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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02141880
• Other study ID #: 1211233
• Status: Completed
• Start date: June 2014
• Est. completion date: January 2020

Study information

• Verified date: October 2020
• Source: University of Missouri-Columbia
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: January 2020
• Est. primary completion date: January 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 21 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Alcohol Drinking
• Obesity

Locations

Country	Name	City	State
United States	University of Missouri	Columbia	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
University of Missouri-Columbia

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	will be measured before (fasting) and after 5 hours of alcohol consumption