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

NCT03867812 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2019-11-29

No results posted yet for this study

Summary

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.

Conditions

  • Alcohol Use, Unspecified

Interventions

OTHER

SOBAR

SOBAR is a high protein nutrition bar optimized to delay gastric emptying

OTHER

Control food

Chexmix (General Mills Inc.), Honey Nut Flavor

OTHER

Full meal

Stouffer's Bistro Crostini 5 cheeses, Oikos Strawberry yogurt, Tropicana Orange juice, Dad's oatmeal cookie

Sponsors & Collaborators

  • INQUIS Clinical Research

    collaborator INDUSTRY

  • Zeno Functional Foods, LLC

    lead INDUSTRY

Principal Investigators

  • Thomas Wolever, D.M., Ph.D. · INQUIS Clinical Research

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
25 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-03-08
Primary Completion
2019-07-15
Completion
2019-07-30

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03867812 on ClinicalTrials.gov