RECRUITING

HA35 Acute Alcohol Study

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Mechanisms by Which HA35 Regulates Muscle Protein Homeostasis in Healthy Controls

Quick Facts

Study Start:2022-02-01
Study Completion:2026-10-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05025865

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:21 Years to 65 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Alcohol consumption of less than 7 drinks per week for women and less than 14 drinks per week for men
  2. * Ability to understand and willingness to provide written consent
  1. * Any known chronic illness including but not limited to cancer (except non-melanoma skin cancer)
  2. * Poorly controlled diabetes (Hemoglobin A1c \>9.5 g/dl)
  3. * Untreated hyper/hypothyroidism
  4. * Uncontrolled hypertension or hypercholesterolemia
  5. * End-stage renal disease
  6. * Liver disease of any etiology
  7. * Coronary artery disease or stroke
  8. * Active intravenous drug use
  9. * History of gastric bypass
  10. * Medications known to alter muscle protein synthesis (systemic corticosteroids, tamoxifen, high dose estrogen, testosterone, or anabolic steroids)
  11. * Pregnancy
  12. * Past alcohol use disorder
  13. * Abnormal clotting factors

Contacts and Locations

Study Contact

Srinivasan Dasarathy, MD
CONTACT
216-318-7010
dasaras@ccf.org
Annette Bellar
CONTACT
bellara@ccf.org

Study Locations (Sites)

Cleveland Clinic
Cleveland, Ohio, 44195
United States

Collaborators and Investigators

Sponsor: The Cleveland Clinic

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-02-01
Study Completion Date2026-10-01

Study Record Updates

Study Start Date2022-02-01
Study Completion Date2026-10-01

Terms related to this study

Additional Relevant MeSH Terms

  • Healthy Controls