HA35 Acute Alcohol Study
Mechanisms by Which HA35 Regulates Muscle Protein Homeostasis in Healthy Controls
- Healthy Controls
At a glance
- Phase
- Early phase 1
- Study type
- Interventional
- Sponsor
- The Cleveland Clinic
- Enrolment target
- 24
- Started
- 1 February 2022
- Main results due
- 1 October 2028
- Study sites
- 1
- Registry updated
- 24 September 2026
Can you take part?
- Ages 21 years to 65 years.
- Open to any sex.
- Healthy volunteers can take part.
These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.
Read the full eligibility 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
What this study is about
In the sponsor’s own words, from the registry.
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.
Study sites(1)
Cleveland Clinic
Cleveland, Ohio, United States
Recruiting
Showing 1 of 1 sites. 1 of the 1 site on this study is recruiting right now — a site can stop enrolling while the study as a whole is still open.
Source: ClinicalTrials.gov record NCT05025865. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.
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