 8) with real flavanols (subgroup of polyphenols, subgroup of phenolics, natural substances) and the other time they get capsules with a placebo

Group Type EXPERIMENTAL

flavanols (subgroup of polyphenols, subgroup of phenolics, natural substances)

Intervention Type DIETARY_SUPPLEMENT

single intake of capsules with flavanols (subgroup of polyphenols, subgroup of phenolics, natural substances)

Placebo

Intervention Type OTHER

single intake of capsules with a placebo

Persons with type 2 diabetes

In this interventional study the investigators ask the patient (persons with type 2 diabetes) to come twice. One time they get capsules (6 or 8) with real flavanols (subgroup of polyphenols, subgroup of phenolics, natural substances) and the other time they get capsules with a placebo

Group Type EXPERIMENTAL

flavanols (subgroup of polyphenols, subgroup of phenolics, natural substances)

Intervention Type DIETARY_SUPPLEMENT

single intake of capsules with flavanols (subgroup of polyphenols, subgroup of phenolics, natural substances)

Placebo

Intervention Type OTHER

single intake of capsules with a placebo

Interventions

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flavanols (subgroup of polyphenols, subgroup of phenolics, natural substances)

single intake of capsules with flavanols (subgroup of polyphenols, subgroup of phenolics, natural substances)

Intervention Type DIETARY_SUPPLEMENT

Placebo

single intake of capsules with a placebo

Intervention Type OTHER

Other Intervention Names

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flavanoids

Eligibility Criteria

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Inclusion Criteria

* men and woman, age 18 - 85 years old, diabetes type 2 and/or using 1 sort of blood pressure lowering medication (betablockers, calcium-antagonists, RAAS-inhibitors)

Exclusion Criteria

* GENERAL: diabetes type 1, maturity-onset diabetes of youth (MODY), Latent Autoimmune Diabetes of the Adult (LADA), smokers, alcohol abuse, active cancer, chronic inflammatory disease
* MICROVASCULAR: retinopathy, diabetic/hypertensive nephropathy, peripheral sensoric neuropathy, autonomic neuropathy
* MACROVASCULAR: cardiovascular diseases, cerebrovascular diseases, active or chronic palindromic vasculitis
* MEDICATION with impact on endothelial function: NO-containing medication, phosphodiesterase Type 5 -inhibitors
* DISEASES who can affect the exercise test: chronic obstructive pulmonary disease (COPD) with Global Initiative for Chronic Obstructive Lung Disease (GLOD) -stages III and IV, Heart failure class 3 and 4, serious musculoskeletal diseases
* OTHER: pregnancy

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes