Dietary SupplementationNCT05116150
Effects of Combined Grape Seed Extract and L-citrulline Supplementation on Hemodynamic Responses in Young Males
A study testing Grape seed extract in people with Dietary Supplementation, run by California Baptist University at 1 site in United States.
Trial summary
This study was to examine the additive benefits with combined grape seed extract (GSE) and L-citrulline supplementation on hemodynamic responses to dynamic exercise, 11 young, healthy males were recruited for this study. 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
- Dietary Supplementation
- What is being tested?
- Grape seed extract
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2019to 1 Dec 2019
- 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
- healthy males
Who cannot join
- cardiovascular and/or pulmonary disease, musculoskeletal disorders, or 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
This study was to examine the additive benefits with combined grape seed extract (GSE) and L-citrulline supplementation on hemodynamic responses to dynamic exercise, 11 young, healthy males were recruited for this study.
Read the detailed description
The investigators aimed the additive effects of combined grape seed extract (GSE) and L-citrulline supplementation on hemodynamic responses to dynamic exercise, 11 young, healthy males were recruited for this study. Effects of 7 days of combined GSE with L-citrulline supplementation on systolic blood pressure (SBP), diastolic blood pressure (DBP), mean arterial blood pressure (MAP), cardiac output (CO), total vascular conductance (TVC), and oxygen consumption (O2) were examined at rest and during cycling exercise.
- Conditions
- Dietary Supplementation
- Being tested
- Grape seed extract, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Grape seed extractDietary supplement
Effects of 7 days of combined GSE with L-citrulline supplementation on hemodynamic responses at rest and during cycling exercise.
PlaceboDietary supplement
Effects of 7 days of placebo supplementation on hemodynamic responses at rest and during cycling exercise.
| Study group | Role | What they receive |
|---|---|---|
| Randomized double blind grape seed extract design | Active comparator | Grape see extract Receives: Dietary Supplement: Grape seed extract; Dietary Supplement: Placebo |
| Randomized double blind placebo design | Placebo comparator | Placebo 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.
Systolic blood pressure (mmHg)
by sphygmomanometer
Measured: 7 days
Diastolic blood pressure (mmHg)
by sphygmomanometer
Measured: 7 days
Mean arterial pressure (mmHg)
calculated (MAP = (SBP-DBP)/3 + DBP
Measured: 7 days
Heart rate (bpm)
measured using Physio Flow (non-invasive device)
Measured: 7 days
Stroke volume (ml)
measured using Physio Flow (non-invasive device)
Measured: 7 days
Cardiac output (l/min)
calculated: HR (bpm) x SV (ml)
Measured: 7 days
Total vascular conductance (ml/min/mmHg)
calculated: CO (ml/min) / MAP (mmHg)
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2021
- Study start1 Jun 2019
- Primary completion1 Dec 2019
- Study completion1 Dec 2019
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
- 11 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
- NCT05116150
- Sponsor's protocol ID
- 112-1819 EXP
- Status last verified
- Nov 2021
- First submitted
- 19 Oct 2021
- Last updated
- 10 Nov 2021
- 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 10 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Combined Grape Seed Extract and L-citrulline Supplementation on Hemodynamic Responses in Young Males
- ClinicalTrials.gov ID
- NCT05116150
- Acronym / sponsor ID
- 112-1819 EXP
- Conditions
- Dietary Supplementation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- California Baptist UniversityUniversity, hospital or other
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- 1 Dec 2019 (actual)
- Study completion
- 1 Dec 2019 (actual)
- First posted
- 10 Nov 2021 (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 was to examine the additive benefits with combined grape seed extract (GSE) and L-citrulline supplementation on hemodynamic responses to dynamic exercise, 11 young, healthy males were recruited for this study.
Detailed description
The investigators aimed the additive effects of combined grape seed extract (GSE) and L-citrulline supplementation on hemodynamic responses to dynamic exercise, 11 young, healthy males were recruited for this study. Effects of 7 days of combined GSE with L-citrulline supplementation on systolic blood pressure (SBP), diastolic blood pressure (DBP), mean arterial blood pressure (MAP), cardiac output (CO), total vascular conductance (TVC), and oxygen consumption (O2) were examined at rest and during cycling exercise.
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 extract, Dietary Supplement: PlaceboGrape see extract |
| Randomized double blind placebo design | Placebo comparator | Dietary Supplement: Grape seed extract, Dietary Supplement: PlaceboPlacebo |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- healthy males
Key exclusion criteria (1 listed)
- cardiovascular and/or pulmonary disease, musculoskeletal disorders, or 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 extractEffects of 7 days of combined GSE with L-citrulline supplementation on hemodynamic responses at rest and during cycling exercise. | Dietary supplement | Randomized double blind grape seed extract design, Randomized double blind placebo design |
| PlaceboEffects of 7 days of placebo supplementation on hemodynamic responses at rest and during cycling exercise. | Dietary supplement | Randomized double blind grape seed extract design, Randomized double blind placebo design |
Primary outcome
Systolic blood pressure (mmHg)
Time frame: 7 days
by sphygmomanometer
Diastolic blood pressure (mmHg)
Time frame: 7 days
by sphygmomanometer
Mean arterial pressure (mmHg)
Time frame: 7 days
calculated (MAP = (SBP-DBP)/3 + DBP
Heart rate (bpm)
Time frame: 7 days
measured using Physio Flow (non-invasive device)
Stroke volume (ml)
Time frame: 7 days
measured using Physio Flow (non-invasive device)
Cardiac output (l/min)
Time frame: 7 days
calculated: HR (bpm) x SV (ml)
Total vascular conductance (ml/min/mmHg)
Time frame: 7 days
calculated: CO (ml/min) / MAP (mmHg)
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 10 Nov 2021.
- 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, 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 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 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 10 Nov 2021. 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) (time frame: 7 days). 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 10 Nov 2021.