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OpenTrials
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NCT Number: NCT04389060

Effect of Acute Dietary Supplementation With Grape Seed Extract on Aortic Stiffness, Arterial Pressure, and Blood Vessel Dilation in Collegiate Obese Individuals at Rest

This study investigated if elevated BP and aortic stiffness characterized in obese individuals are attenuated following acute grape seed extract supplementation. It is hypothesized that acute dietary supplementation with grape seed extract attenuates aortic stiffness, systolic blood pressure, diastolic blood pressure, mean arterial pressure, and total peripheral resistance and these effects are partially due to reductions in peripheral vasoconstriction

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Key information

Conditions

Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–29 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

California Baptist University

Riverside, California, 92504, United States

About this study

Twenty men (obese = 10; normal body weight (NBW) = 10) participated in this study. Effects of placebo (PL: 600 mg) and GSE (600 mg) on systolic blood pressure (SBP), diastolic blood pressure (DBP), mean arterial pressure (MAP), heart rate (HR), stroke volume (SV), cardiac output (Q), total peripheral resistance (TPR), and AoS were compared 2 h after ingestion of GSE or PL on different days, one week apart. Arterial blood pressure was measured using a sphygmomanometer from a brachial artery at the level of the heart on chair. HR and SV were continuously measured using a non-invasive device (Physio Flow). CO was calculated by HR X SV. TPR was calculated by MAP/CO.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Obesity: body mass index (>30), Normal body weight: body mass index (25-29)

Exclusion criteria

  • cardiovascular diseases or consume any antihypertensive medication or supplementation that can affect blood pressure or aortic stiffness

Treatment and study plan

Grape seed extract

Dietary Supplement

Two capsule grape seed extract (total 600 mg)

Primary outcomes

  1. change in heart rate

    Time frame: 2 hours after each supplementation

    beats per minute

  2. change in stroke volume

    Time frame: 2 hours after each supplementation

    volume per stroke

  3. change in cardiac output

    Time frame: 2 hours after each supplementation

    total volume for a minute

  4. change in systolic blood pressure

    Time frame: 2 hours after each supplementation

    pressure exerted during contraction

  5. change in diastolic blood pressure

    Time frame: 2 hours after each supplementation

    pressure exerted during relaxation

  6. change in mean arterial pressure

    Time frame: 2 hours after each supplementation

    One reported pressure (systolic blood pressure-diastolic blood pressure)/3 + diastolic blood pressure

  7. change in total peripheral resistance

    Time frame: 2 hours after each supplementation

    One reported value (mean arterial pressure/cardiac output)

Sponsors and collaborators

Lead sponsor

California Baptist University

Other

Registry information

Official study title

Effects of Acute Grape Seed Extract Supplementation on Hemodynamics in Obese Males

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
May 15, 2020
Registry last updated
May 15, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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