Clinical Trials Logo

Clinical Trial Summary

The purpose of this study is to establish an effect of monomeric and oligomeric flavanols supplementation on exercise blood pressure and vascular function in healthy volunteers.


Clinical Trial Description

Exaggerated exercise blood pressure (BP) response in healthy subjects is recognized as a risk factor of hypertension and cardiovascular events. Pathogenetically exaggerated BP response is attributed to compromised vascular(endothelial) functions as well as oxidative stress and inflammation. Monomeric and oligomeric flavanols (MOF) are dietary components with well-characterized beneficial effects on the redox homeostasis, endothelial function and microvascular health. The objectives of the study will be to evaluate the effects of MOF in comparison to placebo on exercise blood pressure, endothelial function, inflammatory and redox status in healthy prehypertensive volunteers. In addition, the study will aim to assess the impact of MOF supplementation on the exercise-induced renin-angiotensin-aldosterone system (RAAS) activation and extracellular matrix remodelling. After being informed about the study and potential risks all volunteers signing informed consent form will undergo screening to determine eligibility for the study. Eligible subjects will be randomized in the double-blind manner to monomeric and oligomeric flavanols /placebo or placebo/monomeric and oligomeric flavanols sequence (cross-over design) in a 1:1 ratio. Monomeric and oligomeric flavanols are derived from grape seeds extract and will be administered in a dose 200 mg per day. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04907097
Study type Interventional
Source Maastricht University Medical Center
Contact Khrystyna O. Semen, MD, PhD
Phone +31630412370
Email [email protected]
Status Not yet recruiting
Phase N/A
Start date November 2021
Completion date June 2023

See also
  Status Clinical Trial Phase
Terminated NCT04556032 - Effects of Ergothioneine on Cognition, Mood, and Sleep in Healthy Adult Men and Women N/A
Completed NCT04065295 - A Study to Test How Well Healthy Men Tolerate Different Doses of BI 1356225 Phase 1
Completed NCT04107441 - AX-8 Drug Safety, Tolerability and Plasma Levels in Healthy Subjects Phase 1
Completed NCT01442831 - Evaluate the Absorption, Metabolism, And Excretion Of Orally Administered [14C] TR 701 In Healthy Adult Male Subjects Phase 1
Recruiting NCT04714294 - Evaluate the Safety, Tolerability and Pharmacokinetics Characteristics of HPP737 in Healthy Volunteers Phase 1
Recruiting NCT04539756 - Writing Activities and Emotions N/A
Recruiting NCT04494269 - A Study to Evaluate Pharmacokinetics and Safety of Tegoprazan in Subjects With Hepatic Impairment and Healthy Controls Phase 1
Recruiting NCT04098510 - Concentration of MitoQ in Human Skeletal Muscle N/A
Completed NCT03308110 - Bioavailability and Food Effect Study of Two Formulations of PF-06650833 Phase 1
Completed NCT04052711 - A Randomized, Controlled Study to Evaluate the Sensitizing Potential of FMX-101 in Healthy Volunteers Using a Repeat Insult Patch Test Design Phase 1
Terminated NCT00001844 - Study of New Magnetic Resonance Methods
Completed NCT04451811 - A PK Dose Proportionality Study of OPL-002 in Healthy Volunteers Phase 1
Completed NCT04319926 - Adhesion Performance Study of Lidocaine Topical System 1.8% Compared to Generic Lidocaine Patch 5% in Healthy, Adult, Human Subjects Phase 1
Completed NCT03160261 - Effect of Exenatide on Cortisol Secretion Phase 4
Completed NCT03662100 - A Study of Two Formulations of LY3074828 in Healthy Participants Phase 1
Recruiting NCT02875301 - Investigating Gains in Neurocognition in an Intervention Trial of Exercise Phase 3
Completed NCT01437592 - Investigating the Pharmacokinetic Properties of NN1250 in Healthy Chinese Subjects Phase 1
Completed NCT03670082 - Study With Lu AF35700 in Healthy Men and Women in Fasting and Fed State Phase 1
Completed NCT03656952 - A Study to Evaluate the PF-06700841 Effect on QTc Interval in Healthy Volunteers Phase 1
Completed NCT03056846 - Probiotics on Stress-associated Gastrointestinal Function in University Students N/A