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

April 19, 2021 updated by: University Ghent

Effects of Flavanoids on Acute Peripheral Vascular Reactivity in Essential Hypertension, Type 2 Diabetes and Healthy Persons

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

43

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
    • Oost-Vlaanderen
      • Ghent, Oost-Vlaanderen, Belgium, 9000
        • University of Ghent

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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
Dietary supplement: flavanols (subgroup of polyphenols, subgroup of phenolics, natural substances)
single intake of capsules with flavanols (subgroup of polyphenols, subgroup of phenolics, natural substances)
Other Names:
  • flavanoids
Other: Placebo
single intake of capsules with a placebo
Experimental: 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
Dietary supplement: flavanols (subgroup of polyphenols, subgroup of phenolics, natural substances)
single intake of capsules with flavanols (subgroup of polyphenols, subgroup of phenolics, natural substances)
Other Names:
  • flavanoids
Other: Placebo
single intake of capsules with a placebo
Experimental: 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
Dietary supplement: flavanols (subgroup of polyphenols, subgroup of phenolics, natural substances)
single intake of capsules with flavanols (subgroup of polyphenols, subgroup of phenolics, natural substances)
Other Names:
  • flavanoids
Other: Placebo
single intake of capsules with a placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
FMD -Flow mediated dilatation test
Time Frame: 20 minutes
Flow mediated dilatation test
20 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
blood pressure analysis
Time Frame: 25 minutes
analysis of changes in systolic or diastolic blood pressure
25 minutes

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Near-infrared spectroscopy during exercise
Time Frame: 25 minutes
analysis of changes in oxygenated blood during exercise
25 minutes
exercise test with hand held dynamometer
Time Frame: 25 minutes
analysis of changes in maximal capacity
25 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Ghent

Investigators

  • Principal Investigator: Samyah Shadid, Prof. Dr., Universal hospital of Ghent and university of Ghent

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2018

Primary Completion (Actual)

March 20, 2021

Study Completion (Actual)

March 20, 2021

Study Registration Dates

First Submitted

September 28, 2018

First Submitted That Met QC Criteria

October 25, 2018

First Posted (Actual)

October 26, 2018

Study Record Updates

Last Update Posted (Actual)

April 20, 2021

Last Update Submitted That Met QC Criteria

April 19, 2021

Last Verified

August 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B670201835660

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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