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

NCT03867812 | Completed

• 1 other identifier: GIL-1842
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

Alcohol Use, Unspecified

Outcome Measures

Primary Outcomes (1)

• Maximal blood alcohol concentration (BAC Cmax)

  As measured indirectly using a breathalyzer, the level of peak BAC during the experimental timeframe.

  90 minutes

Secondary Outcomes (3)

• Incremental area under the curve at 60min (IAUC 60)

  60 minutes

• Incremental area under the curve at 90min (IAUC 90)

  90 minutes

• Time to reach maximal blood alcohol concentration (BAC Tmax)

  90 minutes

Study Arms (4)

Fasting + alcoholic drink

NO INTERVENTION

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).

SOBAR bar + alcoholic drink

EXPERIMENTAL

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

Control food + alcoholic drink

ACTIVE COMPARATOR

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

Full meal + alcoholic drink

ACTIVE COMPARATOR

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

Interventions

SOBAR OTHER

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

SOBAR bar + alcoholic drink

Control food OTHER

Chexmix (General Mills Inc.), Honey Nut Flavor

Control food + alcoholic drink

Full meal OTHER

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

Full meal + alcoholic drink

Eligibility Criteria

• Age: 25 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zeno Functional Foods, LLC: lead
• INQUIS Clinical Research: collaborator

Study Sites (1)

INQUIS Clinical Research Ltd.

Toronto, Ontario, M5C 2N8, Canada

Location

Related Publications (9)

• Di Castelnuovo A, Costanzo S, Bagnardi V, Donati MB, Iacoviello L, de Gaetano G. Alcohol dosing and total mortality in men and women: an updated meta-analysis of 34 prospective studies. Arch Intern Med. 2006 Dec 11-25;166(22):2437-45. doi: 10.1001/archinte.166.22.2437.

  PMID: 17159008 BACKGROUND

• Djousse L, Gaziano JM. Alcohol consumption and heart failure: a systematic review. Curr Atheroscler Rep. 2008 Apr;10(2):117-20. doi: 10.1007/s11883-008-0017-z.

  PMID: 18417065 BACKGROUND

• Bagnardi V, Zambon A, Quatto P, Corrao G. Flexible meta-regression functions for modeling aggregate dose-response data, with an application to alcohol and mortality. Am J Epidemiol. 2004 Jun 1;159(11):1077-86. doi: 10.1093/aje/kwh142.

  PMID: 15155292 BACKGROUND

• 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.

  BACKGROUND

• Standridge JB, Zylstra RG, Adams SM. Alcohol consumption: an overview of benefits and risks. South Med J. 2004 Jul;97(7):664-72. doi: 10.1097/00007611-200407000-00012.

  PMID: 15301124 BACKGROUND

• Taylor B, Irving HM, Kanteres F, Room R, Borges G, Cherpitel C, Greenfield T, Rehm J. The more you drink, the harder you fall: a systematic review and meta-analysis of how acute alcohol consumption and injury or collision risk increase together. Drug Alcohol Depend. 2010 Jul 1;110(1-2):108-16. doi: 10.1016/j.drugalcdep.2010.02.011. Epub 2010 Mar 16.

  PMID: 20236774 BACKGROUND

• GBD 2016 Alcohol and Drug Use Collaborators. The global burden of disease attributable to alcohol and drug use in 195 countries and territories, 1990-2016: a systematic analysis for the Global Burden of Disease Study 2016. Lancet Psychiatry. 2018 Dec;5(12):987-1012. doi: 10.1016/S2215-0366(18)30337-7. Epub 2018 Nov 1.

  PMID: 30392731 BACKGROUND

• Holt S. Observations on the relation between alcohol absorption and the rate of gastric emptying. Can Med Assoc J. 1981 Feb 1;124(3):267-77, 297.

  PMID: 7459787 BACKGROUND

• Oneta CM, Simanowski UA, Martinez M, Allali-Hassani A, Pares X, Homann N, Conradt C, Waldherr R, Fiehn W, Coutelle C, Seitz HK. First pass metabolism of ethanol is strikingly influenced by the speed of gastric emptying. Gut. 1998 Nov;43(5):612-9. doi: 10.1136/gut.43.5.612.

  PMID: 9824340 BACKGROUND

MeSH Terms

Conditions

Alcohol Drinking

Interventions

Hazard Analysis and Critical Control Points

Condition Hierarchy (Ancestors)

Drinking Behavior; Behavior

Intervention Hierarchy (Ancestors)

Food Safety; Food Quality; Food Technology; Food Industry; Industry; Technology, Industry, and Agriculture; Safety; Accident Prevention; Accidents; Public Health; Environment and Public Health

Study Officials

• Thomas Wolever, D.M., Ph.D.

  INQUIS Clinical Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Open label, randomized, crossover, controlled study

Study Record Dates

• First Submitted: March 5, 2019
• First Posted: March 8, 2019
• Study Start: March 8, 2019
• Primary Completion: July 15, 2019
• Study Completion: July 30, 2019
• Last Updated: November 29, 2019

Record last verified: 2019-11

Locations

CA (1)