HA35 Acute Alcohol Study

Last updated: January 8, 2025
Sponsor: The Cleveland Clinic
Overall Status: Active - Recruiting

Phase

1

Condition

Healthy Volunteers

Treatment

Placebo

Sodium Hyaluronate

Clinical Study ID

NCT05025865
21-486
  • Ages 21-65
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Alcohol consumption of less than 7 drinks per week for women and less than 14 drinksper week for men

  • Ability to understand and willingness to provide written consent

Exclusion

Exclusion Criteria:

  • Any known chronic illness including but not limited to cancer (except non-melanomaskin 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

Study Design

Total Participants: 24
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 1
Study Start date:
February 01, 2022
Estimated Completion Date:
October 01, 2026

Study 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.

Connect with a study center

  • Cleveland Clinic

    Cleveland, Ohio 44195
    United States

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.