Healthy Young MenNCT07137988
Effect of Acute Grape Seed Extract Supplementation on the Heart Rate Recovery in Young Individuals
A study testing 600 mg grape seed extract and 600 mg Starch in people with Healthy Young Men, run by California Baptist University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 30 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Young Men
- What is being tested?
- 600 mg grape seed extract and 600 mg Starch
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Oct 2024to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- good health, nonsmokers, those not taking medications that could affect cardiovascular function
Who cannot join
- hypertension, muscular skeletal disorders
Trial locations and contacts
1 site in 1 country.
United States1 site
California Baptist University
Riverside, California, 92504
About this study
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.
- Conditions
- Healthy Young Men
- Being tested
- 600 mg grape seed extract, 600 mg Starch
- Keywords
- Double blinded cross-over design
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
600 mg grape seed extractDietary supplement
Also called 600 mg starch
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Heart rate recovery with grape seed extract | Experimental | Grape seed extract: 300 mg, two capsules Starch: 300 mg, two capsules Receives: Dietary Supplement: 600 mg grape seed extract; Dietary Supplement: 600 mg Starch |
| Sham Comparator: Experimental: BFR exercise without histamine blockade | Placebo comparator | Heart rate recovery with placebo (starch, 300 mg, 2 capsules) Receives: Dietary Supplement: 600 mg grape seed extract; Dietary Supplement: 600 mg Starch |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart rate recovery every minute and heart rate kinetics (tau) following exercise
Measured: 5 min after exercise
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2025
- Study start3 Oct 2024
- Primary completion3 Dec 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Young MenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- California Baptist University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jong-Kyung Kim, California Baptist University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07137988
- Sponsor's protocol ID
- 034-2425-EXP
- Status last verified
- Aug 2025
- First submitted
- 15 Aug 2025
- Last updated
- 22 Aug 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Acute Grape Seed Extract Supplementation on the Heart Rate Recovery in Young Individuals
- ClinicalTrials.gov ID
- NCT07137988
- Acronym / sponsor ID
- 034-2425-EXP
- Conditions
- Healthy Young Men
- Keywords
- Double blinded cross-over design
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- California Baptist UniversityUniversity, hospital or other
- Study start
- 3 Oct 2024 (actual)
- Primary completion
- 3 Dec 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 22 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental: Heart rate recovery with grape seed extract | Experimental | Dietary Supplement: 600 mg grape seed extract, Dietary Supplement: 600 mg StarchGrape seed extract: 300 mg, two capsules Starch: 300 mg, two capsules |
| Sham Comparator: Experimental: BFR exercise without histamine blockade | Placebo comparator | Dietary Supplement: 600 mg grape seed extract, Dietary Supplement: 600 mg StarchHeart rate recovery with placebo (starch, 300 mg, 2 capsules) |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- good health, nonsmokers, those not taking medications that could affect cardiovascular function
Key exclusion criteria (1 listed)
- hypertension, muscular skeletal disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 600 mg grape seed extractAlso: 600 mg starchEach 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. | Dietary supplement | Experimental: Heart rate recovery with grape seed extract, Sham Comparator: Experimental: BFR exercise without histamine blockade |
| 600 mg StarchEach 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. | Dietary supplement | Experimental: Heart rate recovery with grape seed extract, Sham Comparator: Experimental: BFR exercise without histamine blockade |
Primary outcome
Heart rate recovery every minute and heart rate kinetics (tau) following exercise
Time frame: 5 min after exercise
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 600 mg grape seed extract and 600 mg Starch in people with Healthy Young Men, run by California Baptist University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Heart rate recovery every minute and heart rate kinetics (tau) following exercise (time frame: 5 min after exercise). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2025.