Obesity Adult OnsetNCT04465110
Effects of Chronic Dietary Grape Seed Extract Supplementation on Aortic Stiffness and Hemodynamic Responses to Exercise in Obese Males
A study testing Grape Seed Extract in people with Obesity Adult Onset, run by California Baptist University at 1 site in United States.
Trial summary
It was demonstrated that acute dietary supplementation with GSE reduced arterial blood pressure via reduction in Q in obese individuals. However, no studies have investigated the chronic effects of dietary GSE supplementation on hemodynamic responses during exercise. 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 Adult Onset
- 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
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2019to 22 Apr 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
- Overweight: 25-29.9 kg/m2
- Obese: > 30 kg/m2
- Waist circumference: > 90 cm
Who cannot join
- Antihypertensive medication
- Major systemic disease (cancer)
- Musculoskeletal diseases
- Cardiovascular diseases or symptoms including chest pain
- Myocardial infarction
- Arrhythmias
- Heart failure
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 Chronic Dietary Grape Seed Extract Supplementation on Aortic Stiffness and Hemodynamic Responses in Obese/Overweight Males During Submaximal Exercise
It was demonstrated that acute dietary supplementation with GSE reduced arterial blood pressure via reduction in Q in obese individuals. However, no studies have investigated the chronic effects of dietary GSE supplementation on hemodynamic responses during exercise. Given the fact that obesity is associated with an impaired function of eNOS, the effect of chronic dietary GSE supplementation on abnormal blood pressure response to exercise and aortic stiffness (AoS) needs be elucidated. Thus, it is hypothesized that GSE decreases systolic blood pressure (SBP), diastolic blood pressure (DBP), mean arterial pressure (MAP), Q, and aortic stiffness at rest and during exercise. This study would determine that this supplementation may be used as a non-pharmacological intervention to prevent incident hypertension and cardiovascular events during exercise via enhanced endothelial function.
Read the detailed description
We investigated whether elevated blood pressure and aortic stiffness (AoS) characterized in obese and overweight males (N=10) are reduced following chronic GSE supplementation during exercise. Systolic blood pressure (SBP), diastolic blood pressure (DBP), mean arterial pressure (MAP), heart rate (HR), stroke volume (SV), cardiac output (Q), total vascular conductance (TVC), and AoS to two submaximal cycling exercises (40% and 60% VO2peak) were compared 7 days after ingestion of GSE or placebo (PL) within an one week washout period. Compared with PL, GSE supplementation significantly decreased MAP at rest, 40%, and 60% workloads. AoS was significantly reduced at rest. Q tended to be decreased, but there was no significant difference. GSE had no effect on HR, TVC, and SV. Our study indicates that chronic supplementation with GSE reduces arterial pressure at rest and during exercise primarily via the combined reduction of AoS and Q. Thus, GSE can be a dietary supplement to treat augmented blood pressure responses in obese and overweight males at rest and during exercise.
- Conditions
- Obesity Adult Onset
- 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
Subjects took a single dose of 600 mg GSE in capsule form through ingestion 2 hours prior to testing Dietary Supplement: Grape seed extract Two capsule grape seed extract (total 600 mg) per day
| Study group | Role | What they receive |
|---|---|---|
| GSE group | Experimental | Subjects took a single dose of 600 mg GSE in capsule form through ingestion 7 days Receives: Dietary Supplement: Grape Seed Extract |
| Placebo group | Placebo comparator | Subjects took a single dose of 600 mg starch in capsule form through ingestion 7 days 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 at rest and during exercise
beats per minute
Measured: 7 day supplementation
change in stroke volume at rest and during exercise
volume per stroke
Measured: 7 day supplementation
change in cardiac output at rest and during exercise
total volume for one minute
Measured: 7 day supplementation
change in systolic blood pressure at rest and during exercise
pressure exerted during contraction
Measured: 7 day supplementation
change in diastolic blood pressure at rest and during exercise
pressure exerted during relaxation
Measured: 7 day supplementation
change in total vascular conductance at rest and during exercise
one reported value (cardiac output/mean arterial pressure)
Measured: 7 day supplementation
change in aortic stiffness at rest
Arbitrary unit
Measured: 7 day supplementation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2020
- Study start1 Sep 2019
- Primary completion22 Apr 2020
- Study completion22 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Obesity Adult OnsetStudies 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
- 10 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
- NCT04465110
- Sponsor's protocol ID
- 109-1819-EXP
- Status last verified
- Jul 2020
- First submitted
- 6 Jul 2020
- Last updated
- 13 Jul 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: To determine the chronic effects of dietary grape seed extraction, all data collected at rest and during exercise will be shared with other researchers in the publication
Publications
Dillon K, Shariffi B, Gillum T, Boyer W, Sullivan S, Kim JK. Effects of chronic dietary grape seed extract supplementation on aortic stiffness and hemodynamic responses in obese/overweight males during submaximal exercise. Eur J Sport Sci. 2022 Jul;22(7):1057-1064. doi: 10.1080/17461391.2021.1923815. Epub 2021 May 20.
PubMed 33905304
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Chronic Dietary Grape Seed Extract Supplementation on Aortic Stiffness and Hemodynamic Responses in Obese/Overweight Males During Submaximal Exercise
- ClinicalTrials.gov ID
- NCT04465110
- Acronym / sponsor ID
- 109-1819-EXP
- Conditions
- Obesity Adult Onset
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- California Baptist UniversityUniversity, hospital or other
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 22 Apr 2020 (actual)
- Study completion
- 22 Apr 2020 (actual)
- First posted
- 9 Jul 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.
It was demonstrated that acute dietary supplementation with GSE reduced arterial blood pressure via reduction in Q in obese individuals. However, no studies have investigated the chronic effects of dietary GSE supplementation on hemodynamic responses during exercise. Given the fact that obesity is associated with an impaired function of eNOS, the effect of chronic dietary GSE supplementation on abnormal blood pressure response to exercise and aortic stiffness (AoS) needs be elucidated. Thus, it is hypothesized that GSE decreases systolic blood pressure (SBP), diastolic blood pressure (DBP), mean arterial pressure (MAP), Q, and aortic stiffness at rest and during exercise. This study would determine that this supplementation may be used as a non-pharmacological intervention to prevent incident hypertension and cardiovascular events during exercise via enhanced endothelial function.
Detailed description
We investigated whether elevated blood pressure and aortic stiffness (AoS) characterized in obese and overweight males (N=10) are reduced following chronic GSE supplementation during exercise. Systolic blood pressure (SBP), diastolic blood pressure (DBP), mean arterial pressure (MAP), heart rate (HR), stroke volume (SV), cardiac output (Q), total vascular conductance (TVC), and AoS to two submaximal cycling exercises (40% and 60% VO2peak) were compared 7 days after ingestion of GSE or placebo (PL) within an one week washout period. Compared with PL, GSE supplementation significantly decreased MAP at rest, 40%, and 60% workloads. AoS was significantly reduced at rest. Q tended to be decreased, but there was no significant difference. GSE had no effect on HR, TVC, and SV. Our study indicates that chronic supplementation with GSE reduces arterial pressure at rest and during exercise primarily via the combined reduction of AoS and Q. Thus, GSE can be a dietary supplement to treat augmented blood pressure responses in obese and overweight males at rest and during exercise.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GSE group | Experimental | Dietary Supplement: Grape Seed ExtractSubjects took a single dose of 600 mg GSE in capsule form through ingestion 7 days |
| Placebo group | Placebo comparator | Dietary Supplement: Grape Seed ExtractSubjects took a single dose of 600 mg starch in capsule form through ingestion 7 days |
Who may qualify
- Ages
- 18 to 29 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Overweight: 25-29.9 kg/m2
- Obese: > 30 kg/m2
- Waist circumference: > 90 cm
Key exclusion criteria (7 listed)
- Antihypertensive medication
- Major systemic disease (cancer)
- Musculoskeletal diseases
- Cardiovascular diseases or symptoms including chest pain
- Myocardial infarction
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 ExtractSubjects took a single dose of 600 mg GSE in capsule form through ingestion 2 hours prior to testing Dietary Supplement: Grape seed extract Two capsule grape seed extract (total 600 mg) per day | Dietary supplement | GSE group, Placebo group |
Primary outcome
change in heart rate at rest and during exercise
Time frame: 7 day supplementation
beats per minute
change in stroke volume at rest and during exercise
Time frame: 7 day supplementation
volume per stroke
change in cardiac output at rest and during exercise
Time frame: 7 day supplementation
total volume for one minute
change in systolic blood pressure at rest and during exercise
Time frame: 7 day supplementation
pressure exerted during contraction
change in diastolic blood pressure at rest and during exercise
Time frame: 7 day supplementation
pressure exerted during relaxation
change in total vascular conductance at rest and during exercise
Time frame: 7 day supplementation
one reported value (cardiac output/mean arterial pressure)
change in aortic stiffness at rest
Time frame: 7 day supplementation
Arbitrary unit
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 13 Jul 2020.
- Derived from this study: PubMed 33905304Dillon K, Shariffi B, Gillum T, Boyer W, Sullivan S, Kim JK. Effects of chronic dietary grape seed extract supplementation on aortic stiffness and hemodynamic responses in obese/overweight males during submaximal exercise. Eur J Sport Sci. 2022 Jul;22(7):1057-1064. doi: 10.1080/17461391.2021.1923815. Epub 2021 May 20.
- Individual participant dataSharing planned: Yes. To determine the chronic effects of dietary grape seed extraction, all data collected at rest and during exercise will be shared with other researchers in the publication
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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 Obesity Adult Onset, 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 3 inclusion and 7 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 13 Jul 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 at rest and during exercise (time frame: 7 day 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?
On the ClinicalTrials.gov record for NCT04465110, which also lists 1 linked publication.
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 13 Jul 2020.