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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Grape extract (VinteraTM Premium OPC) | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Postexercise systolic and diastolic blood pressure (mmHg) | Blood pressure will be measured in triplicated each 5 min during 40 minutes of supine rest. | Acute/chronic effects (0 and 7 days) |
| 24-hour ambulatory blood pressure following exercise (mmHg) | Ambulatory blood pressure will be assessed for 24 hours. | 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. | 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. | Acute/chronic effects (0 and 7 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Postexercise heart rate (bpm) | Post-exercise heart rate will be assessed for 40 minutes after completing the exercise. | Acute/chronic effects (0 and 7 days) |
| Plasma nitric oxide concentrations (μmol L-1) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCLM | Toledo | Spain |
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| ID | Term |
|---|---|
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D001519 | Behavior |
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| ID | Term |
|---|---|
| C000722782 | whole grape extract |
| D044382 | Population Groups |
| ID | Term |
|---|---|
| D003710 | Demography |
| D011154 | Population Characteristics |
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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.
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Several strategies will be used to ensure the double-blind design. First, both formulations will contain identical inert excipients (such as microcrystalline cellulose, magnesium salts of fatty acids, or silicon dioxide) to ensure indistinguishable taste, smell, and texture. Furthermore, the capsules will be identical in color, size, and shape, using standard materials that prevent distinction of the contents. Both formulations will be non-calorie flavoured, avoiding taste differences, especially if the capsules are accidentally chewed. Furthermore, encapsulation will be performed by a specialized laboratory, such as Alvinesa Natural Ingredients, ensuring a consistent preparation. Finally, the capsules will be distributed in identical packaging without distinctive markings that could compromise the double-blind design.
| Control (placebo) group | 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. |
|
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%).
| 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) | 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 | 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 | Acute/chronic effects (0 and 7 days) |
| Heart rate during exercise (bpm) | Heart rate will be continuously assessed during exercise | Acute/chronic effects (0 and 7 days) |
| Systolic and diastolic blood pressure during exercise (mmHg) | Blood pressure will be assessed during high intensity intervals. | 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 | Acute/chronic effects (0 and 7 days) |
| Plasma insulin concentrations (µIU mL-1) | Serum concentrations of insulin after 8-hour fasting | Acute/chronic effects (0 and 7 days) |