Status:
COMPLETED
Effect of MOF on Exercise Blood Pressure
Lead Sponsor:
Maastricht University Medical Center
Collaborating Sponsors:
VieCuri Medical Centre
CEP Group Holding B.V.
Conditions:
Healthy
Eligibility:
All Genders
35-65 years
Phase:
NA
Brief 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.
Detailed 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 t...
Eligibility Criteria
Inclusion
- Healthy men and women with normal to high-normal resting BP (SBP 120 - 139 mm Hg and DBP 80 - 89 mm Hg).
- Age 35 - 65 years
- BMI 20 - 32 kg/m\^2
- Hypertensive response to maximal exercise test defined as SBP ≥ 200 mm Hg (men) and ≥ 180 mm Hg (women).
Exclusion
- Active engagement in the weight loss programs, also including slimming diets.
- Active smoking or abstinence from smoking for less than one year.
- Use of medications that reduce BP and/or can potentially influence other study outcomes (ACE-inhibitors, angiotensin receptor blockers, diuretics, painkillers, etc).
- Intake of polyphenol-containing supplements for two month before and during the whole course of the study.
- History of diabetes, cardiovascular, respiratory, renal, gastrointestinal, hepatic or other diseases and conditions, which potentially can compromise participation in this study.
- Intense sporting (\>10 h/week) and/or participation in the competition at the professional level.
- Pregnancy or breastfeeding.
- Participation in a clinical trial within 4 weeks prior to inclusion into this study.
- Vaccination against Covid-19 within two months before the screening/randomization visit or expected vaccination against Covid-19 during the study
Key Trial Info
Start Date :
April 5 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 16 2024
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT04907097
Start Date
April 5 2022
End Date
May 16 2024
Last Update
June 21 2024
Active Locations (1)
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1
VieCuri Medical Center
Venlo, Limburg, Netherlands, 5912 BL