HA35 Acute Alcohol Study

• Status: Not yet recruiting
• Trial end date: 2024-10-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: The Cleveland Clinic
• Treatments: Hyaluronic Acid

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