HA35 Acute Alcohol Study
ConditionHealthy Controls
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age21-65
SponsorThe Cleveland Clinic
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Sodium Hyaluronate
- Placebo
Treatment groups
24 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov