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

• Sponsor: University Ghent (Other)
• Overall Status: Completed
• CT.gov ID: NCT03722199
• Collaborator: (none)
• Enrollment: 43
• Location: 1
• Arms: 3
• Actual Duration (Months): 30.6
• Patients Per Site Per Month: 1.4

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Vascular Complications, Diabetic	Dietary Supplement: flavanols (subgroup of polyphenols, subgroup of phenolics, natural substances); Other: Placebo	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 43 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Masking Description: 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.
• Primary Purpose: Prevention
• Official Title: Effects of Flavanoids on Acute Peripheral Vascular Reactivity in Essential Hypertension, Type 2 Diabetes and Healthy Persons
• Actual Study Start Date: Sep 1, 2018
• Actual Primary Completion Date: Mar 20, 2021
• Actual Study Completion Date: Mar 20, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. FMD -Flow mediated dilatation test [20 minutes]

   Flow mediated dilatation test

Secondary Outcome Measures

1. blood pressure analysis [25 minutes]

   analysis of changes in systolic or diastolic blood pressure

Other Outcome Measures

1. Near-infrared spectroscopy during exercise [25 minutes]

   analysis of changes in oxygenated blood during exercise

2. exercise test with hand held dynamometer [25 minutes]

   analysis of changes in maximal capacity

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 85 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Ghent	Ghent	Oost-Vlaanderen	Belgium	9000

Sponsors and Collaborators

• University Ghent

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University Ghent
• ClinicalTrials.gov Identifier: NCT03722199
• Other Study ID Numbers: B670201835660
• First Posted: Oct 26, 2018
• Last Update Posted: Apr 20, 2021
• Last Verified: Aug 1, 2020

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• 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
• Keywords provided by University Ghent: flavanols; diabetes type 2; essential hypertension; peripheral vascular function
• Additional relevant MeSH terms: Hypertension; Essential Hypertension; Diabetic Angiopathies

Study Results

No Results Posted as of Apr 20, 2021