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Evaluation of Sports Supplements on Blood Flow

Primary Purpose

Determine the Effects of Nitrosigine and Citrulline-malate on Flow-mediated Dilation Among Young Adults

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
inositol-stabilized arginine silicate
Sponsored by
University of Arkansas, Fayetteville
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Determine the Effects of Nitrosigine and Citrulline-malate on Flow-mediated Dilation Among Young Adults focused on measuring flow-mediated dilation, vasodilation, Nitrosigine, Citrulline-Malate

Eligibility Criteria

18 Years - 29 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • University of Arkansas

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Nitrosigine supplementation

Citrulline-Malate supplementation

Placebo

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

Vasodilation
Amount of brachial vasodilation caused by supplementation as measured by flow-mediated dilation and ultrasound

Secondary Outcome Measures

Full Information

First Posted
February 18, 2020
Last Updated
May 17, 2022
Sponsor
University of Arkansas, Fayetteville
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1. Study Identification

Unique Protocol Identification Number
NCT04278053
Brief Title
Evaluation of Sports Supplements on Blood Flow
Official Title
Effects of Nitrosigine on Flow-Mediated Dilation Among Young Adults
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
October 15, 2018 (Actual)
Primary Completion Date
May 8, 2019 (Actual)
Study Completion Date
May 8, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Arkansas, Fayetteville

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Determine the Effects of Nitrosigine and Citrulline-malate on Flow-mediated Dilation Among Young Adults
Keywords
flow-mediated dilation, vasodilation, Nitrosigine, Citrulline-Malate

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Randomized, double-blind, crossover design
Masking
ParticipantInvestigator
Masking Description
Both the participants and the researchers were blinded to the supplements until all data collection had been completed.
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Nitrosigine supplementation
Arm Type
Experimental
Arm Description
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.
Arm Title
Citrulline-Malate supplementation
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
inositol-stabilized arginine silicate
Intervention Description
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.
Primary Outcome Measure Information:
Title
Vasodilation
Description
Amount of brachial vasodilation caused by supplementation as measured by flow-mediated dilation and ultrasound
Time Frame
60 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
29 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michelle Gray, Ph.D
Organizational Affiliation
University of Arkansas
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Arkansas
City
Fayetteville
State/Province
Arkansas
ZIP/Postal Code
72701
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Evaluation of Sports Supplements on Blood Flow

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