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NCT03867812

Effect of Different Foods Together With a Small Dose of Alcohol on Alcohol Levels in Healthy Subjects

Completed NA Last updated 29 November 2019
What this trial tests

NA trial testing SOBAR in Alcohol Use, Unspecified in 21 participants. Completed in 30 July 2019.

Timeline
8 March 2019
Primary endpoint
15 July 2019
30 July 2019

Quick facts

Lead sponsorZeno Functional Foods, LLC
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designcrossover
Maskingnone
Primary purposeprevention
Enrollment21
Start date8 March 2019
Primary completion15 July 2019
Estimated completion30 July 2019
Sites1 location across Canada

Drugs / interventions tested

Conditions studied

Sponsor

Zeno Functional Foods, LLC

Who can join

Adults 25 to 65, any sex, with Alcohol Use, Unspecified. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Alcohol consumption is prevalent and frequently excessive and its use poses a major risk to both personal and public health. In the U.S., every month over 25% of adults and 40% of college students drink until their blood alcohol concentration (BAC) exceeds the legal limit of 0.08% and there is a great unmet need for interventions to help individuals better manage their BACs. Zeno Functional Foods has developed a protein bar, SOBAR, with the aim to control alcohol absorption when eaten prior to drinking. It is hypothesized that the SOBAR will slow stomach emptying resulting in a comparatively diminished peak BAC as well as a more stable BAC-time profile that is both safer and more pleasurable for the drinker.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Effect of a Snack Bar Optimized to Reduce Alcohol Bioavailability: A Randomized Controlled Clinical Trial in Healthy Individuals.
    Fisher JM, Wolever TMS, Campbell JE, Ezatagha A, et al · · 2020 · cited 2× · PMID 31755823 · DOI 10.1089/jmf.2019.0228

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Other recruiting trials for Alcohol Use, Unspecified

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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/NCT03867812.

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