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

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ClinicalTrials.gov Identifier: NCT02141880
Recruitment Status : Completed
First Posted : May 20, 2014
Last Update Posted : November 2, 2020
Sponsor:
Information provided by (Responsible Party):
Elizabeth Parks, University of Missouri-Columbia

Study Description
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Brief 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.


Condition or disease
Obesity

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.

Study Design
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Study Type : Observational
Actual Enrollment : 25 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Tailgate Study: A Pilot Study Measuring the Impact of Acute Alcohol Intake on Intrahepatic Lipid
Actual Study Start Date : June 2014
Actual Primary Completion Date : January 2019
Actual Study Completion Date : January 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Alcohol

Groups and Cohorts
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Group/Cohort
Treatment
All subjects will be under the same protocol which is eating and drinking on one afternoon.


Outcome Measures
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Primary Outcome Measures :
  1. Liver triglycerides [ Time Frame: will be measured before (fasting) and after 5 hours of alcohol consumption ]
    Liver fat will be measured twice in each subject via magnetic resonance spectroscopy, blood will be drawn hourly and metabolites will be measured enzymatically.


Eligibility Criteria
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Ages Eligible for Study:   21 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Healthy and overweight sedentary men.
Criteria

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:

  • 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
Contacts and Locations
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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): NCT02141880


Locations
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United States, Missouri
University of Missouri
Columbia, Missouri, United States, 65212
Sponsors and Collaborators
University of Missouri-Columbia
Investigators
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Principal Investigator: Elizabeth J Parks, PhD University of Missouri-Columbia
More Information
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Responsible Party: Elizabeth Parks, Professor, Nutrition & Exercise Physiology-MED, University of Missouri-Columbia
ClinicalTrials.gov Identifier: NCT02141880    
Other Study ID Numbers: 1211233
First Posted: May 20, 2014    Key Record Dates
Last Update Posted: November 2, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Elizabeth Parks, University of Missouri-Columbia:
Obesity
Additional relevant MeSH terms:
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Alcohol Drinking
Drinking Behavior