NCT06428890

Brief Summary

This study aimed to assess the effect of the supplementation with grape seed extract (GSE) on blood pressure during static handgrip exercise and muscle metaboreflex in individuals with elevated and state 1 hypertension.

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 Mar 2022

Typical duration 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

March 1, 2022

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2024

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 15, 2024

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 24, 2024

Completed
Last Updated

May 24, 2024

Status Verified

May 1, 2024

Enrollment Period

2.1 years

First QC Date

May 15, 2024

Last Update Submit

May 20, 2024

Conditions

Outcome Measures

Primary Outcomes (6)

  • heart rate (bpm)

    measured these variables at rest and during static handgrip exercise and muscle metaboreflex

    5 minutes, 3 minutes, and 2 minutes, respectively.

  • stroke volume (ml)

    measured these variables at rest and during static handgrip exercise and muscle metaboreflex

    5 minutes, 3 minutes, and 2 minutes, respectively.

  • cardiac output (l/min)

    measured these variables at rest and during static handgrip exercise and muscle metaboreflex

    5 minutes, 3 minutes, and 2 minutes, respectively.

  • systolic blood pressure (mmHg)

    measured these variables at rest and during static handgrip exercise and muscle metaboreflex

    5 minutes, 3 minutes, and 2 minutes, respectively.

  • diastolic blood pressure (mmHg)

    measured these variables at rest and during static handgrip exercise and muscle metaboreflex

    5 minutes, 3 minutes, and 2 minutes, respectively.

  • total peripheral resistance (mmHg/l/min)

    measured these variables at rest and during static handgrip exercise and muscle metaboreflex

    5 minutes, 3 minutes, and 2 minutes, respectively.

Study Arms (2)

Dietary Supplementation with Grape Seed Extract

EXPERIMENTAL

Participants received the supplement (600 mg, capsules) via cross-over design for 7 days

Dietary Supplement: Grape Seed ExtractDietary Supplement: Placebo

Placebo

PLACEBO COMPARATOR

Participants received the placebo (600 mg, capsules) via cross-over design for 7 days

Dietary Supplement: Grape Seed ExtractDietary Supplement: Placebo

Interventions

Grape Seed ExtractDIETARY_SUPPLEMENT

dietary supplements that rich in polyphenolic compounds

Dietary Supplementation with Grape Seed ExtractPlacebo
PlaceboDIETARY_SUPPLEMENT

Starch

Dietary Supplementation with Grape Seed ExtractPlacebo

Eligibility Criteria

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

You may qualify if:

  • systolic blood pressure: 120-139 mmHg and/or a diastolic blood pressure: 80-89 mmHg

You may not qualify if:

  • taking medications that could affect cardiovascular function or BP

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

California Baptist University

Riverside, California, 92504, United States

Location

MeSH Terms

Conditions

Prehypertension

Interventions

Grape Seed Extract

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

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
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 15, 2024

First Posted

May 24, 2024

Study Start

March 1, 2022

Primary Completion

April 1, 2024

Study Completion

April 1, 2024

Last Updated

May 24, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

This study needs the Institutional Research Board (IRB) and participant's approvals to share the data. Without the approval, the data collected from this study will not be shared.

Locations