NCT03827005

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2016

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 16, 2016

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2017

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

July 1, 2018

Completed
7 months until next milestone

First Posted

Study publicly available on registry

February 1, 2019

Completed
Last Updated

February 1, 2019

Status Verified

January 1, 2019

Enrollment Period

10 months

First QC Date

July 1, 2018

Last Update Submit

January 30, 2019

Conditions

Keywords

L-arginineflow mediated dilationresistance exercise

Outcome Measures

Primary Outcomes (2)

  • Change in Flow mediated dilation 120 seconds post-cuff release

    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.

    Change from Baseline and 120 seconds

  • Change in Heart Rate Variability 10 minutes after intervention

    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

    Change from Baseline and 10 minutes post-exercise

Study Arms (2)

placebo

PLACEBO COMPARATOR

3 grams cornstarch once per day for one day.

Dietary Supplement: L-arginineDietary Supplement: Placebo

L-arginine

EXPERIMENTAL

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

Dietary Supplement: L-arginineDietary Supplement: Placebo

Interventions

L-arginineDIETARY_SUPPLEMENT

NOW Foods, Bloomingdale, IL

L-arginineplacebo
PlaceboDIETARY_SUPPLEMENT

InHealth Specialty Pharmacy, Fargo, ND

Also known as: cornstarch
L-arginineplacebo

Eligibility Criteria

Age18 Years - 25 Years
Sexall(Gender-based eligibility)
Gender Eligibility Detailsself reported
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • generally healthy
  • physically active

You may not qualify if:

  • previous clinical trial
  • pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (7)

  • 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.

    PMID: 22251130BACKGROUND
  • 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.

    PMID: 21395365BACKGROUND
  • 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.

    PMID: 25976309BACKGROUND
  • 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.

    PMID: 19056561BACKGROUND
  • 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.

    PMID: 19233305BACKGROUND
  • 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.

    PMID: 10442089BACKGROUND
  • 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.

    PMID: 19276857BACKGROUND

MeSH Terms

Interventions

ArginineStarch

Intervention Hierarchy (Ancestors)

Amino Acids, BasicAmino AcidsAmino Acids, Peptides, and ProteinsAmino Acids, DiaminoAmino Acids, EssentialGlucansBiopolymersPolymersMacromolecular SubstancesDietary CarbohydratesCarbohydratesPolysaccharides

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
blinding performed by co-investigator not involved with data collection
Purpose
OTHER
Intervention Model
CROSSOVER
Model Details: double blind, placebo, controlled -cross over
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

July 1, 2018

First Posted

February 1, 2019

Study Start

July 16, 2016

Primary Completion

April 30, 2017

Study Completion

May 30, 2017

Last Updated

February 1, 2019

Record last verified: 2019-01

Data Sharing

IPD Sharing
Will not share