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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05945771
Other study ID # 107-2122-EXP
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 1, 2022
Est. completion date August 31, 2022

Study information

Verified date July 2023
Source California Baptist University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The aim of this study was to determine whether grape seed extract (GSE) supplementation could reduce the blood pressure (BP) in response to static exercise and post exercise muscular ischemia (PEMI) in normotensive young adults. In 12 healthy subjects (7 male and 5 female, 24.6±3.4 yr), we compared acute effect of both GSE (600 mg) and placebo (PL: 600 mg) on changes from rest in systolic BP (SBP), diastolic BP (DBP), mean arterial pressure (MAP), heart rate (HR), stroke volume (SV), cardiac output (CO), and total peripheral resistance (TPR) during static exercise (SE) and PEMI. Subjects completed 2 min of SE at 30% of maximal voluntary contraction (MVC) followed by 2 min of PEMI.


Recruitment information / eligibility

Status Completed
Enrollment 12
Est. completion date August 31, 2022
Est. primary completion date August 31, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 30 Years
Eligibility Inclusion Criteria: - Healthy volunteers (SBP < 120 mmHg, DBP < 80 mmHg) Exclusion Criteria: - cardiovascular and/or pulmonary disease, - musculoskeletal disorders - medications that prevent the safe completion of the exercise protocol

Study Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
Grape seed extract
Acute effect of dietary supplementation with GSE on hemodynamic responses during static exercise and muscle metaboreflex and during cycling exercise.

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 Systolic blood pressure (mmHg) by sphygmomanometer Measured from the brachial artery 24 hours
Primary Diastolic blood pressure (mmHg) by sphygmomanometer Measured from the brachial artery 24 hours
Primary Mean arterial pressure (mmHg) calculated (MAP = (SBP-DBP)/3 + DBP 24 hours
Primary Heart rate (bpm) measured using Physio Flow (non-invasive device) 24 hours
Primary Stroke volume (ml) measured using Physio Flow (non-invasive device) 24 hours
Primary Cardiac output (l/min) calculated: HR (bpm) x SV (ml) 24 hours
Primary Total peripheral resistance (mmHg/l/min) calculated: MAP (mmHg) / CO (l/min) 24 hours
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