HealthyNCT04907097
Effect of MOF on Exercise Blood Pressure
A study testing Monomeric and oligomeric flavanols in people with Healthy, run by Maastricht University Medical Center at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 35 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Monomeric and oligomeric flavanols
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteNetherlands
- Study dates
- 5 Apr 2022to 16 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Monomeric and Oligomeric Flavanols on Exercise Blood Pressure and Vascular Function in Healthy Volunteers
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.
Read the 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 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.
- Conditions
- Healthy
- Being tested
- Monomeric and oligomeric flavanols, Placebo
- Keywords
- Vascular function, Monomeric and oligomeric flavanols, Grape seeds extract, Exercise blood pressure, Inflammation
- Medical subject headings
- Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Monomeric and oligomeric flavanolsDietary supplement
Also called Masquelier's original OPCs
Monomeric and oligomeric flavanols will be derived from Vitis vinifera seeds extract.
PlaceboOther
Placebo capsuled will be used as a comparator.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Dietary Supplement: Monomeric and oligomeric flavanols; Other: Placebo |
| 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). Receives: Dietary Supplement: Monomeric and oligomeric flavanols; Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Day 28±3, Day 84±3
Secondary outcomes (7)
Carotid-femoral pulse wave velocity
Carotid-femoral pulse wave velocity reflects arterial stiffness and is related to the cardiovascular risk.
Measured: Day 28±3, Day 84±3
Biomarkers of RAAS activation
Renin, angiotensin II and aldosterone are involved in regulation of blood pressure response also during exercise.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Day 28±3, Day 84±3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2021
- Study start5 Apr 2022
- Primary completion16 May 2024
- Study completion16 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Maastricht University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- VieCuri Medical Centre, CEP Group Holding B.V., Campus Venlo
- Responsible party
- Principal investigator, Khrystyna Semen, Maastricht University Medical Center
- Investigators
- Khrystyna O. Semen, MD, PhD, Principal investigator, Professor assistant
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04907097
- Sponsor's protocol ID
- NL77344.068.21
- Status last verified
- Jun 2024
- First submitted
- 25 May 2021
- Last updated
- 21 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Monomeric and Oligomeric Flavanols on Exercise Blood Pressure and Vascular Function in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT04907097
- Acronym / sponsor ID
- NL77344.068.21
- Conditions
- Healthy
- Keywords
- Vascular function, Monomeric and oligomeric flavanols, Grape seeds extract, Exercise blood pressure, Inflammation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Collaborators
- VieCuri Medical Centre, CEP Group Holding B.V., Campus Venlo
- Study start
- 5 Apr 2022 (actual)
- Primary completion
- 16 May 2024 (actual)
- Study completion
- 16 May 2024 (actual)
- First posted
- 28 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MOF/placebo | Other | Dietary Supplement: Monomeric and oligomeric flavanols, Other: PlaceboDuring 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). |
| Placebo/MOF | Other | Dietary Supplement: Monomeric and oligomeric flavanols, Other: PlaceboDuring 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). |
Who may qualify
- Ages
- 35 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Monomeric and oligomeric flavanolsAlso: Masquelier's original OPCsMonomeric and oligomeric flavanols will be derived from Vitis vinifera seeds extract. | Dietary supplement | MOF/placebo, Placebo/MOF |
| PlaceboPlacebo capsuled will be used as a comparator. | Other | MOF/placebo, Placebo/MOF |
Primary outcome
Change in systolic blood pressure from before to peak value during the submaximal exercise test
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.
Change in mean blood pressure from before to peak value during the submaximal exercise test
Time frame: Day 28±3, Day 84±3
Increase in mean blood pressure during exercise is related to signs of endothelial dysfunction.
7 secondary outcomes
Carotid-femoral pulse wave velocity
Time frame: Day 28±3, Day 84±3
Biomarkers of RAAS activation
Time frame: Day 28±3, Day 84±3
Biomarkers of inflammation
Time frame: Day 28±3, Day 84±3
Biomarkers of oxidative stress
Time frame: Day 28±3, Day 84±3
Biomarkers of endothelial function
Time frame: Day 28±3, Day 84±3
Biomarkers of vascular remodelling
Time frame: Day 28±3, Day 84±3
Other hemodynamic parameters
Time frame: Day 28±3, Day 84±3
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Khrystyna O. Semen, MD, PhD principal investigator
Professor assistant
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Monomeric and oligomeric flavanols in people with Healthy, run by Maastricht University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in systolic blood pressure from before to peak value during the submaximal exercise test (time frame: Day 28±3, Day 84±3). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jun 2024.