PrehypertensionNCT06428890
Effect of 7 Days of Grape Seed Extract Supplementation on Cold Pressor Test and Muscle Metaboreflex in Individuals With Elevated and Stage 1 Hypertension
A study testing Grape Seed Extract in people with Prehypertension, run by California Baptist University at 1 site in United States.
Trial 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. 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
- Prehypertension
- What is being tested?
- Grape Seed Extract
- 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
- 1 Mar 2022to 1 Apr 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
- systolic blood pressure: 120-139 mmHg and/or a diastolic blood pressure: 80-89 mmHg
Who cannot join
- taking medications that could affect cardiovascular function or BP
Trial locations and contacts
1 site in 1 country.
United States1 site
California Baptist University
Riverside, California, 92504
About this study
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.
Read the detailed description
Muscle metatoreflex (MMR) has been known to play an important role in adjusting hemodynamic responses during exercise. The reflex increases sympathetic activity to heart and blood vessels to increase blood supply to contracting skeletal muscles. On the other hand, studies demonstrated that abnormal cardiovascular responses occurred by the overactive MMR in pathological conditions such as hypertension, diabetes, and congestive heart failure. Excessive blood pressure (BP) responses to exercise induce cardiovascular events such as stroke, heart attack, and coronary artery disease. Previously, a study found that dietary supplementation with grape seed extract (GSE) reduced BP response to dynamic exercise in individuals with elevated and stage 1 hypertension (ES1H) and associated with peripheral vasodilation. However, mechanisms underlying this phenomenon are not clear. Purpose: therefore, the purpose of this study is to investigate whether chronic dietary supplementation with GSE can decrease BP responses to exercise and this observation is associated with reduced MMR. Methods: 12 ES1H males were studied. Changes in cardiac output (Q), mean arterial pressure (MAP) and total peripheral resistance (TPR) were compared between the GSE and placebo supplementations during static handgrip exercise (SHE) and post exercise muscular ischemia (PEMI). Participants completed 3 min of SHE at 40% of MVC followed by 2 min of PEMI.
- Conditions
- Prehypertension
- Being tested
- Grape Seed Extract, Placebo
- Medical subject headings
- Prehypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Grape Seed ExtractDietary supplement
dietary supplements that rich in polyphenolic compounds
PlaceboDietary supplement
Starch
| Study group | Role | What they receive |
|---|---|---|
| Dietary Supplementation with Grape Seed Extract | Experimental | Participants received the supplement (600 mg, capsules) via cross-over design for 7 days Receives: Dietary Supplement: Grape Seed Extract; Dietary Supplement: Placebo |
| Placebo | Placebo comparator | Participants received the placebo (600 mg, capsules) via cross-over design for 7 days Receives: Dietary Supplement: Grape Seed Extract; Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
heart rate (bpm)
measured these variables at rest and during static handgrip exercise and muscle metaboreflex
Measured: 5 minutes, 3 minutes, and 2 minutes, respectively.
stroke volume (ml)
measured these variables at rest and during static handgrip exercise and muscle metaboreflex
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 5 minutes, 3 minutes, and 2 minutes, respectively.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2024
- Study start1 Mar 2022
- Primary completion1 Apr 2024
- Study completion1 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PrehypertensionStudies 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
- Basic science
- 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, Ph.D., Principal investigator, California Baptist University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06428890
- Sponsor's protocol ID
- 030-2223-EXP
- Status last verified
- May 2024
- First submitted
- 15 May 2024
- Last updated
- 24 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of 7 Days of Grape Seed Extract Supplementation on Cold Pressor Test and Muscle Metaboreflex in Individuals With Elevated and Stage 1 Hypertension
- ClinicalTrials.gov ID
- NCT06428890
- Acronym / sponsor ID
- 030-2223-EXP
- Conditions
- Prehypertension
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- California Baptist UniversityUniversity, hospital or other
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 1 Apr 2024 (actual)
- Study completion
- 1 Apr 2024 (actual)
- First posted
- 24 May 2024 (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 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.
Detailed description
Muscle metatoreflex (MMR) has been known to play an important role in adjusting hemodynamic responses during exercise. The reflex increases sympathetic activity to heart and blood vessels to increase blood supply to contracting skeletal muscles. On the other hand, studies demonstrated that abnormal cardiovascular responses occurred by the overactive MMR in pathological conditions such as hypertension, diabetes, and congestive heart failure. Excessive blood pressure (BP) responses to exercise induce cardiovascular events such as stroke, heart attack, and coronary artery disease. Previously, a study found that dietary supplementation with grape seed extract (GSE) reduced BP response to dynamic exercise in individuals with elevated and stage 1 hypertension (ES1H) and associated with peripheral vasodilation. However, mechanisms underlying this phenomenon are not clear. Purpose: therefore, the purpose of this study is to investigate whether chronic dietary supplementation with GSE can decrease BP responses to exercise and this observation is associated with reduced MMR. Methods: 12 ES1H males were studied. Changes in cardiac output (Q), mean arterial pressure (MAP) and total peripheral resistance (TPR) were compared between the GSE and placebo supplementations during static handgrip exercise (SHE) and post exercise muscular ischemia (PEMI). Participants completed 3 min of SHE at 40% of MVC followed by 2 min of PEMI.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dietary Supplementation with Grape Seed Extract | Experimental | Dietary Supplement: Grape Seed Extract, Dietary Supplement: PlaceboParticipants received the supplement (600 mg, capsules) via cross-over design for 7 days |
| Placebo | Placebo comparator | Dietary Supplement: Grape Seed Extract, Dietary Supplement: PlaceboParticipants received the placebo (600 mg, capsules) via cross-over design for 7 days |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- systolic blood pressure: 120-139 mmHg and/or a diastolic blood pressure: 80-89 mmHg
Key exclusion criteria (1 listed)
- taking medications that could affect cardiovascular function or BP
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 Extractdietary supplements that rich in polyphenolic compounds | Dietary supplement | Dietary Supplementation with Grape Seed Extract, Placebo |
| PlaceboStarch | Dietary supplement | Dietary Supplementation with Grape Seed Extract, Placebo |
Primary outcome
heart rate (bpm)
Time frame: 5 minutes, 3 minutes, and 2 minutes, respectively.
measured these variables at rest and during static handgrip exercise and muscle metaboreflex
stroke volume (ml)
Time frame: 5 minutes, 3 minutes, and 2 minutes, respectively.
measured these variables at rest and during static handgrip exercise and muscle metaboreflex
cardiac output (l/min)
Time frame: 5 minutes, 3 minutes, and 2 minutes, respectively.
measured these variables at rest and during static handgrip exercise and muscle metaboreflex
systolic blood pressure (mmHg)
Time frame: 5 minutes, 3 minutes, and 2 minutes, respectively.
measured these variables at rest and during static handgrip exercise and muscle metaboreflex
diastolic blood pressure (mmHg)
Time frame: 5 minutes, 3 minutes, and 2 minutes, respectively.
measured these variables at rest and during static handgrip exercise and muscle metaboreflex
total peripheral resistance (mmHg/l/min)
Time frame: 5 minutes, 3 minutes, and 2 minutes, respectively.
measured these variables at rest and during static handgrip exercise and muscle metaboreflex
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 24 May 2024.
- Individual participant dataSharing planned: No. 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.
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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, Ph.D. 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 Prehypertension, 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 24 May 2024. 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 (bpm) (time frame: 5 minutes, 3 minutes, and 2 minutes, respectively.). The study lists 6 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 24 May 2024.