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HA35 Acute Alcohol Study
Mechanisms by Which HA35 Regulates Muscle Protein Homeostasis in Healthy Controls
Who can join
Ages 21 to 65 · All sexes · Healthy volunteers welcome
Full 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
About the study
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.
What is being tested
- Sodium Hyaluronate (drug)
- Placebo (drug)
Sponsor: The Cleveland Clinic · Participants: 24 · Started: Feb 1, 2022
Contact the study team
- Srinivasan Dasarathy, MD · Phone: 216-318-7010
Official record on ClinicalTrials.gov — NCT05025865
Locations in the U.S.
| Ohio | Cleveland Clinic, Cleveland |
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.