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

NCT02141880 | Completed

• 1 other identifier: 1211233
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity

Keywords

Obesity

Outcome Measures

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.

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

Study Arms (1)

Treatment

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

Eligibility Criteria

• Age: 21 Years - 40 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Healthy and overweight sedentary men.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Missouri-Columbia: lead

Study Sites (1)

University of Missouri

Columbia, Missouri, 65212, United States

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

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

Study Officials

• Elizabeth J Parks, PhD

  University of Missouri-Columbia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Nutrition & Exercise Physiology-MED

Study Record Dates

• First Submitted: May 14, 2014
• First Posted: May 20, 2014
• Study Start: June 1, 2014
• Primary Completion: January 1, 2019
• Study Completion: January 1, 2020
• Last Updated: November 2, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)