What this study is
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.
What's being tested
- Sodium Hyaluronate
Intervention · DRUG
Sodium Hyaluronate of molecular weight 35 kDa will be given in capsule form to the study participants.
- Placebo
Intervention · DRUG
A placebo will be given in capsule form to study participants.
Study details
- Official title
- Mechanisms by Which HA35 Regulates Muscle Protein Homeostasis in Healthy Controls
- Sponsor
- The Cleveland Clinic
- Conditions
- Healthy Controls
- Enrolling
- 24 people
- Starts
- 2022-02-01
- Est. completion
- 2028-10-01
- Design
- Triple-blind, randomized, parallel groups, Early Phase 1
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 21 Years – 65 YearsSex ALLHealthy volunteers AcceptedYou may qualify if
- 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
You can't join if
- 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
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 open- Recruiting
Study team
Sponsor
The Cleveland Clinic
Study ID 21-486
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.