Ignite Creation Date:
2025-12-26 @ 10:20 PM
Ignite Modification Date:
2025-12-26 @ 10:20 PM
Study NCT ID:
NCT03867812
Status:
COMPLETED
Last Update Posted:
2019-11-29
First Post:
2019-03-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Different Foods Together With a Small Dose of Alcohol on Alcohol Levels in Healthy Subjects
Sponsor:
Zeno Functional Foods, LLC
Organization:
Study Overview
Official Title:
Effect of Consumption of Different Foods on the Pharmacokinetics of a Small Dose of Ethanol: A Randomized Controlled, Clinical Trial in Healthy Individuals
Status:
COMPLETED
Status Verified Date:
2019-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
"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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: