Objective: to evaluate the effects of MOF in comparison to placebo on exercise blood pressure, endothelial function, inflammatory and redox status in healthy volunteers. In addition, the study will aim to assess the impact of MOF supplementation on…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
high normal blood pressure
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Main study outcomes are changes in systolic blood pressure (SBP) during
submaximal exercise test.
Secondary outcome
• Mean blood pressure (MBP) during submaximal exercise test
• Hemodynamic parameters: SBP, diastolic blood pressure (DBP) and heart rate
(HR) during rest and recovery from submaximal exercise, HR and DBP at
submaximal exercise
• Carotid femoral pulse wave velocity, central aortic BP, augmentation index
• Biomarkers of RAAS activation: angiotensin II, renin, aldosterone
• Biomarkers of inflammation: high-sensitivity C-reactive protein , interleukin
(IL)-6, tumor necrosis factor-alpha
• Biomarkers of oxidative stress: malondialdehyde, trolox equivalent
antioxidant capacity
• Biomarkers of endothelial function: endothelin-1, nitrite/nitrate
• Biomarkers of vascular remodelling: metalloproteinase (MMP)-9, MMP-2, tissue
inhibitor of metalloproteinase (TIMP)-1, TIMP-4.
Background summary
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. We hypothesize that supplementation with MOF
in healthy prehypertensive individuals will modulate vascular function and
optimize exercise BP response.
Study objective
Objective: to evaluate the effects of MOF in comparison to placebo on exercise
blood pressure, endothelial function, inflammatory and redox status in healthy
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 remodelling of extracellular matrix.
Study design
Single-centre, double-blinded, placebo-controlled, 4 week interventional,
cross-over study
Intervention
Subjects will receive 200 mg (two capsules of 100 mg) monomeric and oligomeric
flavanols for 28±3 days and 200 mg (two capsules of placebo) for 28±3 days in a
randomized sequence. The duration of washout period between two interventions
will be 28±3 days.
Study burden and risks
Participation in this study will entail three site visits distributed over a
three-month period. During the study research subjects will be asked to undergo
two submaximal exercise tests on a bicycle ergometer with monitoring of the BP
and heart rate before, during and after the test. In addition, maximal
exercise test will be performed in cases when such recent historical test is
not available. Participants may encounter a physiological discomfort related to
the (sub)maximal exercise loads. The risk of adverse events during (sub)maximal
exercise testing in healthy volunteers is regarded as very low. Blood samples
will be collected before and after submaximal exercise tests, four times in
total during the study. Medical history, use of medication and food supplements
will be assessed by questionnaires. The risk associated with an intake of the
investigational product (MOF/placebo) can be regarded as minimal. Only a few
AEs, namely mild gastrointestinal discomfort which resolved spontaneously, were
reported in subjects participating in previous studies involving use of MOF.
Direct benefit for study participants is hard to predict. However, the findings
of this trial will help to identify nutritional strategies that might be useful
for optimization of exercise BP response and reduction of CV risks in healthy
volunteers.
Nassaustraat 36
Venlo 5911BV
NL
Nassaustraat 36
Venlo 5911BV
NL
Listed location countries
Age
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.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT04907097 |
| CCMO | NL77344.068.21 |