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| Name | Class |
|---|---|
| VieCuri Medical Centre | OTHER |
| CEP Group Holding B.V. | UNKNOWN |
| Campus Venlo | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MOF/placebo | Other | During period 1 (4 weeks) participants will receive monomeric and oligomeric flavanols and during period 2 (4 weeks) placebo. Wash out period between two interventions will be 4 weeks. The daily dose of monomeric and oligomeric flavanols will be 200 mg (2 capsules once a day) and for placebo (2 capsules once a day). |
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| Placebo/MOF | Other | During period 1 (4 weeks) participants will receive placebo and during period 2 (4 weeks) monomeric and oligomeric flavanols. The wash out period between two interventions will be 4 weeks. The daily dose of placebo will be 2 capsules once a day and for monomeric and oligomeric flavanols 200 mg (2 capsules once a day). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Monomeric and oligomeric flavanols | Dietary Supplement | Monomeric and oligomeric flavanols will be derived from Vitis vinifera seeds extract. |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in systolic blood pressure from before to peak value during the submaximal exercise test | 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. | Day 28±3, Day 84±3 |
| Change in mean blood pressure from before to peak value during the submaximal exercise test | Increase in mean blood pressure during exercise is related to signs of endothelial dysfunction. | Day 28±3, Day 84±3 |
| Measure | Description | Time Frame |
|---|---|---|
| Carotid-femoral pulse wave velocity | Carotid-femoral pulse wave velocity reflects arterial stiffness and is related to the cardiovascular risk. | Day 28±3, Day 84±3 |
| Biomarkers of RAAS activation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Khrystyna O. Semen, MD, PhD | Professor assistant | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VieCuri Medical Center | Venlo | Limburg | 5912 BL | Netherlands |
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| ID | Term |
|---|---|
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Placebo | Other | Placebo capsuled will be used as a comparator. |
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Renin, angiotensin II and aldosterone are involved in regulation of blood pressure response also during exercise.
| Day 28±3, Day 84±3 |
| Biomarkers of inflammation | High-sensitivity C-reactive protein (hs-CRP), interleukin (IL)-6, tumor necrosis factor-alpha (TNFalpha) are well-recognized molecules that characterize inflammation. | Day 28±3, Day 84±3 |
| Biomarkers of oxidative stress | 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. | Day 28±3, Day 84±3 |
| Biomarkers of endothelial function | Endothelin 1 and levels of nitrate/nitrite are commonly used to assess endothelial function and characterize balance between vasodilation and vasoconstriction. | Day 28±3, Day 84±3 |
| Biomarkers of vascular remodelling | 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. | Day 28±3, Day 84±3 |
| Other hemodynamic parameters | 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. | Day 28±3, Day 84±3 |