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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04389060
• Other study ID #: 081-1819-EXP
• Status: Completed
• Phase: N/A
• Start date: March 1, 2019
• Est. completion date: March 1, 2020

Study information

• Verified date: May 2020
• Source: California Baptist University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: March 1, 2020
• Est. primary completion date: March 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 29 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity

Intervention

Dietary Supplement:
• Grape seed extract
Two capsule grape seed extract (total 600 mg)

Locations

Country	Name	City	State
United States	California Baptist University	Riverside	California

Sponsors (1)

Lead Sponsor	Collaborator
California Baptist University

Country where clinical trial is conducted

United States, 

Outcome

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