L-arginine Supplementation and Resistance Exercise

NCT ID: NCT03827005

Last Updated: 2019-02-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-07-16

Study Completion Date

2017-05-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Healthy Adult

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

double blind, placebo, controlled -cross over
Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Investigators
blinding performed by co-investigator not involved with data collection

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

placebo

3 grams cornstarch once per day for one day.

Group Type PLACEBO_COMPARATOR

L-arginine

Intervention Type DIETARY_SUPPLEMENT

NOW Foods, Bloomingdale, IL

Placebo

Intervention Type DIETARY_SUPPLEMENT

InHealth Specialty Pharmacy, Fargo, ND

L-arginine

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

Group Type EXPERIMENTAL

L-arginine

Intervention Type DIETARY_SUPPLEMENT

NOW Foods, Bloomingdale, IL

Placebo

Intervention Type DIETARY_SUPPLEMENT

InHealth Specialty Pharmacy, Fargo, ND

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

L-arginine

NOW Foods, Bloomingdale, IL

Intervention Type DIETARY_SUPPLEMENT

Placebo

InHealth Specialty Pharmacy, Fargo, ND

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

cornstarch

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* generally healthy
* physically active

Exclusion Criteria

* previous clinical trial
* pregnancy
Minimum Eligible Age

18 Years

Maximum Eligible Age

25 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

North Dakota State University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Kyle Hackney

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

References

Explore related publications, articles, or registry entries linked to this study.

Alvares TS, Conte CA, Paschoalin VM, Silva JT, Meirelles Cde M, Bhambhani YN, Gomes PS. Acute l-arginine supplementation increases muscle blood volume but not strength performance. Appl Physiol Nutr Metab. 2012 Feb;37(1):115-26. doi: 10.1139/h11-144. Epub 2012 Jan 17.

Reference Type BACKGROUND
PMID: 22251130 (View on PubMed)

Alvares TS, Meirelles CM, Bhambhani YN, Paschoalin VM, Gomes PS. L-Arginine as a potential ergogenic aid in healthy subjects. Sports Med. 2011 Mar 1;41(3):233-48. doi: 10.2165/11538590-000000000-00000.

Reference Type BACKGROUND
PMID: 21395365 (View on PubMed)

Bondonno CP, Croft KD, Hodgson JM. Dietary Nitrate, Nitric Oxide, and Cardiovascular Health. Crit Rev Food Sci Nutr. 2016 Sep 9;56(12):2036-52. doi: 10.1080/10408398.2013.811212.

Reference Type BACKGROUND
PMID: 25976309 (View on PubMed)

Bai Y, Sun L, Yang T, Sun K, Chen J, Hui R. Increase in fasting vascular endothelial function after short-term oral L-arginine is effective when baseline flow-mediated dilation is low: a meta-analysis of randomized controlled trials. Am J Clin Nutr. 2009 Jan;89(1):77-84. doi: 10.3945/ajcn.2008.26544. Epub 2008 Dec 3.

Reference Type BACKGROUND
PMID: 19056561 (View on PubMed)

Kapadia MR, Eng JW, Jiang Q, Stoyanovsky DA, Kibbe MR. Nitric oxide regulates the 26S proteasome in vascular smooth muscle cells. Nitric Oxide. 2009 Jun;20(4):279-88. doi: 10.1016/j.niox.2009.02.005. Epub 2009 Feb 20.

Reference Type BACKGROUND
PMID: 19233305 (View on PubMed)

Arnal JF, Dinh-Xuan AT, Pueyo M, Darblade B, Rami J. Endothelium-derived nitric oxide and vascular physiology and pathology. Cell Mol Life Sci. 1999 Jul;55(8-9):1078-87. doi: 10.1007/s000180050358.

Reference Type BACKGROUND
PMID: 10442089 (View on PubMed)

Fahs CA, Heffernan KS, Fernhall B. Hemodynamic and vascular response to resistance exercise with L-arginine. Med Sci Sports Exerc. 2009 Apr;41(4):773-9. doi: 10.1249/MSS.0b013e3181909d9d.

Reference Type BACKGROUND
PMID: 19276857 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

HE16235

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

L-citrulline Supplementation & Cold Exposure
NCT01462591 COMPLETED PHASE1/PHASE2