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

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

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

Study Overview

• Status: Completed
• Conditions: Obesity
• Intervention / Treatment: Dietary supplement: Grape seed extract

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Riverside, California, United States, 92504
      • California Baptist University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 29 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: GSE group; Subjects took a single dose of 600 mg GSE in capsule form through ingestion 2 hours prior to testing	Dietary supplement: Grape seed extract; Two capsule grape seed extract (total 600 mg)
Placebo Comparator: Placebo group; Subjects took a single dose of 600 mg starch in capsule form through ingestion 2 hours prior to testing	Dietary supplement: Grape seed extract; Two capsule grape seed extract (total 600 mg)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
change in heart rate	beats per minute	2 hours after each supplementation
change in stroke volume	volume per stroke	2 hours after each supplementation
change in cardiac output	total volume for a minute	2 hours after each supplementation
change in systolic blood pressure	pressure exerted during contraction	2 hours after each supplementation
change in diastolic blood pressure	pressure exerted during relaxation	2 hours after each supplementation
change in mean arterial pressure	One reported pressure (systolic blood pressure-diastolic blood pressure)/3 + diastolic blood pressure	2 hours after each supplementation
change in total peripheral resistance	One reported value (mean arterial pressure/cardiac output)	2 hours after each supplementation

Collaborators and Investigators

• Sponsor: California Baptist University

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2019
• Primary Completion (Actual): March 1, 2020
• Study Completion (Actual): March 1, 2020

Study Registration Dates

• First Submitted: May 8, 2020
• First Submitted That Met QC Criteria: May 11, 2020
• First Posted (Actual): May 15, 2020

Study Record Updates

• Last Update Posted (Actual): May 15, 2020
• Last Update Submitted That Met QC Criteria: May 11, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Protective Agents; Antineoplastic Agents, Phytogenic; Antioxidants; Grape Seed Extract
• Other Study ID Numbers: 081-1819-EXP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No