Alcohol Induced de Novo Lipogenesis in Women

Liver Metabolism Clinical Trial

Official title:

Alcohol Induced de Novo Lipogenesis in Women

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04829110
• Other study ID #: STU-2021-0246
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 11, 2021
• Est. completion date: December 31, 2025

Study information

• Verified date: March 2024
• Source: University of Texas Southwestern Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 20
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Liver Metabolism

Intervention

Other:
• ETOH
Participants will consume Vodka
• Sucrose
Participants will consume sucrose in solution with water

Locations

Country	Name	City	State
United States	School of Health Professions at UTSW	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
University of Texas Southwestern Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Change in Hepatic De Novo Lipogenesis (DNL)	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.	0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, and 7 hours post heavy water consumption