Alcohol Induced de Novo Lipogenesis in Women

The University of Texas System (UT)

Status: Active, not recruiting

Conditions: Liver Metabolism

Treatments: Other: ETOH; Other: Sucrose

Study type: Interventional

Funder types: Other

Identifiers

NCT04829110

STU-2021-0246

Details and patient eligibility

About

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.

Enrollment: 27 patients

Sex: All

Ages: 21 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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27 participants in 3 patient groups

A. ETOH

Experimental group

Description:

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.

Treatment:

Other: ETOH

ETOH + Sucrose

Experimental group

Description:

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.

Treatment:

Other: Sucrose

Other: ETOH

C. Sucrose

Experimental group

Description:

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.

Treatment:

Other: Sucrose