Alcohol Induced de Novo Lipogenesis in Women

Not Applicable

Active, not recruiting

• Conditions: Liver Metabolism
• Interventions: Other: ETOH; Other: Sucrose

• Registration Number: NCT04829110
• Lead Sponsor: University of Texas Southwestern Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-03-18
• Study First Submitted QC: 2021-03-30
• Study First Posted: 2021-04-02
• Study Start: 2021-11-11
• Status Verified: 2025-03
• Last Update Submitted: 2025-04-01
• Last Update Posted: 2025-04-04
• Primary Completion: 2026-03-31
• Study Completion: 2026-03-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 27

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ETOH + Sucrose	Sucrose	5 Females will receive deuterated water and drink 1.72 ounces of alcohol in the form of vodka + 7 grams of sucrose and have de novo Lipogenesis measured at 11 time points during and after.
A. ETOH	ETOH	5 Males and 5 Females will receive deuterated water and drink 2.15 ounces of alcohol in the form of vodka and have de novo Lipogenesis measured at 11 time points during and after.
ETOH + Sucrose	ETOH	5 Females will receive deuterated water and drink 1.72 ounces of alcohol in the form of vodka + 7 grams of sucrose and have de novo Lipogenesis measured at 11 time points during and after.
C. Sucrose	Sucrose	5 Females will receive deuterated water and drink a solution containing water and 35 grams of sucrose, and have de novo Lipogenesis measured at 11 time points during and after.

Primary Outcome Measures

Name	Time	Method
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 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.

Trial Locations

Locations (1)

School of Health Professions at UTSW; 🇺🇸 Dallas, Texas, United States