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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03867812
Recruitment Status : Completed
First Posted : March 8, 2019
Last Update Posted : November 29, 2019
Sponsor:
Collaborator:
INQUIS Clinical Research Ltd.
Information provided by (Responsible Party):
Zeno Functional Foods, LLC

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.

Condition or disease Intervention/treatment Phase
Alcohol Use, Unspecified Other: SOBAR Other: Control food Other: Full meal Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Open label, randomized, crossover, controlled study
Masking: None (Open Label)
Primary Purpose: Prevention
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
Actual Study Start Date : March 8, 2019
Actual Primary Completion Date : July 15, 2019
Actual Study Completion Date : July 30, 2019

Arm Intervention/treatment
No Intervention: Fasting + alcoholic drink
No food (0 calories) but 250ml of water followed by an alcoholic drink (a 20% alcohol by volume cocktail dosed so that men receive 0.35g alcohol per kg of body weight and women a 0.30g/kg dose).
Experimental: SOBAR bar + alcoholic drink
One 70g bar (210 calories) plus 250ml of water followed by an alcoholic drink (a 20% alcohol by volume cocktail dosed so that men receive 0.35g alcohol per kg of body weight and women a 0.30g/kg dose).
Other: SOBAR
SOBAR is a high protein nutrition bar optimized to delay gastric emptying

Active Comparator: Control food + alcoholic drink
48.5g of General Mills Chexmix (Honey Nut Flavor, 210 calories) plus 250ml of water followed by an alcoholic drink (a 20% alcohol by volume cocktail dosed so that men receive 0.35g alcohol per kg of body weight and women a 0.30g/kg dose).
Other: Control food
Chexmix (General Mills Inc.), Honey Nut Flavor

Active Comparator: Full meal + alcoholic drink
Stouffer's Bistro Crostini 5 Cheeses, Oikos Strawberry yogurt, Tropicana Orange juice, Dad's oatmeal cookie (635 calories total) followed by an alcoholic drink (a 20% alcohol by volume cocktail dosed so that men receive 0.35g alcohol per kg of body weight and women a 0.30g/kg dose).
Other: Full meal
Stouffer's Bistro Crostini 5 cheeses, Oikos Strawberry yogurt, Tropicana Orange juice, Dad's oatmeal cookie




Primary Outcome Measures :
  1. Maximal blood alcohol concentration (BAC Cmax) [ Time Frame: 90 minutes ]
    As measured indirectly using a breathalyzer, the level of peak BAC during the experimental timeframe.


Secondary Outcome Measures :
  1. Incremental area under the curve at 60min (IAUC 60) [ Time Frame: 60 minutes ]
    As measured indirectly using a breathalyzer, the incremental area under the BAC vs time curve over the experimental timeframe.

  2. Incremental area under the curve at 90min (IAUC 90) [ Time Frame: 90 minutes ]
    As measured indirectly using a breathalyzer, the incremental area under the BAC vs time curve over the experimental timeframe.

  3. Time to reach maximal blood alcohol concentration (BAC Tmax) [ Time Frame: 90 minutes ]
    As measured indirectly using a breathalyzer, the time from the start of consuming the alcohol until the peak BAC is reached during the experimental timeframe.



Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Male or non-pregnant, non-lactating females, 25-65 years of age, inclusive
  • Body mass index 20 - 30 kg/m2 inclusive
  • Blood pressure: systolic < 140 and diastolic <95 mmHg.
  • Social drinkers; average 2 or fewer drinks per day and have not had an episode of "binge drinking" over the previous 30 days. Binge drinking is defined has having 4 or more drinks (for women) / 5 or more drinks (for men) over the course of 2 hours. One drink is defined as either 5oz wine, 341ml of beer/cider or 1.5 oz. of distilled 80-proof spirit.
  • Willing to maintain habitual diet, physical activity pattern, and body weight throughout the trial and consume the standard meal provided by GI Labs the evening before each test day
  • Subject is willing to abstain from strenuous exercise, alcoholic drinks, and cannabis use 24hours before study visits.
  • Subject is willing to refrain from driving or operating any vehicle when leaving GI Labs after the test visit
  • Subject is willing to sign on each test day a statement acknowledging that the subject is aware that he/she has consumed alcohol that morning
  • Willing to maintain current dietary supplement use throughout the trial. On test days, subject agrees not to take any dietary supplements or caffeine. Failure to comply will result in a rescheduled test visit.
  • No major illness or surgery requiring hospitalization within 3 months of the first study visit after screening.
  • No history of cardiovascular, metabolic, respiratory, renal, gastrointestinal or hepatic disease.
  • Subjects must be eligible to receive income in Canada and be covered by a health insurance such as OHIP.
  • Absence of health conditions that would prevent fulfillment of study requirements as judged by the Investigator on the basis of medical history.
  • Understanding the study procedures and willing to provide informed consent to participate in the study and authorization to release relevant protected health information to the study investigator.
  • Female subjects are willing to use a contraceptive method to avoid pregnancy during the study period. Willing to take a urine pregnancy test the day of each study.

Exclusion Criteria:

  • Failure to meet all the inclusion criteria
  • Smoker
  • Known history of gastrointestinal, liver, kidney, or cardiovascular (including but not limited to atherosclerotic disease, history of myocardial infarction, peripheral arterial disease, stroke), and pulmonary disease
  • History of mental disease, seizures, use or abuse of psychoactive medications (including but not limited to cocaine, amphetamines, opiates, sedatives, benzodiazepines, and hallucinogens) or any medication or condition which might, in the opinion of Dr. Wolever, the medical director of GI labs, either: 1) make participation dangerous to the subject or to others, or 2) affect the results.
  • Use of antibiotics within 4 weeks of start of study.
  • History or diagnosis of alcohol use disorder or binge drinking (4 or more drinks for women and 5 or more drinks for men within a 2-hour window) as defined by the current NIAAA guidelines.
  • Major trauma or surgical event within 3 months of screening.
  • Of East Asian descent or having a history of alcohol induced flushing reaction.
  • Unwillingness or inability to comply with the experimental procedures and to follow GI Labs safety guidelines.
  • Known intolerance, sensitivity or allergy to any ingredients in the study products.
  • Extreme dietary habits as judged by the Investigator (i.e. Atkins diet, very high protein diets, etc).
  • Change in body weight of >3.5kg within 4 weeks of the screening visit.
  • Presence of any signs or symptoms of an active infection within 5 d prior to any test visit. If an infection occurs during the study period, test visits should be rescheduled until all signs and symptoms have resolved and any treatment (i.e. antibiotic therapy) has been completed at least 5 d prior to each test visit.
  • History of cancer in the prior two years, except for non-melanoma skin cancer.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03867812


Locations
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Canada, Ontario
INQUIS Clinical Research Ltd.
Toronto, Ontario, Canada, M5C 2N8
Sponsors and Collaborators
Zeno Functional Foods, LLC
INQUIS Clinical Research Ltd.
Investigators
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Principal Investigator: Thomas Wolever, D.M., Ph.D. INQUIS Clinical Research Ltd.

Publications:
Rehm, J., Ballunas, D., Broschu, S., Fischer, B., Gnam, W. & Patras, J., et al. (2006a). The Costs of Substance Abuse in Canada, 2002. ISBN: 1-897321-10-4 (CD-ROM). Ottawa: Canadian Centre on Substance Abuse.

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Responsible Party: Zeno Functional Foods, LLC
ClinicalTrials.gov Identifier: NCT03867812    
Other Study ID Numbers: GIL-1842
First Posted: March 8, 2019    Key Record Dates
Last Update Posted: November 29, 2019
Last Verified: November 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Alcohol Drinking
Drinking Behavior
Ethanol
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs