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Alcohol Induced de Novo Lipogenesis in Women

Alcohol Induced de Novo Lipogenesis in Women

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04829110
Enrollment
27
Registered
2021-04-02
Start date
2021-11-11
Completion date
2027-03-31
Last updated
2026-05-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Liver Metabolism

Brief summary

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.

Interventions

OTHERETOH

Participants will consume Vodka

OTHERSucrose

Participants will consume sucrose in solution with water

Sponsors

University of Texas Southwestern Medical Center
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
21 Years to 45 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Mean Change in Hepatic De Novo Lipogenesis (DNL)0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, and 7 hours post heavy water consumptionDNL 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 8, 2026