NCT05025865

HA35 Acute Alcohol Study

Mechanisms by Which HA35 Regulates Muscle Protein Homeostasis in Healthy Controls

• Status: Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: The Cleveland Clinic · Academic / Other
• Sex: All
• Age: 21 Years – 65 Years
• Healthy volunteers: Accepted

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.

Detailed description

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.

Conditions

• Healthy Controls

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2022-02-01
• Primary completion: 2026-10-01
• Completion: 2027-10-01
• First posted: 2021-08-27
• Last updated: 2025-11-17

Locations

1 site across 1 country: United States