VieCuri Medical Center
Venlo, Limburg, 5912 BL, Netherlands
NCT Number: NCT04907097
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.
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Notify Me35 year–65 year
All sexes
Interventional
Not applicable
Venlo, Limburg, 5912 BL, Netherlands
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Monomeric and oligomeric flavanols will be derived from Vitis vinifera seeds extract.
Other names: Masquelier's original OPCs
Placebo capsuled will be used as a comparator.
Time frame: Day 28±3, Day 84±3
Excessive increase in systolic blood pressure during exercise is a well-characterized risk-factor of cardiovascular disease and is related to signs of sub clinical endothelial dysfunction.
Time frame: Day 28±3, Day 84±3
Increase in mean blood pressure during exercise is related to signs of endothelial dysfunction.
Time frame: Day 28±3, Day 84±3
Carotid-femoral pulse wave velocity reflects arterial stiffness and is related to the cardiovascular risk.
Time frame: Day 28±3, Day 84±3
Renin, angiotensin II and aldosterone are involved in regulation of blood pressure response also during exercise.
Time frame: Day 28±3, Day 84±3
High-sensitivity C-reactive protein (hs-CRP), interleukin (IL)-6, tumor necrosis factor-alpha (TNFalpha) are well-recognized molecules that characterize inflammation.
Time frame: Day 28±3, Day 84±3
Malondialdehyde (MDA), trolox equivalent antioxidant capacity (TEAC) reflect the activity lipid peroxidation and antioxidant defense and therefore are indicative about the condition of redox homeostasis.
Time frame: Day 28±3, Day 84±3
Endothelin 1 and levels of nitrate/nitrite are commonly used to assess endothelial function and characterize balance between vasodilation and vasoconstriction.
Time frame: Day 28±3, Day 84±3
Metalloproteinase (MMP)-9, MMP-2, tissue inhibitor of metalloproteinase (TIMP)-1, TIMP-4 are involved in modulation of extracellular matrix and their activity have been linked to vascular health.
Time frame: Day 28±3, Day 84±3
Values of systolic and diastolic blood pressure and heart rate at rest and during exercise recovery are indicators of cardiovascular risk and were related also to hemodynamic response during peak exercise.
Maastricht University Medical Center
Other
Effect of Monomeric and Oligomeric Flavanols on Exercise Blood Pressure and Vascular Function in Healthy Volunteers
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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