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NCT04700241: NO-BRAINS

Nitrate and Brain Insulin-Sensitivity

Completed NA Last updated 9 June 2021
What this trial tests

NA trial testing Potassium nitrate in Nitrate in 18 participants. Completed in 5 May 2021.

Timeline
21 January 2021
Primary endpoint
5 May 2021
5 May 2021

Quick facts

Lead sponsorMaastricht University Medical Center
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designcrossover
Maskingtriple
Primary purposeprevention
Enrollment18
Start date21 January 2021
Primary completion5 May 2021
Estimated completion5 May 2021
Sites1 location across Netherlands

Drugs / interventions tested

Conditions studied

Sponsor

Maastricht University Medical Center

Who can join

Adults 18 to 60, male only, with Nitrate or Brain Insulin-sensitivity. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Disturbances in brain insulin-sensitivity are not only observed in abdominal obesity and type 2 diabetes mellitus (T2D), but also during brain aging and in dementia. Inorganic nitrate may improve brain insulin-sensitivity, which can be quantified by measuring the gray-matter cerebral blood flow (CBF) response to intranasally administered insulin, through beneficial effects on brain vascular function. Therefore, we now hypothesize that inorganic nitrate, which can be found in several vegetables such as beetroot, improves brain insulin-sensitivity, as assessed by the gray-matter CBF response to intranasally administered insulin, in abdominally obese men.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Acute inorganic nitrate intake increases regional insulin action in the brain: Results of a double-blind, randomized, controlled cross-over trial with abdominally obese men.
    Kleinloog JPD, Mensink RP, Smeets ETHC, Ivanov D, et al · · 2022 · cited 5× · PMID 35843050 · DOI 10.1016/j.nicl.2022.103115
  2. Acute Effects of Inorganic Nitrate Intake on Brachial and Femoral Flow-Mediated Vasodilation, and on Carotid Artery Reactivity Responses: Results of a Randomized, Double-Blinded, Placebo-Controlled Cross-Over Study in Abdominally Obese Men.
    Smeets ETHC, Mensink RP, Kleinloog JPD, Joris PJ. · · 2022 · cited 4× · PMID 36079817 · DOI 10.3390/nu14173560

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Other trials of Potassium nitrate

Trials testing the same drug.

Other Maastricht University Medical Center trials

Trials by the same sponsor.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04700241.

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