HA35 Acute Alcohol Study

ConditionHealthy Controls

Trial statusRecruiting

Trial phaseEarly Phase 1

Trial typeInterventional

Biological sexAll

Age21-65

SponsorThe Cleveland Clinic

About this trial

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 criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

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.

Treatment groups

24 Participants

are divided into 2 treatment groups

Group A: HA35 Placebo GroupPlacebo comparator 1 intervention

Group B: HA35 Treatment GroupActive comparator 1 intervention

Trial outcomes

Primary outcomes

Change in Aspartate Aminotransferase (AST)

change in units/liter (U/L)

Time frame

Baseline to day 4

Change in Alanine Aminotransferase (ALT)

change in units/liter (U/L)

Time frame

Baseline to day 4

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

The Cleveland Clinic

Lead sponsor

Source ClinicalTrials.gov

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