Evaluating the effects of HA35 on gut permeability and muscle response to alcohol
Official title: Mechanisms by Which HA35 Regulates Muscle Protein Homeostasis in Healthy Controls
Run by The Cleveland Clinic · NCT05025865 · Data updated 2026-11-12
This study is testing if a treatment called HA35 can improve gut health and how muscles respond to alcohol in healthy people.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 21 Years to 65 Years |
| Sex | All |
| Enrollment | 24 (estimated) |
| Sponsor | The Cleveland Clinic Academic / other |
| Locations | 1 site (Cleveland, Ohio) |
| Status | Recruiting |
| Started | February 1, 2022 |
| Main results expected | October 1, 2028 |
| Study ends | October 1, 2028 |
| Registry record updated | September 24, 2026 |
| Trial ID | NCT05025865 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are healthy adults who consume low amounts of alcohol and meet specific health criteria.
✕Probably not a fit
Patients with chronic illnesses, uncontrolled conditions, or a history of alcohol use disorder may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study investigates the effects of HA35, a sodium hyaluronate treatment, on gut permeability and muscle response in healthy individuals. Participants will take either HA35 or a placebo for three days before undergoing a series of assessments, including an acute ethanol challenge and muscle biopsies. The study aims to understand how HA35 influences the body's response to alcohol and gut health. Participants will be closely monitored throughout the process, and all associated costs will be covered by the research team.
Why it matters
Potential benefit: If successful, this study could provide insights into new treatments for improving gut health and muscle response in individuals with low alcohol consumption.
How similar studies have gone: While there have been studies on gut permeability and alcohol effects, this specific approach using HA35 is novel and has not been extensively tested.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
Cleveland Clinic
Cleveland, Ohio, United States Recruiting
Study contacts
- Study coordinator: Srinivasan Dasarathy, MD
- Email: dasaras@ccf.org
- Phone: 216-318-7010
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.