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

NCT ID: NCT02141880

Last Updated: 2020-11-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

25 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-06-30

Study Completion Date

2020-01-31

Brief Summary

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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

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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.

Conditions

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Obesity

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Treatment

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

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Maximum Eligible Age

40 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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University of Missouri-Columbia

OTHER

Sponsor Role lead

Responsible Party

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Elizabeth Parks

Professor, Nutrition & Exercise Physiology-MED

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Elizabeth J Parks, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Missouri-Columbia

Locations

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University of Missouri

Columbia, Missouri, United States

Site Status

Countries

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United States

Other Identifiers

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1211233

Identifier Type: -

Identifier Source: org_study_id