ObesityNCT04389060
Effect of Acute Dietary Supplementation With Grape Seed Extract on Aortic Stiffness, Arterial Pressure, and Blood Vessel Dilation in Collegiate Obese Individuals at Rest
A study testing Grape seed extract in people with Obesity, run by California Baptist University at 1 site in United States.
Trial summary
This study investigated if elevated BP and aortic stiffness characterized in obese individuals are attenuated following acute grape seed extract supplementation. It is hypothesized that acute dietary supplementation with grape seed extract attenuates aortic stiffness, systolic blood pressure, diastolic blood pressure… Read more about this study
- Who is it for?
- Ages 18 to 29 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity
- 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
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2019to 1 Mar 2020
- 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 29 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Obesity: body mass index (>30), Normal body weight: body mass index (25-29)
Who cannot join
- cardiovascular diseases or consume any antihypertensive medication or supplementation that can affect blood pressure or aortic stiffness
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 Hemodynamics in Obese Males
This study investigated if elevated BP and aortic stiffness characterized in obese individuals are attenuated following acute grape seed extract supplementation. It is hypothesized that acute dietary supplementation with grape seed extract attenuates aortic stiffness, systolic blood pressure, diastolic blood pressure, mean arterial pressure, and total peripheral resistance and these effects are partially due to reductions in peripheral vasoconstriction
Read the detailed description
Twenty men (obese = 10; normal body weight (NBW) = 10) participated in this study. Effects of placebo (PL: 600 mg) and GSE (600 mg) on systolic blood pressure (SBP), diastolic blood pressure (DBP), mean arterial pressure (MAP), heart rate (HR), stroke volume (SV), cardiac output (Q), total peripheral resistance (TPR), and AoS were compared 2 h after ingestion of GSE or PL on different days, one week apart. Arterial blood pressure was measured using a sphygmomanometer from a brachial artery at the level of the heart on chair. HR and SV were continuously measured using a non-invasive device (Physio Flow). CO was calculated by HR X SV. TPR was calculated by MAP/CO.
- Conditions
- Obesity
- Being tested
- Grape seed extract
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Grape seed extractDietary supplement
Two capsule grape seed extract (total 600 mg)
| Study group | Role | What they receive |
|---|---|---|
| GSE group | Active comparator | Subjects took a single dose of 600 mg GSE in capsule form through ingestion 2 hours prior to testing Receives: Dietary Supplement: Grape seed extract |
| Placebo group | Placebo comparator | Subjects took a single dose of 600 mg starch in capsule form through ingestion 2 hours prior to testing Receives: Dietary Supplement: Grape seed extract |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in heart rate
beats per minute
Measured: 2 hours after each supplementation
change in stroke volume
volume per stroke
Measured: 2 hours after each supplementation
change in cardiac output
total volume for a minute
Measured: 2 hours after each supplementation
change in systolic blood pressure
pressure exerted during contraction
Measured: 2 hours after each supplementation
change in diastolic blood pressure
pressure exerted during relaxation
Measured: 2 hours after each supplementation
change in mean arterial pressure
One reported pressure (systolic blood pressure-diastolic blood pressure)/3 + diastolic blood pressure
Measured: 2 hours after each supplementation
change in total peripheral resistance
One reported value (mean arterial pressure/cardiac output)
Measured: 2 hours after each supplementation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2020
- Study start1 Mar 2019
- Primary completion1 Mar 2020
- Study completion1 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies 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
- 20 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
- NCT04389060
- Sponsor's protocol ID
- 081-1819-EXP
- Status last verified
- May 2020
- First submitted
- 8 May 2020
- Last updated
- 15 May 2020
- 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 15 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Acute Grape Seed Extract Supplementation on Hemodynamics in Obese Males
- ClinicalTrials.gov ID
- NCT04389060
- Acronym / sponsor ID
- 081-1819-EXP
- Conditions
- Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- California Baptist UniversityUniversity, hospital or other
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 1 Mar 2020 (actual)
- Study completion
- 1 Mar 2020 (actual)
- First posted
- 15 May 2020 (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 investigated if elevated BP and aortic stiffness characterized in obese individuals are attenuated following acute grape seed extract supplementation. It is hypothesized that acute dietary supplementation with grape seed extract attenuates aortic stiffness, systolic blood pressure, diastolic blood pressure, mean arterial pressure, and total peripheral resistance and these effects are partially due to reductions in peripheral vasoconstriction
Detailed description
Twenty men (obese = 10; normal body weight (NBW) = 10) participated in this study. Effects of placebo (PL: 600 mg) and GSE (600 mg) on systolic blood pressure (SBP), diastolic blood pressure (DBP), mean arterial pressure (MAP), heart rate (HR), stroke volume (SV), cardiac output (Q), total peripheral resistance (TPR), and AoS were compared 2 h after ingestion of GSE or PL on different days, one week apart. Arterial blood pressure was measured using a sphygmomanometer from a brachial artery at the level of the heart on chair. HR and SV were continuously measured using a non-invasive device (Physio Flow). CO was calculated by HR X SV. TPR was calculated by MAP/CO.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GSE group | Active comparator | Dietary Supplement: Grape seed extractSubjects took a single dose of 600 mg GSE in capsule form through ingestion 2 hours prior to testing |
| Placebo group | Placebo comparator | Dietary Supplement: Grape seed extractSubjects took a single dose of 600 mg starch in capsule form through ingestion 2 hours prior to testing |
Who may qualify
- Ages
- 18 to 29 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Obesity: body mass index (>30), Normal body weight: body mass index (25-29)
Key exclusion criteria (1 listed)
- cardiovascular diseases or consume any antihypertensive medication or supplementation that can affect blood pressure or aortic stiffness
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 extractTwo capsule grape seed extract (total 600 mg) | Dietary supplement | GSE group, Placebo group |
Primary outcome
change in heart rate
Time frame: 2 hours after each supplementation
beats per minute
change in stroke volume
Time frame: 2 hours after each supplementation
volume per stroke
change in cardiac output
Time frame: 2 hours after each supplementation
total volume for a minute
change in systolic blood pressure
Time frame: 2 hours after each supplementation
pressure exerted during contraction
change in diastolic blood pressure
Time frame: 2 hours after each supplementation
pressure exerted during relaxation
change in mean arterial pressure
Time frame: 2 hours after each supplementation
One reported pressure (systolic blood pressure-diastolic blood pressure)/3 + diastolic blood pressure
change in total peripheral resistance
Time frame: 2 hours after each supplementation
One reported value (mean arterial pressure/cardiac output)
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 15 May 2020.
- 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 Grape seed extract in people with Obesity, 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 15 May 2020. 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?
change in heart rate (time frame: 2 hours after each supplementation). 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 15 May 2020.