Actively Recruiting

Early Phase 1
Age: 21Years - 65Years
All Genders
Healthy Volunteers
NCT05025865

HA35 Acute Alcohol Study

Led by The Cleveland Clinic · Updated on 2025-11-17

24

Participants Needed

1

Research Sites

295 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Eligible subjects will be asked to take a placebo/treatment capsule for a total of 3 days and then participate in a study visit on the fourth day. This study visit will include a medical exam, clinical labs, questionnaires, body composition measurements, and urine and stool collections. Additionally, participants will consume a sugar cocktail to measure their gut permeability, participate in an acute ethanol challenge, and undergo two muscle biopsies. The study will take approximately 3-4 hours and a designated driver will need to drive the participant home. On the fifth day, you will be asked to return to drop of the 24-hour urine collection.

CONDITIONS

Official Title

HA35 Acute Alcohol Study

Who Can Participate

Age: 21Years - 65Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Alcohol consumption of less than 7 drinks per week for women and less than 14 drinks per week for men
  • Ability to understand and willingness to provide written consent
Not Eligible

You will not qualify if you...

  • Any known chronic illness including but not limited to cancer (except non-melanoma skin cancer)
  • Poorly controlled diabetes (Hemoglobin A1c >9.5 g/dl)
  • Untreated hyper/hypothyroidism
  • Uncontrolled hypertension or hypercholesterolemia
  • End-stage renal disease
  • Liver disease of any etiology
  • Coronary artery disease or stroke
  • Active intravenous drug use
  • History of gastric bypass
  • Medications known to alter muscle protein synthesis (systemic corticosteroids, tamoxifen, high dose estrogen, testosterone, or anabolic steroids)
  • Pregnancy
  • Past alcohol use disorder
  • Abnormal clotting factors

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Cleveland Clinic

Cleveland, Ohio, United States, 44195

Actively Recruiting

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Research Team

S

Srinivasan Dasarathy, MD

CONTACT

A

Annette Bellar

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

BASIC_SCIENCE

Number of Arms

2

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HA35 Acute Alcohol Study | DecenTrialz