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RECRUITING Early Phase 1 ClinicalTrials.gov

HA35 Acute Alcohol Study

Sponsor: The Cleveland Clinic • ClinicalTrials.gov ID: NCT05025865

Registry updated: 2026-09-24
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Description

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.

Interventions

  • Sodium Hyaluronate (Drug)
    Sodium Hyaluronate of molecular weight 35 kDa will be given in capsule form to the study participants.
  • Placebo (Drug)
    A placebo will be given in capsule form to study participants.

Eligibility criteria

Inclusion Criteria: * 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 Exclusion Criteria: * 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

Conditions

Healthy Controls

Locations

  • Cleveland Clinic — Cleveland, Ohio, United States
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record