NCT02850367

Brief Summary

NO is an ubiquitous molecule contributing to many physiological functions such as vasodilation, immune and oxidative stress responses. NO production can be supplemented either by providing substrate to the NO-synthase (L-Arginine and L-Citruline) or by providing nitrate which can lead to NO. In the present project the investigators evaluate the effect of various acute and chronic oral NO precursors supplementation on exercise performance and responses in healthy young and older subjects.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
63

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

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

May 9, 2016

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

May 18, 2016

Completed
3 months until next milestone

First Posted

Study publicly available on registry

August 1, 2016

Completed
5.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2021

Completed
Last Updated

December 29, 2025

Status Verified

December 1, 2025

Enrollment Period

5.3 years

First QC Date

May 18, 2016

Last Update Submit

December 19, 2025

Conditions

Outcome Measures

Primary Outcomes (2)

  • Neuromuscular evaluations

    After the intake of the supplement. Measure the stretching force in the ankle (N)

    3 half days

  • Evaluation of post-ischemic vascular reactivity

    After the intake of the supplement. Concentration of hemoglobin (g/mL) in the quadriceps with the device : NIRS system Oxymon, ARTINIS.

    3 half days

Study Arms (2)

Acute intake

ACTIVE COMPARATOR

Evaluation after acute intake of the food supplement.

Dietary Supplement: NitrateDietary Supplement: Nitrate and L-ArginineDietary Supplement: Nitrate and L-CitrullineDietary Supplement: PlaceboBiological: Evaluation of post-ischemic vascular reactivityBiological: Neuromuscular evaluations

Chronic intake

ACTIVE COMPARATOR

Evaluation before and after chronic intake of the food supplement.

Dietary Supplement: Nitrate and L-CitrullineDietary Supplement: PlaceboBiological: Evaluation of post-ischemic vascular reactivityBiological: Neuromuscular evaluations

Interventions

After the intake of the supplement. Concentration of hemoglobin (g/mL) in the quadriceps with the device : NIRS system Oxymon, ARTINIS.

Acute intakeChronic intake
NitrateDIETARY_SUPPLEMENT

Subjects will be supplemented orally either acutely or chronically (4-8 weeks) with NO precursors.

Acute intake
Nitrate and L-ArginineDIETARY_SUPPLEMENT

Subjects will be supplemented orally either acutely or chronically (4-8 weeks) with NO precursors.

Acute intake
Nitrate and L-CitrullineDIETARY_SUPPLEMENT

Subjects will be supplemented orally either acutely or chronically (4-8 weeks) with NO precursors.

Acute intakeChronic intake
PlaceboDIETARY_SUPPLEMENT

Subjects will be supplemented orally either acutely or chronically (4-8 weeks) with a placebo.

Acute intakeChronic intake

After the intake of the supplement. Measure the stretching force in the ankle (N)

Acute intakeChronic intake

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Sedentary subjects
  • No cardiovascular, respiratory, metabolic and neurological disorders

You may not qualify if:

  • Body mass index \> 28 kg.m-2
  • Smoker
  • Alcool intake \> 10g/day
  • Psychiatric diseases
  • Subjects under treatment able to interfere with their cardiovascular, metabolic and neurological status

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Grenoble University Hospital

Grenoble, Auvergne-RhĂ´ne-Alpes, 38043, France

Location

Related Publications (37)

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  • LE Roux-Mallouf T, Vallejo A, Pelen F, Halimaoui I, Doutreleau S, Verges S. Synergetic Effect of NO Precursor Supplementation and Exercise Training. Med Sci Sports Exerc. 2020 Nov;52(11):2437-2447. doi: 10.1249/MSS.0000000000002387.

MeSH Terms

Interventions

NitratesArginineCitrulline

Intervention Hierarchy (Ancestors)

AnionsIonsElectrolytesInorganic ChemicalsNitric AcidNitrogen CompoundsOrganic ChemicalsAmino Acids, BasicAmino AcidsAmino Acids, Peptides, and ProteinsAmino Acids, DiaminoAmino Acids, Essential

Study Officials

  • StĂ©phane Doutreleau, PhD

    University Hospital, Grenoble

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 18, 2016

First Posted

August 1, 2016

Study Start

May 9, 2016

Primary Completion

September 1, 2021

Study Completion

September 1, 2021

Last Updated

December 29, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations