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

Sponsor

California Baptist University (Other)

Overall Status

Completed

CT.gov ID

NCT04389060

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

1.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Obesity	Dietary Supplement: Grape seed extract	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

20 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Double (Participant, Investigator)

Masking Description:

Double blind, cross-over design

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Mar 1, 2019

Actual Primary Completion Date :

Mar 1, 2020

Actual Study Completion Date :

Mar 1, 2020

Arms and Interventions

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)

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)

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 29 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	California Baptist University	Riverside	California	United States	92504

Sponsors and Collaborators

California Baptist University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Jong-Kyung Kim, Associate Professor, California Baptist University

ClinicalTrials.gov Identifier:

NCT04389060

Other Study ID Numbers:

081-1819-EXP

First Posted:

May 15, 2020

Last Update Posted:

May 15, 2020

Last Verified:

May 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Grape Seed Extract

Study Results

No Results Posted as of May 15, 2020