Status:
COMPLETED
Study to Assess Colonic Microbiota Changes in Response to Energy Drink Consumption
Lead Sponsor:
University of Florida
Collaborating Sponsors:
McJunkin Family Charitable Foundation
Conditions:
Colorectal Cancer
Eligibility:
All Genders
18-40 years
Phase:
PHASE2
Brief Summary
This study will investigate whether short-term daily energy drink consumption results in an increase in hydrogen sulfide-producing bacteria in adults 18-40 years old.
Detailed Description
Colorectal cancer (CRC) is the 2nd leading cause of cancer deaths in the US. The bulk of new diagnoses typically occurs after the age of 50 for those without personal or family histories of this disea...
Eligibility Criteria
Inclusion
- Adults ≥ 18 years of age AND ≤ 40 years of age
- Written informed consent obtained from the subject and the subject agrees to comply with all the study-related procedures
- Subject willing to complete/comply with study required specimen and survey assessments
- Current energy drink consumption of ≤2 energy drinks weekly
- Written informed consent obtained from the subject to participate in two companion biobanks: 1) Dr. Thomas George's Tumor and Biospecimen Sample Biobank and 2) Dr. Ryan Thomas's Microbiorepository for future research.
Exclusion
- Personal history of colorectal cancer (CRC)
- Inflammatory Bowel Disease (IBD)
- Chronic diarrhea or other chronic gastrointestinal (GI) problems felt to interfere with study conduct per the PI
- Regular (daily) intake of probiotics
- Oral or IV antibiotic use within the past 28 days (prior to intervention start date)
- Known intolerance of or sensitivity to caffeine
- Prisoners or subjects who are involuntarily incarcerated, or subjects who are compulsorily detained for treatment of either a psychiatric or physical illness.
- Known pregnancy at the time of enrollment
Key Trial Info
Start Date :
February 28 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 17 2025
Estimated Enrollment :
76 Patients enrolled
Trial Details
Trial ID
NCT06137248
Start Date
February 28 2024
End Date
April 17 2025
Last Update
May 6 2025
Active Locations (1)
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1
University of Florida
Gainesville, Florida, United States, 32608