Evaluation of Sports Supplements on Blood Flow
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ClinicalTrials.gov Identifier: NCT04278053 |
Recruitment Status :
Completed
First Posted : February 20, 2020
Last Update Posted : May 24, 2022
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Condition or disease | Intervention/treatment | Phase |
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Determine the Effects of Nitrosigine and Citrulline-malate on Flow-mediated Dilation Among Young Adults | Dietary Supplement: inositol-stabilized arginine silicate | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 24 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Intervention Model Description: | Randomized, double-blind, crossover design |
Masking: | Double (Participant, Investigator) |
Masking Description: | Both the participants and the researchers were blinded to the supplements until all data collection had been completed. |
Primary Purpose: | Other |
Official Title: | Effects of Nitrosigine on Flow-Mediated Dilation Among Young Adults |
Actual Study Start Date : | October 15, 2018 |
Actual Primary Completion Date : | May 8, 2019 |
Actual Study Completion Date : | May 8, 2019 |

Arm | Intervention/treatment |
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Experimental: Nitrosigine supplementation
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.
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Dietary Supplement: inositol-stabilized arginine silicate
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. |
Experimental: Citrulline-Malate supplementation
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.
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Dietary Supplement: inositol-stabilized arginine silicate
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. |
Placebo Comparator: Placebo
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.
|
Dietary Supplement: inositol-stabilized arginine silicate
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. |
- Vasodilation [ Time Frame: 60 minutes ]Amount of brachial vasodilation caused by supplementation as measured by flow-mediated dilation and ultrasound

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Ages Eligible for Study: | 18 Years to 29 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Healthy, regularly exercising young adults
Exclusion Criteria:
- hypertension, metabolic disorders, previous consumption of pre-workout supplements 6 months prior to study, prescriptions medications known to effect the vasodilatory response.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04278053
United States, Arkansas | |
University of Arkansas | |
Fayetteville, Arkansas, United States, 72701 |
Principal Investigator: | Michelle Gray, Ph.D | University of Arkansas |
Responsible Party: | Michelle Gray, Associate Professor - Exercise Science, University of Arkansas, Fayetteville |
ClinicalTrials.gov Identifier: | NCT04278053 |
Other Study ID Numbers: |
1812163576 |
First Posted: | February 20, 2020 Key Record Dates |
Last Update Posted: | May 24, 2022 |
Last Verified: | May 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
flow-mediated dilation vasodilation Nitrosigine Citrulline-Malate |
Dilatation, Pathologic Pathological Conditions, Anatomical Inositol Vitamin B Complex |
Vitamins Micronutrients Physiological Effects of Drugs |