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CompletedNCT02141880Updated Nov 2, 2020

The Tailgate Study: A Pilot Study Measuring the Impact of Acute Alcohol Intake on Intrahepatic Lipid

An observational study in Obesity, sponsored by University of Missouri-Columbia. Completed at 1 site in United States. Open to male participants aged 21 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-11-02.

Sponsored by University of Missouri-Columbia · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
25
Ages
21 Years to 40 Years
Sex
Male
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Study summary

College drinking associated with sporting events is characterized by excess alcohol, along with food intake, over the duration of hours has the potential to cause a build up of fat in the liver. Fatty liver can increase blood glucose concentrations leading to a prediabetes like state.

The present study will determine how overweight men respond to the over-consumption of alcohol/food to identify which characteristics might protect some men from fatty liver, while others might be more susceptible to this condition.

The goal of this work is to determine the direct impact of alcohol/food intake to cause acute fatty liver through the stimulation of de novo lipogenesis in 20 overweight, healthy men. Understanding individual susceptibility to alcohol-induced fatty liver will aid in the development of strategies designed to help people mitigate these risks.

Hypothesis is that 5h excess consumption of alcohol and food will increase liver triglycerides by 4% or more, in comparison to fasting state.

Read the detailed description

Subjects will participate in a single screening visit and a 24 hours in-patient stay at the clinical research center for treatment and tests.

No drugs will be used in this study, however, amounts of alcohol will be consumed to achieve, and maintain a breath alcohol at the legal limit (0.10).

The goals are to quantitate the increase in lipogenesis due to acute alcohol/food intake and to determine the effects of acute alcohol/food intake on liver-triglycerides.

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Conditions studied

  • Obesity

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Keywords

  • Obesity
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In context

Alcohol Drinking

925 studies on the registry are indexed under Alcohol Drinking; 172 are open to participants now.

This study's enrollment of 25 is below the median of 227 across 90 observational studies indexed under Alcohol Drinking.

Browse Alcohol Drinking studies →

Lead sponsor

University of Missouri-Columbia is the lead sponsor of 357 studies on the registry; 70 are open to participants now.

Of its 42 completed or terminated interventional studies of FDA-regulated products, 28 (67%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
21 Years to 40 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Healthy and overweight sedentary men.

Inclusion criteria

  • Men
  • Age 21-40
  • BMI 25.1-35.0 kg/m2
  • Waste girth \< 55 inches
  • Nonsmoking
  • Moderate consumer of alcohol
  • Fasting blood glucose \< 125 mg/dL, alanine transaminase activity \< 40 milliunits/L, plasma triglycerides \< 200 mg/dL
  • Sedentary
  • Free of metabolic disorders

Exclusion criteria

Exclusion Criteria:

  • BMI \< 25.1 or > 35.0 kg/m2
  • Waste girth of greater 55 inches
  • Use of any tabacco product
  • Fasting plasma glucose ≥125 mg/dL, alanine transaminase activity ≥ 40 milliunits/L, plasma triglycerides ≥125 mg/dL
  • Physically active
  • Diabetes or other diseases that impact blood glucose or lipids
  • Fatty liver disease
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
25 participants (actual)
Patient registry
No

Groups and cohorts

  • Treatment

    All subjects will be under the same protocol which is eating and drinking on one afternoon.

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What researchers measure

Primary outcomes

  1. Liver triglycerides

    Liver fat will be measured twice in each subject via magnetic resonance spectroscopy, blood will be drawn hourly and metabolites will be measured enzymatically.

    Time frame: will be measured before (fasting) and after 5 hours of alcohol consumption

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Study locations

1 site
  • University of Missouri
    Columbia, Missouri 65212, United States
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 2, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02141880
Lead sponsor
University of Missouri-Columbia
Responsible party
Elizabeth Parks (Professor, Nutrition & Exercise Physiology-MED, University of Missouri-Columbia) — Principal investigator
First posted
May 20, 2014
Start date
Jun 2014
Primary completion
Jan 2019
Completion
Jan 2020
Last update
Nov 2, 2020

Study contacts

Elizabeth J Parks, PhD
principal investigator · University of Missouri-Columbia

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2020. You cannot join it, but the record below documents what was studied.

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