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Grape Extract and Exercise Effects on Blood Pressure

U

University of Castilla-La Mancha

Status

Begins enrollment in 2 months

Conditions

Polyphenol
Blood Pressure Monitoring, Ambulatory
Exercise Response

Treatments

Dietary Supplement: Grape extract (VinteraTM Premium Red Grape)
Dietary Supplement: Control (placebo) group

Study type

Interventional

Funder types

Other

Identifiers

NCT06985407
POLYPHENOL-EXER-CARDIOVACULAR

Details and patient eligibility

About

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.

Enrollment

12 estimated patients

Sex

All

Ages

25 to 65 years old

Volunteers

No Healthy Volunteers

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)

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Single Blind

12 participants in 2 patient groups, including a placebo group

Grape extract (VinteraTM Premium Red Grape)
Experimental group
Treatment:
Dietary Supplement: Grape extract (VinteraTM Premium Red Grape)
Placebo
Placebo Comparator group
Treatment:
Dietary Supplement: Control (placebo) group

Trial contacts and locations

0

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Central trial contact

Felix Morales Palomo, PhD

Data sourced from clinicaltrials.gov

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