HA35 Acute Alcohol Study

NCT ID: NCT05025865

Last Updated: 2025-11-17

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-02-01
• Study Completion Date: 2027-10-01

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: TRIPLE

Study Groups

HA35 Placebo Group

12 study participants will be given a placebo capsule to take once per day in the morning with breakfast for 3 days.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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

HA35 Treatment Group

12 study participants will be given an HA35 capsule to take once per day in the morning with breakfast for 3 days.

Group Type: ACTIVE_COMPARATOR

Sodium Hyaluronate

Intervention Type: DRUG

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

Interventions

Sodium Hyaluronate

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

Intervention Type: DRUG

Placebo

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

Intervention Type: DRUG

Other Intervention Names

HA35

Eligibility Criteria

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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

The Cleveland Clinic

OTHER

Sponsor Role: lead

Responsible Party

Srinivasan Dasarathy

Staff Physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Cleveland Clinic

Cleveland, Ohio, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Srinivasan Dasarathy, MD

Role: CONTACT

dasaras@ccf.org

216-318-7010

Annette Bellar

Role: CONTACT

bellara@ccf.org

Facility Contacts

Annette Bellar

Role: primary

bellara@ccf.org

Other Identifiers

21-486

Identifier Type: -

Identifier Source: org_study_id