Effects of Combined Grape Seed Extract and L-citrulline Supplementation on Hemodynamic Responses in Young Males

November 1, 2021 updated by: California Baptist University
This study was to examine the additive benefits with combined grape seed extract (GSE) and L-citrulline supplementation on hemodynamic responses to dynamic exercise, 11 young, healthy males were recruited for this study.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The investigators aimed the additive effects of combined grape seed extract (GSE) and L-citrulline supplementation on hemodynamic responses to dynamic exercise, 11 young, healthy males were recruited for this study. Effects of 7 days of combined GSE with L-citrulline supplementation on systolic blood pressure (SBP), diastolic blood pressure (DBP), mean arterial blood pressure (MAP), cardiac output (CO), total vascular conductance (TVC), and oxygen consumption (O2) were examined at rest and during cycling exercise.

Study Type

Interventional

Enrollment (Actual)

11

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

  • United States
    • 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

18 years to 30 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • healthy males

Exclusion Criteria:

  • cardiovascular and/or pulmonary disease, musculoskeletal disorders, or 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 see extract
Dietary supplement: Grape seed extract
Effects of 7 days of combined GSE with L-citrulline supplementation on hemodynamic responses at rest and during cycling exercise.
Dietary supplement: Placebo
Effects of 7 days of placebo supplementation on hemodynamic responses at rest and during cycling exercise.
Placebo Comparator: Randomized double blind placebo design
Placebo
Dietary supplement: Grape seed extract
Effects of 7 days of combined GSE with L-citrulline supplementation on hemodynamic responses at rest and during cycling exercise.
Dietary supplement: Placebo
Effects of 7 days of placebo supplementation on hemodynamic responses at rest and during cycling exercise.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Systolic blood pressure (mmHg)
Time Frame: 7 days
by sphygmomanometer
7 days
Diastolic blood pressure (mmHg)
Time Frame: 7 days
by sphygmomanometer
7 days
Mean arterial pressure (mmHg)
Time Frame: 7 days
calculated (MAP = (SBP-DBP)/3 + DBP
7 days
Heart rate (bpm)
Time Frame: 7 days
measured using Physio Flow (non-invasive device)
7 days
Stroke volume (ml)
Time Frame: 7 days
measured using Physio Flow (non-invasive device)
7 days
Cardiac output (l/min)
Time Frame: 7 days
calculated: HR (bpm) x SV (ml)
7 days
Total vascular conductance (ml/min/mmHg)
Time Frame: 7 days
calculated: CO (ml/min) / MAP (mmHg)
7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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)

June 1, 2019

Primary Completion (Actual)

December 1, 2019

Study Completion (Actual)

December 1, 2019

Study Registration Dates

First Submitted

October 19, 2021

First Submitted That Met QC Criteria

November 1, 2021

First Posted (Actual)

November 10, 2021

Study Record Updates

Last Update Posted (Actual)

November 10, 2021

Last Update Submitted That Met QC Criteria

November 1, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 112-1819 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

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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