- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05945771
Effects of Acute Grape Seed Extract Supplementation on Muscle Metaboreflex in Healthy Young Individuals
July 12, 2023 updated by: California Baptist University
Effects of Acute Grape Seed Extract Supplementation on Muscle Metaboreflex in Healthy
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
12
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
Riverside, California, United States, 92504
- California Baptist University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Yes
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Randomized double blind grape seed extract design
Grape seed extract
|
Acute effect of dietary supplementation with GSE on hemodynamic responses during static exercise and muscle metaboreflex and during cycling exercise.
|
Placebo Comparator: Control
Placebo (starch)
|
Acute effect of dietary supplementation with GSE on hemodynamic responses during static exercise and muscle metaboreflex and during cycling exercise.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Systolic blood pressure (mmHg) by sphygmomanometer
Time Frame: 24 hours
|
Measured from the brachial artery
|
24 hours
|
Diastolic blood pressure (mmHg) by sphygmomanometer
Time Frame: 24 hours
|
Measured from the brachial artery
|
24 hours
|
Mean arterial pressure (mmHg)
Time Frame: 24 hours
|
calculated (MAP = (SBP-DBP)/3 + DBP
|
24 hours
|
Heart rate (bpm)
Time Frame: 24 hours
|
measured using Physio Flow (non-invasive device)
|
24 hours
|
Stroke volume (ml)
Time Frame: 24 hours
|
measured using Physio Flow (non-invasive device)
|
24 hours
|
Cardiac output (l/min)
Time Frame: 24 hours
|
calculated: HR (bpm) x SV (ml)
|
24 hours
|
Total peripheral resistance (mmHg/l/min)
Time Frame: 24 hours
|
calculated: MAP (mmHg) / CO (l/min)
|
24 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Jong-Kyung Kim, California Baptist University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 1, 2022
Primary Completion (Actual)
August 31, 2022
Study Completion (Actual)
August 31, 2022
Study Registration Dates
First Submitted
July 3, 2023
First Submitted That Met QC Criteria
July 12, 2023
First Posted (Actual)
July 14, 2023
Study Record Updates
Last Update Posted (Actual)
July 14, 2023
Last Update Submitted That Met QC Criteria
July 12, 2023
Last Verified
July 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 107-2122-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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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