Grape Extract and Exercise Effects on Blood Pressure

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-10-31

Study Completion Date

2026-06-30

Brief Summary

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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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Detailed Description

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Conditions

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Exercise Response Blood Pressure Monitoring, Ambulatory Polyphenol

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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 Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

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.

Study Groups

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Grape extract (VinteraTM Premium Red Grape)

Group Type EXPERIMENTAL

Grape extract (VinteraTM Premium Red Grape)

Intervention Type 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.

Placebo

Group Type PLACEBO_COMPARATOR

Control (placebo) group

Intervention Type 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.

Interventions

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Grape extract (VinteraTM Premium Red Grape)

Each condition will last 7 days for assessing both acute and chronic effects, and there will be a wash-out period of 7 days.

Intervention Type DIETARY_SUPPLEMENT

Control (placebo) group

Each condition will last 7 days for assessing both acute and chronic effects, and there will be a wash-out period of 7 days.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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)

Minimum Eligible Age

25 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No