NCT05116150

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
11

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2019

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

October 19, 2021

Completed
22 days until next milestone

First Posted

Study publicly available on registry

November 10, 2021

Completed
Last Updated

November 10, 2021

Status Verified

November 1, 2021

Enrollment Period

6 months

First QC Date

October 19, 2021

Last Update Submit

November 1, 2021

Conditions

Dietary Supplementation

Outcome Measures

Primary Outcomes (7)

  • Systolic blood pressure (mmHg)

    by sphygmomanometer

    7 days

  • Diastolic blood pressure (mmHg)

    by sphygmomanometer

    7 days

  • Mean arterial pressure (mmHg)

    calculated (MAP = (SBP-DBP)/3 + DBP

    7 days

  • Heart rate (bpm)

    measured using Physio Flow (non-invasive device)

    7 days

  • Stroke volume (ml)

    measured using Physio Flow (non-invasive device)

    7 days

  • Cardiac output (l/min)

    calculated: HR (bpm) x SV (ml)

    7 days

  • Total vascular conductance (ml/min/mmHg)

    calculated: CO (ml/min) / MAP (mmHg)

    7 days

Study Arms (2)

Randomized double blind grape seed extract design

ACTIVE COMPARATOR

Grape see extract

Dietary Supplement: Grape seed extractDietary Supplement: Placebo

Randomized double blind placebo design

PLACEBO COMPARATOR

Placebo

Dietary Supplement: Grape seed extractDietary Supplement: Placebo

Interventions

Grape seed extractDIETARY_SUPPLEMENT

Effects of 7 days of combined GSE with L-citrulline supplementation on hemodynamic responses at rest and during cycling exercise.

Randomized double blind grape seed extract designRandomized double blind placebo design
PlaceboDIETARY_SUPPLEMENT

Effects of 7 days of placebo supplementation on hemodynamic responses at rest and during cycling exercise.

Randomized double blind grape seed extract designRandomized double blind placebo design

Eligibility Criteria

Age18 Years - 30 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • healthy males

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

California Baptist University

Riverside, California, 92504, United States

Location

MeSH Terms

Interventions

Grape Seed Extract

Intervention Hierarchy (Ancestors)

Plant ExtractsPlant PreparationsBiological ProductsComplex MixturesPharmaceutical Preparations

Study Officials

  • Jong-Kyung Kim, Ph.D

    California Baptist University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 19, 2021

First Posted

November 10, 2021

Study Start

June 1, 2019

Primary Completion

December 1, 2019

Study Completion

December 1, 2019

Last Updated

November 10, 2021

Record last verified: 2021-11

Locations

US(1)