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

Sponsor

California Baptist University (Other)

Overall Status

Completed

CT.gov ID

NCT05116150

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

1.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

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

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 Design

Study Type:

Interventional

Actual Enrollment :

11 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Jun 1, 2019

Actual Primary Completion Date :

Dec 1, 2019

Actual Study Completion Date :

Dec 1, 2019

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 30 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

healthy males

Exclusion Criteria:

cardiovascular and/or pulmonary disease, musculoskeletal disorders, or medications that prevent the safe completion of the exercise protocol

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

Principal Investigator: Jong-Kyung Kim, Ph.D, California Baptist University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

California Baptist University

ClinicalTrials.gov Identifier:

NCT05116150

Other Study ID Numbers:

112-1819 EXP

First Posted:

Nov 10, 2021

Last Update Posted:

Nov 10, 2021

Last Verified:

Nov 1, 2021

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 Nov 10, 2021