RecruitingEarly Phase 1NCT05025865

HA35 Acute Alcohol Study

Mechanisms by Which HA35 Regulates Muscle Protein Homeostasis in Healthy Controls

Sponsor

The Cleveland Clinic

Enrollment

24 participants

Start Date

Feb 1, 2022

Study Type

INTERVENTIONAL

Conditions

Healthy (Controls)

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.

Eligibility

Min Age: 21 YearsMax Age: 65 Years

Inclusion Criteria2

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 Criteria13

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