Clinical trial NCT06985407: Grape Extract and Exercise Effects on Blood Pressure
Official title: Acute and Chronic Effects of Grape Extract on Cardiovascular Response Following Exercise
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Exercise Response
Blood Pressure Monitoring, Ambulatory
Polyphenol
Keywords: Grape extract
Exercise
Vascular function
Blood Pressure
Polyphenol
Lead sponsor: University of Castilla-La Mancha
Sponsor class: OTHER
Collaborators: name: Alvinesa Natural Ingredients
First posted: 2025-05-22
Enrollment: 12
Sex: ALL
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention 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 Red Grape). The randomization will be counterbalanced and stratified by sex, and the design will follow a double-blind design. Then, six participants (3 males and 3 females) will start the control condition, and the other group (3 males and 3 females) 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.
Primary purpose: TREATMENT

Brief 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. 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.


Eligibility criteria: Inclusion Criteria:

* Sedentary individuals (\<120 min·wk-1 of moderate-intensity activity assessed by 7-d IPAQ).
* Aged 25-65 years and BMI 18-35 kg/m2.
* Elevated BP (i.e., prehypertensive; systolic and diastolic BP between 120-139 and/or 80-89 mmHg, respectively)

Exclusion Criteria:

* 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 (≥140 mmHg systolic, or ≥90 mmHg diastolic BP), and any disease associated with exercise intolerance.
* Under pharmacological treatment for any cardiometabolic disease (i.e., hypertension, dyslipidemia or hyperglycemia)
* 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)

Primary outcomes:
measure: Postexercise systolic and diastolic blood pressure (mmHg)
timeFrame: Acute/chronic effects (0 and 7 days)
measure: 24-hour ambulatory blood pressure following exercise (mmHg)
timeFrame: Acute/chronic effects (0 and 7 days)
measure: Brachial flow-mediated dilation (%)
timeFrame: Acute/chronic effects (0 and 7 days)
measure: Brachial blood flow (ml·min-1)
timeFrame: Acute/chronic effects (0 and 7 days)
Secondary outcomes:
measure: Postexercise heart rate (bpm)
timeFrame: Acute/chronic effects (0 and 7 days)
measure: Plasma nitric oxide concentrations (μmol L-1)
timeFrame: Acute/chronic effects (0 and 7 days)
measure: Circulating endothelial biomarkers
timeFrame: Acute/chronic effects (0 and 7 days)
measure: Exercise total carbohydrate oxidation (g min-1)
timeFrame: Acute/chronic effects (0 and 7 days)
measure: Exercise total fat oxidation (g min-1)
timeFrame: Acute/chronic effects (0 and 7 days)
measure: Heart rate during exercise (bpm)
timeFrame: Acute/chronic effects (0 and 7 days)
measure: Systolic and diastolic blood pressure during exercise (mmHg)
timeFrame: Acute/chronic effects (0 and 7 days)
measure: Plasma glucose concentrations (mg dL-1)
timeFrame: Acute/chronic effects (0 and 7 days)
measure: Plasma insulin concentrations (µIU mL-1)
timeFrame: Acute/chronic effects (0 and 7 days)
Other outcomes:
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