NCT05945771

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2022

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

May 1, 2022

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2022

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

July 3, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

July 14, 2023

Completed
Last Updated

July 14, 2023

Status Verified

July 1, 2023

Enrollment Period

4 months

First QC Date

July 3, 2023

Last Update Submit

July 12, 2023

Conditions

Outcome Measures

Primary Outcomes (7)

  • Systolic blood pressure (mmHg) by sphygmomanometer

    Measured from the brachial artery

    24 hours

  • Diastolic blood pressure (mmHg) by sphygmomanometer

    Measured from the brachial artery

    24 hours

  • Mean arterial pressure (mmHg)

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

    24 hours

  • Heart rate (bpm)

    measured using Physio Flow (non-invasive device)

    24 hours

  • Stroke volume (ml)

    measured using Physio Flow (non-invasive device)

    24 hours

  • Cardiac output (l/min)

    calculated: HR (bpm) x SV (ml)

    24 hours

  • Total peripheral resistance (mmHg/l/min)

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

    24 hours

Study Arms (2)

Randomized double blind grape seed extract design

ACTIVE COMPARATOR

Grape seed extract

Dietary Supplement: Grape seed extract

Control

PLACEBO COMPARATOR

Placebo (starch)

Dietary Supplement: Grape seed extract

Interventions

Grape seed extractDIETARY_SUPPLEMENT

Acute effect of dietary supplementation with GSE on hemodynamic responses during static exercise and muscle metaboreflex and during cycling exercise.

ControlRandomized double blind grape seed extract design

Eligibility Criteria

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

You may qualify if:

  • Healthy volunteers (SBP \< 120 mmHg, DBP \< 80 mmHg)

You may not qualify if:

  • cardiovascular and/or pulmonary disease,
  • musculoskeletal disorders
  • 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

    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

July 3, 2023

First Posted

July 14, 2023

Study Start

May 1, 2022

Primary Completion

August 31, 2022

Study Completion

August 31, 2022

Last Updated

July 14, 2023

Record last verified: 2023-07

Locations