Evaluating the effects of HA35 on gut permeability and muscle response to alcohol
Mechanisms by Which HA35 Regulates Muscle Protein Homeostasis in Healthy Controls
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 |
| Enrollment | 24 (estimated) |
| Ages | 21 Years to 65 Years |
| Sex | All |
| Sponsor | The Cleveland Clinic Academic / other |
| Locations | 1 site (Cleveland, Ohio) |
| Trial ID | NCT05025865 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are healthy adults who consume low amounts of alcohol and meet specific health criteria.
Not a fit: Patients with chronic illnesses, uncontrolled conditions, or a history of alcohol use disorder may not benefit from this study.
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 performed: While there have been studies on gut permeability and alcohol effects, this specific approach using HA35 is novel and has not been extensively tested.
Eligibility criteria
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 this trial is running
Cleveland, Ohio
- Cleveland Clinic — Cleveland, Ohio, United States (Recruiting)
Study contacts
- Study coordinator: Srinivasan Dasarathy, MD
- Email: dasaras@ccf.org
- Phone: 216-318-7010
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.