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At a Glance
Age
21 – 65
Sex
Any
Trial phase
Early Phase 1
Study type
Interventional
Purpose
Basic Science
Participants needed
24 (estimated)
Sponsor
The Cleveland Clinic · Other
Who this trial is looking for
This trial is looking for healthy adults who consume low amounts of alcohol. Participants will take capsules for three days, undergo various health tests, and return for follow-up on the fifth day.
Are You a Good Fit for This Trial?
Must not be takingSystemic corticosteroidsTamoxifenHigh dose estrogenTestosteroneAnabolic steroids
Rules you outActive intravenous drug usePregnancyPast alcohol use disorderAbnormal clotting factors
You may be able to join if
I drink less than 7 alcoholic drinks per week if I'm a woman
I drink less than 14 alcoholic drinks per week if I'm a man
I can understand information and provide written consent
You may not be able to join if
I have a chronic illness such as cancer
I have poorly controlled diabetes
I have untreated thyroid problems
I have uncontrolled high blood pressure or cholesterol
I have end-stage kidney disease
I have liver disease
I have coronary artery disease or a history of stroke
I have a history of gastric bypass
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
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Answer a few quick questions to see if you may meet the eligibility requirements.
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 ac…
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.
Trial Locations
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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 s…
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
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