Determine the Effects of Nitrosigine and Citrulline-malate on Flow-mediated Dilation Among Young AdultsNCT04278053
Evaluation of Sports Supplements on Blood Flow
A study testing inositol-stabilized arginine silicate in people with Determine the Effects of Nitrosigine and Citrulline-malate on Flow-mediated Dilation Among Young Adults, run by University of Arkansas, Fayetteville at 1 site in United States.
Trial summary
Many athletes seek to increase their plasma (blood) nitric oxide content prior to exercise in order to augment vasodilation. Increased vasodilation during exercise, especially high intensity resistance training, allows for more blood flow to muscle tissues, which may give the athlete benefits such as increased work… Read more about this study
- Who is it for?
- Ages 18 to 29 yearsHealthy volunteers can take part
- Conditions the study is for
- Determine the Effects of Nitrosigine and Citrulline-malate on Flow-mediated Dilation Among Young Adults
- What is being tested?
- inositol-stabilized arginine silicate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Oct 2018to 8 May 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 29 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy, regularly exercising young adults
Who cannot join
- hypertension, metabolic disorders, previous consumption of pre-workout supplements 6 months prior to study, prescriptions medications known to effect the vasodilatory response.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Arkansas
Fayetteville, Arkansas, 72701
About this study
Official title: Effects of Nitrosigine on Flow-Mediated Dilation Among Young Adults
Many athletes seek to increase their plasma (blood) nitric oxide content prior to exercise in order to augment vasodilation. Increased vasodilation during exercise, especially high intensity resistance training, allows for more blood flow to muscle tissues, which may give the athlete benefits such as increased work capacity and acute muscle hyperemia, which is commonly referred to as muscle pump. Pre-workout supplements are typically taken 30 minutes to 1 hour prior to the onset of exercise, so the current investigation seeks to determine if citrulline malate or nitrosigine can effect vasodilation within 1 hour of supplementation, and if so, which supplement is more effective. Based on previous findings, we hypothesize that a certain exercise intensity needs to be present for citrulline malate and nitrosigine to have an effect, so a change may not be observable at rest.
Read the detailed description
Data collection will be conducted by qualified research staff and students at the University of Arkansas Exercise Science Research Center (ESRC). Upon contact with the research team, a medical/health questionnaire will be sent via email to the subject. This will be the initial screening tool to determine if the subject qualifies for the project. The subjects must meet the inclusion and none of the exclusion criteria in order to qualify for the study. Participants will be instructed to do the following the day of data collection: 1. No caffeine, stimulants, or blood thinners (such as ibuprofen, advil, aspirin, warfarin, clopidogrel, etc.) 24 hours prior to testing. 2. Wear comfortable clothes (short sleeve top). 3. Take all medication as normal (aside from those mentioned in #1). Participant testing will be conducted as follows: participant arrives at ESRC; height, weight, blood pressure, and complete questionnaires (electronically): medical history, 24-hour dietary recall, International Physical Activity Questionnaire (IPAQ). IPAQ is a standardized questionnaire used to evaluate an individual's level of physical activity in their daily life. After completing all surveys, the subject will be asked to lie in a supine position for 15 minutes, then they will have the diameter of the brachial artery (medial side of upper arm) assessed with ultrasound (GE Logiq e). Ultrasound is a non-invasive way of determining the diameter of arteries. A total of 10 measurements will be taken of the brachial artery. After the initial 10 measurements (~3-5 minutes), flow-mediated dilation (FMD) will be performed. Flow mediated dilation will be performed with a Hokanson rapid cuff inflator. The cuff (blood pressure cuff) will be position on the forearm (just above the wrist) and will be inflated to 250-300mmHg for a period of 5 minutes to restrict blood flow. After the 5-minute inflation period, the cuff will deflate and vessel diameter will be re-assessed (10 additional trails). Following the initial FMD assessment, one of three supplements will be consumed: citrulline-malate (8 g), Nitrosigine (1.5 g), or placebo (8 g Dextrose). After consumption, participants will remain in ESRC for 60 minutes to allow for digestion of the substance. Following the 60-minute absorption period, FMD will be re-assessed.
- Being tested
- inositol-stabilized arginine silicate
- Keywords
- flow-mediated dilation, vasodilation, Nitrosigine, Citrulline-Malate
- Medical subject headings
- Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
inositol-stabilized arginine silicateDietary supplement
Participants were asked to complete the experimental protocol in a 2-hour fasted state. Each participant's brachial artery FMD was assessed twice during each trial, once before supplement ingestion, and again 60 minutes post-ingestion. Male participants were required to wait for a minimum of seven days between trials as a supplement washout period. Female participants reported for supplement trials outside of their follicular phase of the menstrual cycle so that results were not confounded by changes in serum estradiol, which can significantly attenuate flow-mediated dilation. Sixty minutes after supplement consumption, each participant was asked which supplement they thought they had consumed. Participants were also asked whether they experienced any adverse side effects.
| Study group | Role | What they receive |
|---|---|---|
| Nitrosigine supplementation | Experimental | Ultrasound is a non-invasive way of determining the diameter of arteries. A total of 10 measurements will be taken of the brachial artery. After the initial 10 measurements (~3-5 minutes), flow-mediated dilation (FMD) was performed. Flow mediated dilation was performed with a Hokanson rapid cuff inflator. The cuff (blood pressure cuff) was position on the forearm (just above the wrist) and was inflated to 250-300mmHg for a period of 5 minutes to restrict blood flow. After the 5-minute inflation period, the cuff was deflated and vessel diameter was re-assessed (10 additional trails). Following the initial FMD assessment, Nitrosigine (1.5 g) was provided in an 8 ounce solution with a cherry flavoring to mask taste. After consumption, participants remained in ESRC for 60 minutes to allow for digestion of the substance. Following the 60-minute absorption period, FMD was re-assessed. Receives: Dietary Supplement: inositol-stabilized arginine silicate |
| Citrulline-Malate supplementation | Experimental | Ultrasound is a non-invasive way of determining the diameter of arteries. A total of 10 measurements will be taken of the brachial artery. After the initial 10 measurements (~3-5 minutes), flow-mediated dilation (FMD) was performed. Flow mediated dilation was performed with a Hokanson rapid cuff inflator. The cuff (blood pressure cuff) was position on the forearm (just above the wrist) and was inflated to 250-300mmHg for a period of 5 minutes to restrict blood flow. After the 5-minute inflation period, the cuff was deflated and vessel diameter was re-assessed (10 additional trails). Following the initial FMD assessment, Citrulline-Malate (8 g) was provided in an 8 ounce solution with a cherry flavoring to mask taste. After consumption, participants remained in ESRC for 60 minutes to allow for digestion of the substance. Following the 60-minute absorption period, FMD was re-assessed. Receives: Dietary Supplement: inositol-stabilized arginine silicate |
| Placebo | Placebo comparator | Ultrasound is a non-invasive way of determining the diameter of arteries. A total of 10 measurements will be taken of the brachial artery. After the initial 10 measurements (~3-5 minutes), flow-mediated dilation (FMD) was performed. Flow mediated dilation was performed with a Hokanson rapid cuff inflator. The cuff (blood pressure cuff) was position on the forearm (just above the wrist) and was inflated to 250-300mmHg for a period of 5 minutes to restrict blood flow. After the 5-minute inflation period, the cuff was deflated and vessel diameter was re-assessed (10 additional trails). Following the initial FMD assessment, dextrose (8 g) was provided in an 8 ounce solution with a cherry flavoring to mask taste. After consumption, participants remained in ESRC for 60 minutes to allow for digestion of the substance. Following the 60-minute absorption period, FMD was re-assessed. Receives: Dietary Supplement: inositol-stabilized arginine silicate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vasodilation
Amount of brachial vasodilation caused by supplementation as measured by flow-mediated dilation and ultrasound
Measured: 60 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2020
- Study start15 Oct 2018
- Primary completion8 May 2019
- Study completion8 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Determine the Effects of Nitrosigine and Citrulline-malate on Flow-mediated Dilation Among Young AdultsStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Randomized, double-blind, crossover design
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Arkansas, Fayetteville
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michelle Gray, University of Arkansas, Fayetteville
- Investigators
- Michelle Gray, Ph.D, Principal investigator, University of Arkansas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04278053
- Sponsor's protocol ID
- 1812163576
- Status last verified
- May 2022
- First submitted
- 18 Feb 2020
- Last updated
- 24 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Nitrosigine on Flow-Mediated Dilation Among Young Adults
- ClinicalTrials.gov ID
- NCT04278053
- Acronym / sponsor ID
- 1812163576
- Keywords
- flow-mediated dilation, vasodilation, Nitrosigine, Citrulline-Malate
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of Arkansas, FayettevilleUniversity, hospital or other
- Study start
- 15 Oct 2018 (actual)
- Primary completion
- 8 May 2019 (actual)
- Study completion
- 8 May 2019 (actual)
- First posted
- 20 Feb 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.
Many athletes seek to increase their plasma (blood) nitric oxide content prior to exercise in order to augment vasodilation. Increased vasodilation during exercise, especially high intensity resistance training, allows for more blood flow to muscle tissues, which may give the athlete benefits such as increased work capacity and acute muscle hyperemia, which is commonly referred to as muscle pump. Pre-workout supplements are typically taken 30 minutes to 1 hour prior to the onset of exercise, so the current investigation seeks to determine if citrulline malate or nitrosigine can effect vasodilation within 1 hour of supplementation, and if so, which supplement is more effective. Based on previous findings, we hypothesize that a certain exercise intensity needs to be present for citrulline malate and nitrosigine to have an effect, so a change may not be observable at rest.
Detailed description
Data collection will be conducted by qualified research staff and students at the University of Arkansas Exercise Science Research Center (ESRC). Upon contact with the research team, a medical/health questionnaire will be sent via email to the subject. This will be the initial screening tool to determine if the subject qualifies for the project. The subjects must meet the inclusion and none of the exclusion criteria in order to qualify for the study. Participants will be instructed to do the following the day of data collection: 1. No caffeine, stimulants, or blood thinners (such as ibuprofen, advil, aspirin, warfarin, clopidogrel, etc.) 24 hours prior to testing. 2. Wear comfortable clothes (short sleeve top). 3. Take all medication as normal (aside from those mentioned in #1). Participant testing will be conducted as follows: participant arrives at ESRC; height, weight, blood pressure, and complete questionnaires (electronically): medical history, 24-hour dietary recall, International Physical Activity Questionnaire (IPAQ). IPAQ is a standardized questionnaire used to evaluate an individual's level of physical activity in their daily life. After completing all surveys, the subject will be asked to lie in a supine position for 15 minutes, then they will have the diameter of the brachial artery (medial side of upper arm) assessed with ultrasound (GE Logiq e). Ultrasound is a non-invasive way of determining the diameter of arteries. A total of 10 measurements will be taken of the brachial artery. After the initial 10 measurements (~3-5 minutes), flow-mediated dilation (FMD) will be performed. Flow mediated dilation will be performed with a Hokanson rapid cuff inflator. The cuff (blood pressure cuff) will be position on the forearm (just above the wrist) and will be inflated to 250-300mmHg for a period of 5 minutes to restrict blood flow. After the 5-minute inflation period, the cuff will deflate and vessel diameter will be re-assessed (10 additional trails). Following the initial FMD assessment, one of three supplements will be consumed: citrulline-malate (8 g), Nitrosigine (1.5 g), or placebo (8 g Dextrose). After consumption, participants will remain in ESRC for 60 minutes to allow for digestion of the substance. Following the 60-minute absorption period, FMD will be re-assessed.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- Model description
- Randomized, double-blind, crossover design
| Arm | Type | Receives |
|---|---|---|
| Nitrosigine supplementation | Experimental | Dietary Supplement: inositol-stabilized arginine silicateUltrasound is a non-invasive way of determining the diameter of arteries. A total of 10 measurements will be taken of the brachial artery. After the initial 10 measurements (~3-5 minutes), flow-mediated dilation (FMD) was performed. Flow mediated dilation was performed with a Hokanson rapid cuff inflator. The cuff (blood pressure cuff) was position on the forearm (just above the wrist) and was inflated to 250-300mmHg for a period of 5 minutes to restrict blood flow. After the 5-minute inflation period, the cuff was deflated and vessel diameter was re-assessed (10 additional trails). Following the initial FMD assessment, Nitrosigine (1.5 g) was provided in an 8 ounce solution with a cherry flavoring to mask taste. After consumption, participants remained in ESRC for 60 minutes to allow for digestion of the substance. Following the 60-minute absorption period, FMD was re-assessed. |
| Citrulline-Malate supplementation | Experimental | Dietary Supplement: inositol-stabilized arginine silicateUltrasound is a non-invasive way of determining the diameter of arteries. A total of 10 measurements will be taken of the brachial artery. After the initial 10 measurements (~3-5 minutes), flow-mediated dilation (FMD) was performed. Flow mediated dilation was performed with a Hokanson rapid cuff inflator. The cuff (blood pressure cuff) was position on the forearm (just above the wrist) and was inflated to 250-300mmHg for a period of 5 minutes to restrict blood flow. After the 5-minute inflation period, the cuff was deflated and vessel diameter was re-assessed (10 additional trails). Following the initial FMD assessment, Citrulline-Malate (8 g) was provided in an 8 ounce solution with a cherry flavoring to mask taste. After consumption, participants remained in ESRC for 60 minutes to allow for digestion of the substance. Following the 60-minute absorption period, FMD was re-assessed. |
| Placebo | Placebo comparator | Dietary Supplement: inositol-stabilized arginine silicateUltrasound is a non-invasive way of determining the diameter of arteries. A total of 10 measurements will be taken of the brachial artery. After the initial 10 measurements (~3-5 minutes), flow-mediated dilation (FMD) was performed. Flow mediated dilation was performed with a Hokanson rapid cuff inflator. The cuff (blood pressure cuff) was position on the forearm (just above the wrist) and was inflated to 250-300mmHg for a period of 5 minutes to restrict blood flow. After the 5-minute inflation period, the cuff was deflated and vessel diameter was re-assessed (10 additional trails). Following the initial FMD assessment, dextrose (8 g) was provided in an 8 ounce solution with a cherry flavoring to mask taste. After consumption, participants remained in ESRC for 60 minutes to allow for digestion of the substance. Following the 60-minute absorption period, FMD was re-assessed. |
Who may qualify
- Ages
- 18 to 29 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy, regularly exercising young adults
Key exclusion criteria (1 listed)
- hypertension, metabolic disorders, previous consumption of pre-workout supplements 6 months prior to study, prescriptions medications known to effect the vasodilatory response.
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 |
|---|---|---|
| inositol-stabilized arginine silicateParticipants were asked to complete the experimental protocol in a 2-hour fasted state. Each participant's brachial artery FMD was assessed twice during each trial, once before supplement ingestion, and again 60 minutes post-ingestion. Male participants were required to wait for a minimum of seven days between trials as a supplement washout period. Female participants reported for supplement trials outside of their follicular phase of the menstrual cycle so that results were not confounded by changes in serum estradiol, which can significantly attenuate flow-mediated dilation. Sixty minutes after supplement consumption, each participant was asked which supplement they thought they had consumed. Participants were also asked whether they experienced any adverse side effects. | Dietary supplement | Citrulline-Malate supplementation, Nitrosigine supplementation, Placebo |
Primary outcome
Vasodilation
Time frame: 60 minutes
Amount of brachial vasodilation caused by supplementation as measured by flow-mediated dilation and ultrasound
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 2022.
- Individual participant dataSharing planned: No
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.
Michelle Gray, Ph.D principal investigator
University of Arkansas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing inositol-stabilized arginine silicate in people with Determine the Effects of Nitrosigine and Citrulline-malate on Flow-mediated Dilation Among Young Adults, run by University of Arkansas, Fayetteville 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 2022. 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?
Vasodilation (time frame: 60 minutes). 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 2022.