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HA35 Acute Alcohol Study

Sponsor
The Cleveland Clinic (Other)
Overall Status
Recruiting
CT.gov ID
NCT05025865
Collaborator
(none)
24
Enrollment
1
Location
2
Arms
32
Anticipated Duration (Months)
0.8
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Sodium Hyaluronate
  • Drug: Placebo
 Early Phase 1

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
24 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Primary Purpose:
Basic Science
Official Title:
Mechanisms by Which HA35 Regulates Muscle Protein Homeostasis in Healthy Controls
Actual Study Start Date :
Feb 1, 2022
Anticipated Primary Completion Date :
Oct 1, 2023
Anticipated Study Completion Date :
Oct 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Placebo Comparator: 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.

Drug: Placebo
A placebo will be given in capsule form to study participants.
Active Comparator: 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.

Drug: Sodium Hyaluronate
Sodium Hyaluronate of molecular weight 35 kDa will be given in capsule form to the study participants.
Other Names:
  • HA35

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Change in Aspartate Aminotransferase (AST) [Baseline to day 4]

      change in units/liter (U/L)

    2. Change in Alanine Aminotransferase (ALT) [Baseline to day 4]

      change in units/liter (U/L)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    21 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Cleveland Clinic Cleveland Ohio United States 44195

    Sponsors and Collaborators

    • The Cleveland Clinic

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Srinivasan Dasarathy, Staff Physician, The Cleveland Clinic
    ClinicalTrials.gov Identifier:
    NCT05025865
    Other Study ID Numbers:
    • 21-486
    First Posted:
    Aug 27, 2021
    Last Update Posted:
    May 9, 2022
    Last Verified:
    May 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Hyaluronic Acid

    Study Results

    No Results Posted as of May 9, 2022