Effect of monomeric and oligomeric flavanols on exercise blood pressure and vascular function in healthy volunteers

Completed

Conditions: high normal blood pressure
exercise-induced increase in blood pressure
vascular health

Registration Number: NL-OMON56275

Lead Sponsor: niversiteit Maastricht

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 41

Inclusion Criteria

1. Healthy men and women with normal to high-normal resting blood pressure
(systolic blood pressure (SBP) 120 - 139 mm Hg and diastolic blood pressure 80
- 89 mm Hg).
2. Age 35 - 65 years
3. BMI 20 - 32 kg/m^2
4. Hypertensive response to maximal exercise test defined as SBP >= 200 mm Hg
(men) and >= 180 mm Hg (women).

Exclusion Criteria

1. Active engagement in the weight loss programs, also including slimming
diets.
2. Active smoking or abstinence from smoking for less than one year.
3. Use of medications that reduce BP and/or can potentially influence other
study outcomes (ACE-inhibitors, angiotensin receptor blockers, diuretics,
painkillers, etc).
4. Intake of polyphenol-containing supplements for two month before and during
the whole course of the study.
5. History of diabetes, cardiovascular, respiratory, renal, gastrointestinal,
hepatic or other diseases and conditions, which potentially can compromise
participation in this study.
6. Intense sporting (>10 h/week) and/or participation in the competition at the
professional level.
7. Pregnancy or breastfeeding.
8. Participation in a clinical trial within four weeks prior to inclusion into
this study.
9. Vaccination against Covid-19 within two months before the
screening/randomization visit or expected vaccination against Covid-19 during
the study.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Main study outcomes are changes in systolic blood pressure (SBP) during<br /><br>submaximal exercise test. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>• Mean blood pressure (MBP) during submaximal exercise test<br /><br>• Hemodynamic parameters: SBP, diastolic blood pressure (DBP) and heart rate<br /><br>(HR) during rest and recovery from submaximal exercise, HR and DBP at<br /><br>submaximal exercise<br /><br>• Carotid femoral pulse wave velocity, central aortic BP, augmentation index<br /><br>• Biomarkers of RAAS activation: angiotensin II, renin, aldosterone<br /><br>• Biomarkers of inflammation: high-sensitivity C-reactive protein , interleukin<br /><br>(IL)-6, tumor necrosis factor-alpha<br /><br>• Biomarkers of oxidative stress: malondialdehyde, trolox equivalent<br /><br>antioxidant capacity<br /><br>• Biomarkers of endothelial function: endothelin-1, nitrite/nitrate<br /><br>• Biomarkers of vascular remodelling: metalloproteinase (MMP)-9, MMP-2, tissue<br /><br>inhibitor of metalloproteinase (TIMP)-1, TIMP-4.</p><br>