HA35 Acute Alcohol Study

Study Overview
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Brief Summary
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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.

Detailed Description
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Interested subjects will be assessed for eligibility and a written informed consent will be obtained. The screening visit will consist of a medical exam, clinical labs (if not available in medical record), and questionnaires. Those who pass the screening will be eligible for a baseline visit (may be combined with screening if appropriate labs are already done). The baseline visit will include collection of blood, urine, and stool samples, body composition measurements, and randomization into either HA35 or placebo groups. Patients will be instructed to take the HA35 or placebo daily in the morning before breakfast 3 days prior to the day 4 visit. Patients will be informed that they will need to have a driver that is known to them for the day 4 visit. In the morning of the day 4 visit, confirmation of a driver will occur prior to starting study procedures. During the day 4 visit, patients will have an acute ethanol challenge where they will need to consume 2mL/kg of vodka in 100mL of juice in under 60 minutes. Muscle biopsies will be collected before and after the challenge and blood will be collected throughout the day. In addition, patients will be given lactulose/mannitol/sucralose/sucrose cocktail to measure gut permeability. The costs of any of these tests/procedures will not be billed to the patient and will be covered by the department. The participant will not be responsible for any costs.

Official Title
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Mechanisms by Which HA35 Regulates Muscle Protein Homeostasis in Healthy Controls

Conditions
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Healthy Controls

Intervention / Treatment
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* Drug: Sodium Hyaluronate
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: HA35 Placebo Group<br>12 study participants will be given a placebo capsule to take once per day in the morning with breakfast for 3 days. | Drug: Placebo<br>* A placebo will be given in capsule form to study participants.<br>|
| Active Comparator: HA35 Treatment Group<br>12 study participants will be given an HA35 capsule to take once per day in the morning with breakfast for 3 days. | Drug: Sodium Hyaluronate<br>* Sodium Hyaluronate of molecular weight 35 kDa will be given in capsule form to the study participants.<br>* Other names: HA35;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Aspartate Aminotransferase (AST) | change in units/liter (U/L) | Baseline to day 4 | 
| Change in Alanine Aminotransferase (ALT) | change in units/liter (U/L) | Baseline to day 4 |