Alcohol Induced de Novo Lipogenesis in Women

NCT04829110 | Active Not Recruiting

• 1 other identifier: STU-2021-0246
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

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.

Conditions

Liver Metabolism

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

A. ETOH

EXPERIMENTAL

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.

Other: ETOH

ETOH + Sucrose

EXPERIMENTAL

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.

Other: ETOH; Other: Sucrose

C. Sucrose

EXPERIMENTAL

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.

Other: Sucrose

Interventions

ETOH OTHER

Participants will consume Vodka

Also known as: Vodka

A. ETOH; ETOH + Sucrose

Sucrose OTHER

Participants will consume sucrose in solution with water

Also known as: Sucrose solution

C. Sucrose; ETOH + Sucrose

Eligibility Criteria

• Age: 21 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead

Study Sites (1)

School of Health Professions at UTSW

Dallas, Texas, 75390, United States

Location

MeSH Terms

Interventions

Sucrose; sodium lactobionate sucrose solution

Intervention Hierarchy (Ancestors)

Disaccharides; Oligosaccharides; Polysaccharides; Carbohydrates; Sugars

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: March 18, 2021
• First Posted: April 2, 2021
• Study Start: November 11, 2021
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): March 31, 2027
• Last Updated: May 7, 2026

Record last verified: 2026-04

Locations

US (1)