Exercise ResponseNCT06985407
Grape Extract and Exercise Effects on Blood Pressure
A study testing Grape extract (VinteraTM Premium OPC) in people with Exercise Response and Blood Pressure Monitoring, Ambulatory, run by University of Castilla-La Mancha at 1 site in Spain.
Trial summary
Exercise and grape extract intake (i.e., polyphenol-rich product) can independently improve blood pressure and endothelial function in prehypertensive individuals. Nevertheless, their combined effects remain unexplored. Read more about this study
- Who is it for?
- Ages 25 to 70 years
- Conditions the study is for
- Exercise Response, Blood Pressure Monitoring, Ambulatory, Polyphenol
- What is being tested?
- Grape extract (VinteraTM Premium OPC)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteSpain
- Study dates
- 10 Feb 2026to 5 May 2026
- 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 25 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Sedentary individuals (<120 min·wk-1 of moderate-intensity activity assessed by 7-d IPAQ).
- Aged 25-70 years and BMI 18-40 kg/m2.
- Elevated BP (i.e., prehypertensive; systolic and diastolic BP between 120-139 and/or 80-89 mmHg, respectively)
Who cannot join
- Weight instability (>5kg change in body mass over last 6 months)
- Pregnant or lactating
- Changes in physical activity over the last 3 months and planning on physical activity, or diet throughout the intervention.
- Untreated cardiovascular or renal disease, peripheral vascular disease, hypertension, and any disease associated with exercise intolerance.
- Currently taking dietary supplements that influence the cardiovascular response (e.g., polyphenols, omega-3 fatty acids, Magnesium, nitrates, L-arginine, red ginseng, natto, ginkgo, CoQ10) or used in the last month.
- Current or recent use (within the past 6 months) of tobacco or nicotine-containing products, or illicit drugs.
- Any medical condition or medication that could introduce bias into the study (e.g. neurological disorders)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Acute and Chronic Effects of Grape Extract on Cardiovascular Response Following Exercise
Exercise and grape extract intake (i.e., polyphenol-rich product) can independently improve blood pressure and endothelial function in prehypertensive individuals. Nevertheless, their combined effects remain unexplored. Furthermore, since the biological pathways targeted by both interventions are similar, they could overlap and be amplified by one another, promoting additive or synergistic effects. Animal model studies have reported that a grape seed extract intake prevents exercise-induced oxidative stress, which could improve vascular dysfunction. Furthermore, as previously reported, a single dose of grape seed extract reduces blood pressure, peripheral vasoconstriction, and heart stress, enhancing O2 delivery during exercise in prehypertensive males. These effects may be partly due to endothelium-dependent vasodilation enhancement. Therefore, it is necessary to understand the potential impact of exercise and grape extract on blood pressure and vascular function in prehypertensive individuals.
- Being tested
- Grape extract (VinteraTM Premium OPC), Control (placebo) group
- Keywords
- Grape extract, Exercise, Vascular function, Blood Pressure, Polyphenol
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Grape extract (VinteraTM Premium OPC)Dietary supplement
Each condition will last 7 days for assessing both acute and chronic effects, and there will be a wash-out period of 7 days.
Control (placebo) groupDietary supplement
Each condition will last 7 days for assessing both acute and chronic effects, and there will be a wash-out period of 7 days.
| Study group | Role | What they receive |
|---|---|---|
| Grape extract (VinteraTM Premium OPC) | Experimental | Not described Receives: Dietary Supplement: Grape extract (VinteraTM Premium OPC) |
| Placebo | Placebo comparator | Not described Receives: Dietary Supplement: Control (placebo) group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postexercise systolic and diastolic blood pressure (mmHg)
Blood pressure will be measured in triplicated each 5 min during 40 minutes of supine rest.
Measured: Acute/chronic effects (0 and 7 days)
24-hour ambulatory blood pressure following exercise (mmHg)
Ambulatory blood pressure will be assessed for 24 hours.
Measured: Acute/chronic effects (0 and 7 days)
Brachial flow-mediated dilation (%)
Flow-mediated dilation (FMD) in the brachial artery will be performed via two-dimensional (2-D)/Doppler ultrasound.
Measured: Acute/chronic effects (0 and 7 days)
Brachial blood flow (ml·min-1)
Brachial artery blood flow will be assessed via 2-D/Doppler ultrasound. Each blood flow recording period will be at least 4 min long.
Measured: Acute/chronic effects (0 and 7 days)
Secondary outcomes (9)
Postexercise heart rate (bpm)
Post-exercise heart rate will be assessed for 40 minutes after completing the exercise.
Measured: Acute/chronic effects (0 and 7 days)
Plasma nitric oxide concentrations (μmol L-1)
Plasma nitric oxide concentrations will be determined using the enzymatic conversion of nitrate to nitrite by nitrate reductase (Thermoscientific; intra-and interassay CV 1.4%- 3.5%).
Measured: Acute/chronic effects (0 and 7 days)
Circulating endothelial biomarkers
Serum E-selectin concentration (ng mL-1); Serum P-selection concentration (ng mL-1); Serum Intracellular adhesion molecule 1 (ICAM-1) concentration (ng mL-1); Serum Vascular cell adhesion molecule 1 (VCAM-1) concentration (ng mL-1); Serum Tissue plasminogen activator (tPA) concentration (ng mL-1)
Measured: Acute/chronic effects (0 and 7 days)
Exercise total carbohydrate oxidation (g min-1)
Total whole-body carbohydrate rates were calculated using non-protein Péronnet and Massicotte's equations
Measured: Acute/chronic effects (0 and 7 days)
Exercise total fat oxidation (g min-1)
Total whole-body fat oxidation rates were calculated using non-protein Péronnet and Massicotte's equations
Measured: Acute/chronic effects (0 and 7 days)
Heart rate during exercise (bpm)
Heart rate will be continuously assessed during exercise
Measured: Acute/chronic effects (0 and 7 days)
Systolic and diastolic blood pressure during exercise (mmHg)
Blood pressure will be assessed during high intensity intervals.
Measured: Acute/chronic effects (0 and 7 days)
Plasma glucose concentrations (mg dL-1)
Serum concentrations of glycemia (in mg per dL) after 8-hour fasting
Measured: Acute/chronic effects (0 and 7 days)
Plasma insulin concentrations (µIU mL-1)
Serum concentrations of insulin after 8-hour fasting
Measured: Acute/chronic effects (0 and 7 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2025
- Study start10 Feb 2026
- Primary completion5 May 2026
- Study completion5 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Exercise ResponseStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- This study will be a crossover randomized control trial. Twelve sedentary adults (mix of males and females) with elevated blood pressure (i.e., prehypertension) will be recruited and, following preliminary and baseline testing, will perform two conditions in random order: a) control (placebo) and b) grape extract (VinteraTM Premium OPC). The randomization will be counterbalanced and stratified by sex, and the design will follow a double-blind design. Then, six participants will start the control condition, and the other group will initiate the grape extract condition. Each condition will last 7 days for assessing both acute and chronic effects, and there will be a wash-out period of 7 days.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Castilla-La Mancha
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Felix Morales Palomo, University of Castilla-La Mancha
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06985407
- Sponsor's protocol ID
- POLYPHENOL-EXER-CARDIOVACULAR
- Status last verified
- May 2026
- First submitted
- 6 May 2025
- Last updated
- 6 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Moreno-Cabanas A, Gonzalez-Garcia L, Mora-Gonzalez D, Villafafila-Martinez L, Mora-Rodriguez R, Morales-Palomo F. Effects of acute and short-term grape seed extract supplementation on blood pressure responses to exercise in individuals at cardiometabolic risk: a randomised, double-blind, placebo-controlled exploratory crossover trial. Clin Nutr ESPEN. 2026 Aug 29:105076. doi: 10.1016/j.clnesp.2026.105076. Online ahead of print.
PubMed 42668015
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute and Chronic Effects of Grape Extract on Cardiovascular Response Following Exercise
- ClinicalTrials.gov ID
- NCT06985407
- Acronym / sponsor ID
- POLYPHENOL-EXER-CARDIOVACULAR
- Keywords
- Grape extract, Exercise, Vascular function, Blood Pressure, Polyphenol
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of Castilla-La ManchaUniversity, hospital or other
- Study start
- 10 Feb 2026 (actual)
- Primary completion
- 5 May 2026 (actual)
- Study completion
- 5 May 2026 (actual)
- First posted
- 22 May 2025 (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.
Exercise and grape extract intake (i.e., polyphenol-rich product) can independently improve blood pressure and endothelial function in prehypertensive individuals. Nevertheless, their combined effects remain unexplored. Furthermore, since the biological pathways targeted by both interventions are similar, they could overlap and be amplified by one another, promoting additive or synergistic effects. Animal model studies have reported that a grape seed extract intake prevents exercise-induced oxidative stress, which could improve vascular dysfunction. Furthermore, as previously reported, a single dose of grape seed extract reduces blood pressure, peripheral vasoconstriction, and heart stress, enhancing O2 delivery during exercise in prehypertensive males. These effects may be partly due to endothelium-dependent vasodilation enhancement. Therefore, it is necessary to understand the potential impact of exercise and grape extract on blood pressure and vascular function in prehypertensive individuals.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- This study will be a crossover randomized control trial. Twelve sedentary adults (mix of males and females) with elevated blood pressure (i.e., prehypertension) will be recruited and, following preliminary and baseline testing, will perform two conditions in random order: a) control (placebo) and b) grape extract (VinteraTM Premium OPC). The randomization will be counterbalanced and stratified by sex, and the design will follow a double-blind design. Then, six participants will start the control condition, and the other group will initiate the grape extract condition. Each condition will last 7 days for assessing both acute and chronic effects, and there will be a wash-out period of 7 days.
| Arm | Type | Receives |
|---|---|---|
| Grape extract (VinteraTM Premium OPC) | Experimental | Dietary Supplement: Grape extract (VinteraTM Premium OPC) |
| Placebo | Placebo comparator | Dietary Supplement: Control (placebo) group |
Who may qualify
- Ages
- 25 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Sedentary individuals (<120 min·wk-1 of moderate-intensity activity assessed by 7-d IPAQ).
- Aged 25-70 years and BMI 18-40 kg/m2.
- Elevated BP (i.e., prehypertensive; systolic and diastolic BP between 120-139 and/or 80-89 mmHg, respectively)
Key exclusion criteria (7 listed)
- Weight instability (>5kg change in body mass over last 6 months)
- Pregnant or lactating
- Changes in physical activity over the last 3 months and planning on physical activity, or diet throughout the intervention.
- Untreated cardiovascular or renal disease, peripheral vascular disease, hypertension, and any disease associated with exercise intolerance.
- Currently taking dietary supplements that influence the cardiovascular response (e.g., polyphenols, omega-3 fatty acids, Magnesium, nitrates, L-arginine, red ginseng, natto, ginkgo, CoQ10) or used in the last month.
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 |
|---|---|---|
| Grape extract (VinteraTM Premium OPC)Each condition will last 7 days for assessing both acute and chronic effects, and there will be a wash-out period of 7 days. | Dietary supplement | Grape extract (VinteraTM Premium OPC) |
| Control (placebo) groupEach condition will last 7 days for assessing both acute and chronic effects, and there will be a wash-out period of 7 days. | Dietary supplement | Placebo |
Primary outcome
Postexercise systolic and diastolic blood pressure (mmHg)
Time frame: Acute/chronic effects (0 and 7 days)
Blood pressure will be measured in triplicated each 5 min during 40 minutes of supine rest.
24-hour ambulatory blood pressure following exercise (mmHg)
Time frame: Acute/chronic effects (0 and 7 days)
Ambulatory blood pressure will be assessed for 24 hours.
Brachial flow-mediated dilation (%)
Time frame: Acute/chronic effects (0 and 7 days)
Flow-mediated dilation (FMD) in the brachial artery will be performed via two-dimensional (2-D)/Doppler ultrasound.
Brachial blood flow (ml·min-1)
Time frame: Acute/chronic effects (0 and 7 days)
Brachial artery blood flow will be assessed via 2-D/Doppler ultrasound. Each blood flow recording period will be at least 4 min long.
9 secondary outcomes
Postexercise heart rate (bpm)
Time frame: Acute/chronic effects (0 and 7 days)
Plasma nitric oxide concentrations (μmol L-1)
Time frame: Acute/chronic effects (0 and 7 days)
Circulating endothelial biomarkers
Time frame: Acute/chronic effects (0 and 7 days)
Exercise total carbohydrate oxidation (g min-1)
Time frame: Acute/chronic effects (0 and 7 days)
Exercise total fat oxidation (g min-1)
Time frame: Acute/chronic effects (0 and 7 days)
Heart rate during exercise (bpm)
Time frame: Acute/chronic effects (0 and 7 days)
Systolic and diastolic blood pressure during exercise (mmHg)
Time frame: Acute/chronic effects (0 and 7 days)
Plasma glucose concentrations (mg dL-1)
Time frame: Acute/chronic effects (0 and 7 days)
Plasma insulin concentrations (µIU mL-1)
Time frame: Acute/chronic effects (0 and 7 days)
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 6 May 2026.
- Derived from this study: PubMed 42668015Moreno-Cabanas A, Gonzalez-Garcia L, Mora-Gonzalez D, Villafafila-Martinez L, Mora-Rodriguez R, Morales-Palomo F. Effects of acute and short-term grape seed extract supplementation on blood pressure responses to exercise in individuals at cardiometabolic risk: a randomised, double-blind, placebo-controlled exploratory crossover trial. Clin Nutr ESPEN. 2026 Aug 29:105076. doi: 10.1016/j.clnesp.2026.105076. Online ahead of print.
- Individual participant dataSharing planned: Yes
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Grape extract (VinteraTM Premium OPC) in people with Exercise Response and Blood Pressure Monitoring, Ambulatory, run by University of Castilla-La Mancha at 1 site in Spain.
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 3 inclusion and 7 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 6 May 2026. 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 Spain. 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. Some participants in this study may receive a placebo. 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?
Postexercise systolic and diastolic blood pressure (mmHg) (time frame: Acute/chronic effects (0 and 7 days)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06985407, which also lists 1 linked publication.
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 6 May 2026.