Alcohol Induced de Novo Lipogenesis in Women

NCT ID: NCT04829110

Last Updated: 2025-04-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

27 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-11

Study Completion Date

2026-03-31

Brief Summary

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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

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Conditions

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Liver Metabolism

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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A. 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.

Group Type EXPERIMENTAL

ETOH

Intervention Type OTHER

Participants will consume Vodka

ETOH + 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.

Group Type EXPERIMENTAL

ETOH

Intervention Type OTHER

Participants will consume Vodka

Sucrose

Intervention Type OTHER

Participants will consume sucrose in solution with water

C. 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.

Group Type EXPERIMENTAL

Sucrose

Intervention Type OTHER

Participants will consume sucrose in solution with water

Interventions

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ETOH

Participants will consume Vodka

Intervention Type OTHER

Sucrose

Participants will consume sucrose in solution with water

Intervention Type OTHER

Other Intervention Names

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Vodka Sucrose solution

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Texas Southwestern Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Justin Fletcher

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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School of Health Professions at UTSW

Dallas, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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STU-2021-0246

Identifier Type: -

Identifier Source: org_study_id

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