L-arginine Supplementation and Resistance Exercise

Sponsor
North Dakota State University (Other)
Overall Status
Completed
CT.gov ID
NCT03827005
Collaborator
(none)
30
2
10.4

Study Details

Study Description

Brief Summary

The purpose of this study was to examine the acute endothelial, cardiovascular, and performance responses to L-arginine by assessing flow-mediated dilation (FMD) and heart rate variability (HRV) both before and after resistance exercise to fatigue. Thirty (15 male, 15 female) physically active participants volunteered for a randomized, cross-over, double-blind, placebo- controlled clinical trial. Participants completed five sets of elbow extension-flexion exercise after consumption of either 3 g of placebo or 3 g L-arginine.

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: L-arginine
  • Dietary Supplement: Placebo
N/A

Detailed Description

Participants Thirty healthy, physically active males (n=15) and females (n=15), 18-25 years of age completed the study. Subjects had not participated in another clinical trial or consumed another study related investigation product within 30 days of enrollment. If a supplement containing L-arginine or other nitrate precursors was being taken, a three-week washout period was conducted before participation. All procedures were approved in advance by the North Dakota State University Institutional Review Board and written consent was obtained.

Protocol A randomized, double-blind, placebo-controlled research design was implemented for this investigation. Prior to the randomized testing sessions, participants completed a anthropometric measurements and familiarization session which included:: collection of participant age, height (Seca 213, Chino, CA), and body mass data (Detecto, Webb City, MO) and familiarization with the Biodex Dynamometer (Biodex Medical Systems, Shirley, NY), ultrasound (Philips Ultrasound, Bothell, WA), and electronic sphygmomanometer (Hokanson Rapid Cuff Inflation System, Bellevue, WA) procedures. Participants then reported to the laboratory for two testing sessions, each separated by at least a 48 hours washout period. Testing sessions were conducted at the same time of day to account for circadian variation. Participants entered the trial sessions on an 8-our fast, but were encouraged to arrive at the session well-hydrated. The participants were instructed not to exercise or consume caffeine 24 hours prior to trial time or use toothpaste, chewing gum, or mouthwash the morning of the trials, due to the possible effects on nitric oxide absorption. All females tested negative for pregnancy based on a urinary pregnancy test (Clinical Guard, Atlanta, GA) prior to each trial session. At the start of the trial, participants rested for 5 minutes while sitting.

Endothelial responses were measured by a technique termed flow mediated vasodilation (FMD) which assessed the maximal vasodilatory response to shear stress. FMD was measured in accordance with recommendations from the International Brachial Artery Reactivity Task Force. A Philips HD11XE ultrasound system (Philips, Amsterdam, NL) equipped with 2D imaging, color and spectral Doppler, and a high-frequency vascular transducer was used for the protocol. The participants laid supine with the right arm inside a pillow for a stabilizer. Probe placement was on the brachial artery, above the antecubital fossa in the longitudinal place. Continuous 2D imaging was used to take an initial brachial artery diameter for 10 seconds to determine the resting artery diameter (to cover the full cardiac cycle). Probe placement was outlined with a marker. A Hokanson E20 electronic sphygmomanometric cuff and rapid cuff inflation system (Bellevue, WA) was placed on the middle of the forearm and inflated to 50 mmHg above systolic blood pressure for five mins and cuff placement was marked with a marker. Upon release of the cuff, the ultrasound probe was placed in the same area in which the first measure was taken. A continuous 2D imaging was used from cuff release to 120 seconds post-release. The average of three diameters measured using RadiAnt DICOM software was used for determination of FMD (%), which was expressed as the change in post-stimulus diameter as a percentage of baseline diameter.

Measures of the cardiovascular system included heart rate variability (HRV). HRV were recorded using a Polar H7 Bluetooth strap (Polar, Bethpage, NY) combined Personal Pro Elite HRV smartphone application (elitehrv.com) over 5 min intervals then further analyzed with Kubios software using the "very low" artifact correction setting. HRV explored the differences in beat-to-beat intervals based on the time (milliseconds) between adjacent R to R (RR) peaks within a PQRST waveform. HRV provides a dynamic, sensitive meter of the balance or tone between the two branches of the autonomic nervous system, sympathetic (SNS) and parasympathetic (PNS), RMSSD and pNN50 are also the most commonly used HRV measures and were used in this study.

After baseline measurements were collected, the participants consumed either 6 capsules (3 g) of L-arginine (NOW Foods, Bloomingdale, IL) or 6 capsules of corn starch, placebo (3 g) which had an identical appearance (InHealth Specialty Pharmacy, Fargo, ND). Each supplement was consumed with 12 oz. of water. The participant then rested for 55 minutes to ensure enough time for digestion, absorption and availability. At 55 minutes post-supplementation, participants completed a 5 minutes warm up using a cycle ergometer (Monark 828E, Vansbro, SV). Sixty minutes post-supplementation, participants completed elbow flexion and extension exercise with their right arm on an isokinetic dynamometer to determine the elbow flexor and extensor peak torque.The exercise protocol, designed to induce fatigue, consisted of five sets of 10 maximal isokinetic extension repetitions of the elbow joint at 90º per second with 30 seconds of rest in between sets. Participants were instructed and encouraged to use full-force for all sets. Isometric peak torque was measured prior to and thirty seconds after exercise to determine the fatigue percentage. Dynamometer settings remained constant for each testing session as recorded during the anthropometric and familiarization session. At 10 minutes post-exercise, which was 120 minutes after supplement consumption, FMD and HRV were measured for the final time.

Study Design

Study Type:
Interventional
Actual Enrollment :
30 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Intervention Model Description:
double blind, placebo, controlled -cross overdouble blind, placebo, controlled -cross over
Masking:
Double (Participant, Investigator)
Masking Description:
blinding performed by co-investigator not involved with data collection
Primary Purpose:
Other
Official Title:
The Acute Effects of L-arginine Supplementation on Flow-mediated Dilation After Resistance Exercise to Fatigue
Actual Study Start Date :
Jul 16, 2016
Actual Primary Completion Date :
Apr 30, 2017
Actual Study Completion Date :
May 30, 2017

Arms and Interventions

Arm Intervention/Treatment
Placebo Comparator: placebo

3 grams cornstarch once per day for one day.

Dietary Supplement: L-arginine
NOW Foods, Bloomingdale, IL

Dietary Supplement: Placebo
InHealth Specialty Pharmacy, Fargo, ND
Other Names:
  • cornstarch
  • Experimental: L-arginine

    3 g L-arginine once per day for one day.

    Dietary Supplement: L-arginine
    NOW Foods, Bloomingdale, IL

    Dietary Supplement: Placebo
    InHealth Specialty Pharmacy, Fargo, ND
    Other Names:
  • cornstarch
  • Outcome Measures

    Primary Outcome Measures

    1. Change in Flow mediated dilation 120 seconds post-cuff release [Change from Baseline and 120 seconds]

      Flow mediated dilation was measured using a A Philips HD11XE ultrasound system (Philips, Amsterdam, NL) equipped with 2D imaging, color and spectral Doppler, and a high-frequency vascular transducer.

    2. Change in Heart Rate Variability 10 minutes after intervention [Change from Baseline and 10 minutes post-exercise]

      Hear rate variability was recorded using a Polar H7 Bluetooth strap (Polar, Bethpage, NY) combined Personal Pro Elite HRV smartphone application (elitehrv.com) over 5 minutes intervals then further analyzed with Kubios software

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 25 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • generally healthy

    • physically active

    Exclusion Criteria:
    • previous clinical trial

    • pregnancy

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • North Dakota State University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Kyle Hackney, Assistant Professor, North Dakota State University
    ClinicalTrials.gov Identifier:
    NCT03827005
    Other Study ID Numbers:
    • HE16235
    First Posted:
    Feb 1, 2019
    Last Update Posted:
    Feb 1, 2019
    Last Verified:
    Jan 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Kyle Hackney, Assistant Professor, North Dakota State University

    Study Results

    No Results Posted as of Feb 1, 2019