Actively Recruiting
Mechanisms by Which HA35 Regulates Muscle Protein Homeostasis in Healthy Controls
Led by The Cleveland Clinic · Updated on 2025-11-17
24
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying how Sodium Hyaluronate (HA35) affects muscle protein balance in healthy adults aged 21 to 65. The trial compares the effects of HA35 capsules to placebo capsules taken daily over a short period. This early phase 1, randomized, triple-blind study aims to understand the biological changes related to muscle health and liver enzymes after an alcohol challenge. Participants are randomly assigned to receive either HA35 or placebo capsules once each morning with breakfast for three days. On the fourth day, they undergo a study visit involving an acute ethanol challenge where they consume a measured amount of vodka mixed with juice. Muscle biopsies are taken before and after this challenge. During the visit, various tests including blood collection, gut permeability measurement using a sugar cocktail, body composition assessments, and urine and stool collections are performed. Participants will attend a screening visit with medical exams and labs, followed by the baseline visit where samples are collected and randomization occurs. The day 4 visit lasts about 3 to 4 hours and requires a designated driver to bring the participant home. On the fifth day, participants return to drop off a 24-hour urine collection. The study measures changes in liver enzymes (AST and ALT) from baseline to day 4. All study-related procedures and tests are provided at no cost to participants.
CONDITIONS
Brief Title
HA35 Acute Alcohol Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
- Age between 21 and 65 years
- Healthy adults without chronic illnesses
- Able to have a designated driver on the day of the alcohol challenge
You will not qualify if you...
- Any known chronic illness including cancer (except non-melanoma skin cancer)
- Poorly controlled diabetes (Hemoglobin A1c >9.5 g/dl)
- Untreated hyperthyroidism or hypothyroidism
- Uncontrolled hypertension or hypercholesterolemia
- End-stage renal disease
- Liver disease of any kind
- Coronary artery disease or stroke
- Active intravenous drug use
- History of gastric bypass surgery
- Use of medications that alter muscle protein synthesis (systemic corticosteroids, tamoxifen, high dose estrogen, testosterone, or anabolic steroids)
- Pregnancy
- Past alcohol use disorder
- Abnormal clotting factors
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 3 days
Participants take either HA35 or placebo capsules once daily in the morning before breakfast for 3 days prior to the day 4 visit.
Daily capsule intake at home
Duration - 1 day
On day 4, participants undergo an acute ethanol challenge with muscle biopsies, blood collections, and gut permeability testing.
1 in-person visit on day 4 with multiple procedures
Trial Site Locations
Total: 1 location
1
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Actively Recruiting
Research Team
S
Srinivasan Dasarathy, MD
A
Annette Bellar
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
BASIC_SCIENCE
Number of Arms
2
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