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NCT Number: NCT04829110

Alcohol Induced de Novo Lipogenesis in Women

The study is cross-sectional is design. In the first Aim of this study, 5 women and 5 men will be asked to consume 2g/kg of [2H]water (a.k.a. deuterium oxide or heavy water) which incorporates 2H tracers into newly synthesized fatty acids and triglycerides. Deuterated water is not radioactive and has a long history of application in human studies. Researchers will collect blood samples 2 hours before and 5 hours after the participants consume 20 grams of alcohol as vodka to measure alcohol induced hepatic de novo lipogenesis (DNL) in both men in women. In addition, for Aim 2 researchers will recruit an additional 10 women who will be randomized into one of two groups who will consume a beverage containing vodka and sucrose, or sucrose alone. Aim 2 will be identical to the experimental scheme in Aim 2 in order to determine if sucrose enhances the effects of vodka on hepatic DNL.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Liver Metabolism

Age range

21 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

School of Health Professions at UTSW

Dallas, Texas, 75390, United States

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Male or Female
  • Ages 21 - 45
  • Healthy
  • Light to moderate alcohol consumption (≤1 drink a day (~14g) in women and ≤2 drinks a day (~28 g) in men)
  • BMI between 18.5-29.9
  • Normal Nutritional Status
  • Ability to speak and understand English

Exclusion criteria

  • BMI >29.9
  • Comorbid conditions
  • Any regular medications, except Oral Contraceptives
  • Pregnant or Breastfeeding
  • Regular exercise above activities of daily living

Treatment and study plan

ETOH

Other

Participants will consume Vodka

Other names: Vodka

Sucrose

Other

Participants will consume sucrose in solution with water

Other names: Sucrose solution

Primary outcomes

  1. Mean Change in Hepatic De Novo Lipogenesis (DNL)

    Time frame: 0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, and 7 hours post heavy water consumption

    DNL will be measured by Orbitrap high-resolution-mass-spectrometry (GC-Orbitrap-HRMS)

    We will measure changes in the incorporation of 2H tracers into plasma triglycerides over time. This data will be analyzed by averaging each time point and looking at change in de novo lipogenesis over time.

Sponsors and collaborators

Lead sponsor

University of Texas Southwestern Medical Center

Other

Registry information

Important dates

Study start
2021
Primary completion
2027
Study completion
2027
First posted
Apr 2, 2021
Registry last updated
May 7, 2026

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.

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