Grape Extract and Exercise Effects on Blood Pressure

NCT06985407 | Completed DMC

• 1 other identifier: POLYPHENOL-EXER-CARDIOVACULAR
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Exercise Response; Blood Pressure Monitoring, Ambulatory; Polyphenol

Keywords

Grape extract; Exercise; Vascular function; Blood Pressure; Polyphenol

Outcome Measures

Primary Outcomes (4)

• 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)

Secondary Outcomes (9)

• Postexercise heart rate (bpm)

  Acute/chronic effects (0 and 7 days)

• Plasma nitric oxide concentrations (μmol L-1)

  Acute/chronic effects (0 and 7 days)

• Circulating endothelial biomarkers

  Acute/chronic effects (0 and 7 days)

• Exercise total carbohydrate oxidation (g min-1)

  Acute/chronic effects (0 and 7 days)

• Exercise total fat oxidation (g min-1)

  Acute/chronic effects (0 and 7 days)

Study Arms (2)

Grape extract (VinteraTM Premium OPC)

EXPERIMENTAL

Dietary Supplement: Grape extract (VinteraTM Premium OPC)

Placebo

PLACEBO COMPARATOR

Dietary Supplement: Control (placebo) group

Interventions

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.

Grape extract (VinteraTM Premium OPC)

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.

Placebo

Eligibility Criteria

• Age: 25 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Castilla-La Mancha: lead

Study Sites (1)

UCLM

Toledo, Spain

Location

MeSH Terms

Conditions

Motor Activity

Interventions

whole grape extract; Population Groups

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Demography; Population Characteristics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD; Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: May 6, 2025
• First Posted: May 22, 2025
• Study Start: February 10, 2026
• Primary Completion: May 5, 2026
• Study Completion: May 5, 2026
• Last Updated: May 6, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR

Locations

ES (1)