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RECRUITING
NCT05025865
EARLY_PHASE1

HA35 Acute Alcohol Study

Sponsor: The Cleveland Clinic

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

21 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

24

Start Date

2022-02-01

Completion Date

2027-10-01

Last Updated

2025-11-17

Healthy Volunteers

Yes

Interventions

DRUG

Sodium Hyaluronate

Sodium Hyaluronate of molecular weight 35 kDa will be given in capsule form to the study participants.

DRUG

Placebo

A placebo will be given in capsule form to study participants.

Locations (1)

Cleveland Clinic

Cleveland, Ohio, United States