Study of HA35 Capsules to Understand Muscle Protein Regulation in Healthy Adults Aged 21 to 65

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.

HA35 Acute Alcohol Study