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

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.

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Key information

Conditions

Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

21 year–40 year

Sex eligibility

Male

Study type

Observational

Primary location

University of Missouri

Columbia, Missouri, 65212, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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.

Sponsors and collaborators

Lead sponsor

University of Missouri-Columbia

Other

Registry information

Important dates

Study start: 2014
Primary completion: 2019
Study completion: 2020
First posted: May 20, 2014
Registry last updated: Nov 2, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed