Grape Extract and Exercise Effects on Blood Pressure

Not Applicable

Not yet recruiting

• Conditions: Exercise Response; Blood Pressure Monitoring, Ambulatory; Polyphenol

• Registration Number: NCT06985407
• Lead Sponsor: University of Castilla-La Mancha

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-05
• Study First Submitted: 2025-05-06
• Study First Submitted QC: 2025-05-14
• Last Update Submitted: 2025-05-14
• Study First Posted: 2025-05-22
• Last Update Posted: 2025-05-22
• Study Start: 2025-10
• Primary Completion: 2026-04
• Study Completion: 2026-06

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 12

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Postexercise systolic and diastolic blood pressure (mmHg)	Acute/chronic effects (0 and 7 days)	Blood pressure will be measured in triplicated each 5 min during 40 minutes of supine rest.
Brachial blood flow (ml·min-1)	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.
24-hour ambulatory blood pressure following exercise (mmHg)	Acute/chronic effects (0 and 7 days)	Ambulatory blood pressure will be assessed for 24 hours.
Brachial flow-mediated dilation (%)	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.

Secondary Outcome Measures

Name	Time	Method
Plasma insulin concentrations (µIU mL-1)	Acute/chronic effects (0 and 7 days)	Serum concentrations of insulin after 8-hour fasting
Circulating endothelial biomarkers	Acute/chronic effects (0 and 7 days)	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)
Exercise total carbohydrate oxidation (g min-1)	Acute/chronic effects (0 and 7 days)	Total whole-body carbohydrate rates were calculated using non-protein Péronnet and Massicotte's equations
Exercise total fat oxidation (g min-1)	Acute/chronic effects (0 and 7 days)	Total whole-body fat oxidation rates were calculated using non-protein Péronnet and Massicotte's equations
Postexercise heart rate (bpm)	Acute/chronic effects (0 and 7 days)	Post-exercise heart rate will be assessed for 40 minutes after completing the exercise.
Plasma nitric oxide concentrations (μmol L-1)	Acute/chronic effects (0 and 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%).
Heart rate during exercise (bpm)	Acute/chronic effects (0 and 7 days)	Heart rate will be continuously assessed during exercise
Systolic and diastolic blood pressure during exercise (mmHg)	Acute/chronic effects (0 and 7 days)	Blood pressure will be assessed during high intensity intervals.
Plasma glucose concentrations (mg dL-1)	Acute/chronic effects (0 and 7 days)	Serum concentrations of glycemia (in mg per dL) after 8-hour fasting