Clinical trial NCT02141880: The Tailgate Study: A Pilot Study Measuring the Impact of Acute Alcohol Intake on Intrahepatic Lipid
Official title: The Tailgate Study: A Pilot Study Measuring the Impact of Acute Alcohol Intake on Intrahepatic Lipid
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obesity
Keywords: Obesity
Lead sponsor: University of Missouri-Columbia
Sponsor class: OTHER
First posted: 2014-05-20
Enrollment: 25
Sex: MALE
Minimum age (years): 21
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy and overweight sedentary men.

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.

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.

Eligibility 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

Primary outcomes:
measure: Liver triglycerides
timeFrame: will be measured before (fasting) and after 5 hours of alcohol consumption
Secondary outcomes:
Other outcomes:
Locations:
city: Columbia
country: United States
facility: University of Missouri
state: Missouri
Study officials:
affiliation: University of Missouri-Columbia
name: Elizabeth J Parks, PhD
role: PRINCIPAL_INVESTIGATOR
References: