HA35 Acute Alcohol Study

Mechanisms by Which HA35 Regulates Muscle Protein Homeostasis in Healthy Controls

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.

Study Overview

• Status: Recruiting
• Conditions: Healthy Controls
• Intervention / Treatment: Drug: Placebo; Drug: Sodium Hyaluronate

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 Type: Interventional
• Enrollment (Estimated): 24
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: Srinivasan Dasarathy, MD; Phone Number: 216-318-7010; Email: dasaras@ccf.org
• Study Contact Backup: Name: Annette Bellar; Email: bellara@ccf.org

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Recruiting
      • Cleveland Clinic
      • Contact: Annette Bellar; Email: bellara@ccf.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Aspartate Aminotransferase (AST)	change in units/liter (U/L)	Baseline to day 4
Change in Alanine Aminotransferase (ALT)	change in units/liter (U/L)	Baseline to day 4

Collaborators and Investigators

• Sponsor: The Cleveland Clinic

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2022
• Primary Completion (Estimated): October 1, 2025
• Study Completion (Estimated): October 1, 2026

Study Registration Dates

• First Submitted: August 18, 2021
• First Submitted That Met QC Criteria: August 24, 2021
• First Posted (Actual): August 27, 2021

Study Record Updates

• Last Update Posted (Actual): December 8, 2023
• Last Update Submitted That Met QC Criteria: December 6, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Immunologic Factors; Protective Agents; Adjuvants, Immunologic; Viscosupplements; Hyaluronic Acid
• Other Study ID Numbers: 21-486

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No