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Alcohol Induced de Novo Lipogenesis in Women

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ClinicalTrials.gov Identifier: NCT04829110
Recruitment Status : Recruiting
First Posted : April 2, 2021
Last Update Posted : December 1, 2021
Sponsor:
Information provided by (Responsible Party):
Justin Fletcher, 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.

Condition or disease Intervention/treatment Phase
Liver Metabolism Other: ETOH Other: Sucrose Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Alcohol Induced de Novo Lipogenesis in Women
Actual Study Start Date : November 11, 2021
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine

Drug Information available for: Sucrose

Arm Intervention/treatment
Experimental: 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.
Other: ETOH
Participants will consume Vodka
Other Name: Vodka

Experimental: 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.
Other: ETOH
Participants will consume Vodka
Other Name: Vodka

Other: Sucrose
Participants will consume sucrose in solution with water
Other Name: Sucrose solution

Experimental: 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.
Other: Sucrose
Participants will consume sucrose in solution with water
Other Name: Sucrose solution




Primary Outcome Measures :
  1. Mean Change in Hepatic De Novo Lipogenesis (DNL) [ Time Frame: 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.




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Ages Eligible for Study:   21 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04829110


Contacts
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Contact: Justin Fletcher, PhD 913-314-4274 justin.fletcher@utsouthwestern.edu
Contact: Lucy H Christie, BSN, RN 214-648-3394 lucy.christie@utsouthwestern.edu

Locations
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United States, Texas
School of Health Professions at UTSW Recruiting
Dallas, Texas, United States, 75390
Contact: Justin Fletcher, PhD    214-648-7879    justin.fletcher@utsouthwestern.edu   
Contact: Lucy Christie, BSN, RN    214-648-3394    lucy.christie@utsouthwestern.edu   
Sponsors and Collaborators
University of Texas Southwestern Medical Center
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Responsible Party: Justin Fletcher, Assistant Professor, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT04829110    
Other Study ID Numbers: STU-2021-0246
First Posted: April 2, 2021    Key Record Dates
Last Update Posted: December 1, 2021
Last Verified: November 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No