NCT07137988

Brief Summary

This study hypothesized that sustained sympathoexcitation via MMA slows down PHRR and that GSE supplementation is effective at improving PHRR in young individuals. 12 Participants were randomly assigned, via a double-blind, cross-over design, to either receive GSE (300mg, 2 capsules) or PL (300mg, 2 capsules), with a washout period of at least 72 hrs. between trials. A submaximal exercise test was performed using a cycle ergometer combined with isometric handgrip exercise using a handgrip dynamometer, and blood flow occlusion by placing a cuff over the brachial artery of the dominant arm. Post heart rate recovery (PHRR) was measured at 5 sec. intervals throughout the experiment. The PHRR was evaluated between GSE and PL at every min. for 300 sec.

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 Oct 2024

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

October 3, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 3, 2024

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

August 15, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 22, 2025

Completed
Last Updated

August 22, 2025

Status Verified

August 1, 2025

Enrollment Period

2 months

First QC Date

August 15, 2025

Last Update Submit

August 15, 2025

Conditions

Keywords

Double blinded cross-over design

Outcome Measures

Primary Outcomes (1)

  • Heart rate recovery every minute and heart rate kinetics (tau) following exercise

    5 min after exercise

Study Arms (2)

Experimental: Heart rate recovery with grape seed extract

EXPERIMENTAL

Grape seed extract: 300 mg, two capsules Starch: 300 mg, two capsules

Dietary Supplement: 600 mg grape seed extractDietary Supplement: 600 mg Starch

Sham Comparator: Experimental: BFR exercise without histamine blockade

PLACEBO COMPARATOR

Heart rate recovery with placebo (starch, 300 mg, 2 capsules)

Dietary Supplement: 600 mg grape seed extractDietary Supplement: 600 mg Starch

Interventions

600 mg grape seed extractDIETARY_SUPPLEMENT

Each participant took either GSE (300 mg, 2 capsules) or a placebo (300 mg, 2 capsules filled with starch) 2 hours before their scheduled lab visit. The supplements were made to look identical to prevent any bias from the participants or the testers. There was a washout period of at least 72 hours, but no more than a week, between each trial.

Also known as: 600 mg starch
Experimental: Heart rate recovery with grape seed extractSham Comparator: Experimental: BFR exercise without histamine blockade
600 mg StarchDIETARY_SUPPLEMENT

Each participant took either GSE (300 mg, 2 capsules) or a placebo (300 mg, 2 capsules filled with starch) 2 hours before their scheduled lab visit. The supplements were made to look identical to prevent any bias from the participants or the testers. There was a washout period of at least 72 hours, but no more than a week, between each trial.

Experimental: Heart rate recovery with grape seed extractSham Comparator: Experimental: BFR exercise without histamine blockade

Eligibility Criteria

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

You may qualify if:

  • good health, nonsmokers, those not taking medications that could affect cardiovascular function

You may not qualify if:

  • hypertension, muscular skeletal disorders

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 ExtractStarch

Intervention Hierarchy (Ancestors)

Plant ExtractsPlant PreparationsBiological ProductsComplex MixturesPharmaceutical PreparationsGlucansBiopolymersPolymersMacromolecular SubstancesDietary CarbohydratesCarbohydratesPolysaccharides

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 15, 2025

First Posted

August 22, 2025

Study Start

October 3, 2024

Primary Completion

December 3, 2024

Study Completion

December 31, 2024

Last Updated

August 22, 2025

Record last verified: 2025-08

Locations