Effect of Different Foods Together With a Small Dose of Alcohol on Alcohol Levels in Healthy Subjects
Condition: Alcohol Use, Unspecified
MeSH terms: Alcohol Drinking
Study type: Interventional

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.
    

Detailed description: 
      Alcohol consumption is not a new phenomenon; it has been part of human culture since the
      start of recorded time. As a consequence, advice on alcohol consumption is also not new with
      probably the best-known one by the Greek playwright Eubulus:

      "Three bowls do I mix for the temperate: one to health, which they empty first; the second to
      love and pleasure; the third to sleep. When this bowl is drunk up, wise guests go home. The
      fourth bowl is ours no longer, but belongs to violence; the fifth to uproar; the sixth to
      drunken revel; the seventh to black eyes; the eighth is the policeman's; the ninth belongs to
      biliousness, and the tenth to madness and the hurling of furniture".

      Moderate alcohol consumption appears to provide some protection against certain illnesses,
      including heart disease and diabetes, however counterbalancing this is that, simultaneously,
      alcohol consumption will also increase the risk of other serious diseases (Bagnardi et al,
      2004; Di Castelnouvo et al, 2006; Djousse and Gaziano, 2008; Rehm et al, 2006; Standridge et
      al, 2004) as well as injury (Taylor et al, 2010). As the amount of alcohol usually consumed
      in a day increases, so does the risk of a wide range of physical and mental illnesses,
      including a number of cancers, liver disease and depression (Rehm et al, 2006).

      As a consequence, the current advice as given by the USDA is not to consume alcohol at all
      and, when alcohol is consumed, it is to be done in moderation within a healthy eating
      pattern. These recommendations are consistent with the most recent review of global alcohol
      usage and the risks it poses (GBD 2016 Alcohol Collaborators, 2018).

      Despite these guidelines, 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 (www.niaaa.nih.gov/alcohol-health).

      A person's maximal BAC, under a particular drinking scenario, is a result of many factors
      including how much alcohol they consumed, how quickly they consumed it, and the amount and
      characteristics of the food in their stomach. The contents of the stomach play a critical
      role in determining the alcohol absorption rate, and the maximal BAC, through their effect on
      the rate of gastric emptying (Holt, 1981). Furthermore, slower gastric emptying has been
      shown to increase the first pass metabolism of alcohol, both in the stomach as well as the
      liver, and can further diminish peak BAC (Oneta et al, 1998). Therefore, a food which has the
      ability to significantly slow the gastric emptying rate would be expected to significantly
      delay alcohol absorption, and due to increased first pass inactivation, limit the peak BAC as
      compared to drinking on an empty stomach. SOBAR is a high protein nutrition bar optimized to
      delay gastric emptying which has shown significant efficacy and safety in pilot studies.

      Zeno Functional Foods ("ZENO") is an emerging company formed in January 2017 and
      headquartered in Redwood City, CA. ZENO's focus is on the development of functional foods for
      the improvement of public health. Their first product is a protein bar, SOBAR, developed 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. In
      preliminary case studies, test subjects were given a defined cocktail after consuming either
      no food, a SOBAR prototype, a similarly caloric control food or a full meal, and the value of
      alcohol in the blood (BAC) was calculated from breath samples by a calibrated breathalyzer.
      BAC was lower after the SOBAR compared to having no food or comparable foods and were similar
      when compared to BAC levels after a full meal.

      As the preliminary results were encouraging, a full clinical study using a similar paradigm
      to the case studies is now planned to explore the effect of SOBAR on BAC levels. The study
      will utilize an open-label, randomized controlled design and assess BAC indirectly from
      breath measurements using a calibrated breathalyzer. A calibrated breathalyzer is the
      standard method for an indirect measure of blood alcohol concentration and is well
      established to provide a reliable estimate of BAC, therefore, blood samples will not be
      collected.

      PRIMARY OBJECTIVE:

      To compare the maximal BAC concentration (BAC Cmax) estimated using a breathalyzer over 90
      minutes after ingestion of a 20% by volume alcoholic drink after ingestion of either a SOBAR,
      an isocaloric control food, a full meal, or no food.

      SECONDARY OBJECTIVES:

      To compare the alcohol pharmacokinetics over 90 minutes (as measured by the IAUC60 and 90min)
      after ingestion of either a SOBAR, an isocaloric control food, a full meal, or when no food
      is consumed.

      To compare the time to reach the maximal (BAC Tmax) using a breathalyzer after ingestion of
      either a SOBAR, an isocaloric control food, a full meal, or when no food is consumed.
    

Intervention name(s): SOBAR; Control food; Full meal
Intervention type(s): Other; Other; Other
Intervention description(s): SOBAR is a high protein nutrition bar optimized to delay gastric emptying; Chexmix (General Mills Inc.), Honey Nut Flavor; Stouffer's Bistro Crostini 5 cheeses, Oikos Strawberry yogurt, Tropicana Orange juice, Dad's oatmeal cookie
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Open label, randomized, crossover, controlled study
Masking: None (Open Label)
Primary purpose: Prevention