Dietary SupplementationNCT05945771
Effects of Acute Grape Seed Extract Supplementation on Muscle Metaboreflex in Healthy Young Individuals
A study testing Grape seed extract in people with Dietary Supplementation, run by California Baptist University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Dietary Supplementation
- What is being tested?
- Grape seed extract
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2022to 31 Aug 2022
- 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
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy volunteers (SBP < 120 mmHg, DBP < 80 mmHg)
Who cannot join
- cardiovascular and/or pulmonary disease,
- musculoskeletal disorders
- medications that prevent the safe completion of the exercise protocol
Trial locations and contacts
1 site in 1 country.
United States1 site
California Baptist University
Riverside, California, 92504
About this study
Official title: Effects of Acute Grape Seed Extract Supplementation on Muscle Metaboreflex in Healthy
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.
- Conditions
- Dietary Supplementation
- Being tested
- Grape seed extract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Grape seed extractDietary supplement
Acute effect of dietary supplementation with GSE on hemodynamic responses during static exercise and muscle metaboreflex and during cycling exercise.
| Study group | Role | What they receive |
|---|---|---|
| Randomized double blind grape seed extract design | Active comparator | Grape seed extract Receives: Dietary Supplement: Grape seed extract |
| Control | Placebo comparator | Placebo (starch) Receives: Dietary Supplement: Grape seed extract |
What is being measured
The primary outcome is the main question the study is designed to answer.
Systolic blood pressure (mmHg) by sphygmomanometer
Measured from the brachial artery
Measured: 24 hours
Diastolic blood pressure (mmHg) by sphygmomanometer
Measured from the brachial artery
Measured: 24 hours
Mean arterial pressure (mmHg)
calculated (MAP = (SBP-DBP)/3 + DBP
Measured: 24 hours
Heart rate (bpm)
measured using Physio Flow (non-invasive device)
Measured: 24 hours
Stroke volume (ml)
measured using Physio Flow (non-invasive device)
Measured: 24 hours
Cardiac output (l/min)
calculated: HR (bpm) x SV (ml)
Measured: 24 hours
Total peripheral resistance (mmHg/l/min)
calculated: MAP (mmHg) / CO (l/min)
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2023
- Study start1 May 2022
- Primary completion31 Aug 2022
- Study completion31 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dietary SupplementationStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- California Baptist University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jong-Kyung Kim, Principal investigator, California Baptist University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05945771
- Sponsor's protocol ID
- 107-2122-EXP
- Status last verified
- Jul 2023
- First submitted
- 3 Jul 2023
- Last updated
- 14 Jul 2023
- Results posted
- No
- Data monitoring committee
- 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 14 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Acute Grape Seed Extract Supplementation on Muscle Metaboreflex in Healthy
- ClinicalTrials.gov ID
- NCT05945771
- Acronym / sponsor ID
- 107-2122-EXP
- Conditions
- Dietary Supplementation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- California Baptist UniversityUniversity, hospital or other
- Study start
- 1 May 2022 (actual)
- Primary completion
- 31 Aug 2022 (actual)
- Study completion
- 31 Aug 2022 (actual)
- First posted
- 14 Jul 2023 (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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Randomized double blind grape seed extract design | Active comparator | Dietary Supplement: Grape seed extractGrape seed extract |
| Control | Placebo comparator | Dietary Supplement: Grape seed extractPlacebo (starch) |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy volunteers (SBP < 120 mmHg, DBP < 80 mmHg)
Key exclusion criteria (3 listed)
- cardiovascular and/or pulmonary disease,
- musculoskeletal disorders
- medications that prevent the safe completion of the exercise protocol
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 |
|---|---|---|
| Grape seed extractAcute effect of dietary supplementation with GSE on hemodynamic responses during static exercise and muscle metaboreflex and during cycling exercise. | Dietary supplement | Control, Randomized double blind grape seed extract design |
Primary outcome
Systolic blood pressure (mmHg) by sphygmomanometer
Time frame: 24 hours
Measured from the brachial artery
Diastolic blood pressure (mmHg) by sphygmomanometer
Time frame: 24 hours
Measured from the brachial artery
Mean arterial pressure (mmHg)
Time frame: 24 hours
calculated (MAP = (SBP-DBP)/3 + DBP
Heart rate (bpm)
Time frame: 24 hours
measured using Physio Flow (non-invasive device)
Stroke volume (ml)
Time frame: 24 hours
measured using Physio Flow (non-invasive device)
Cardiac output (l/min)
Time frame: 24 hours
calculated: HR (bpm) x SV (ml)
Total peripheral resistance (mmHg/l/min)
Time frame: 24 hours
calculated: MAP (mmHg) / CO (l/min)
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 14 Jul 2023.
- 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.
Jong-Kyung Kim principal investigator
California Baptist University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Grape seed extract in people with Dietary Supplementation, 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 3 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 14 Jul 2023. 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?
Systolic blood pressure (mmHg) by sphygmomanometer (time frame: 24 hours). The study lists 7 primary outcomes in all. 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 14 Jul 2023.