This clinical trial evaluates how energy drink consumption alters the microorganisms (microbiome) found in the colon in health individuals. Most patients who develop colorectal cancer are diagnosed after the age of 50. However, rates of colorectal cancer have been slowly increasing in people younger than 50. The reason for increasing rates of colorectal cancer among younger individuals is unclear, but one possible cause is changes to the microbiome of the colon. Patients with colorectal cancer have been shown to have high amounts of bacteria that produce a chemical called hydrogen sulfide, which may contribute to the development of colorectal cancer. Some energy drinks contain an ingredient called taurine, which is an amino acid that can be used as an energy source by bacteria that produce hydrogen sulfide. The consumption of taurine via energy drinks may increase the number of hydrogen sulfide-producing bacteria in the colon, which may represent a risk factor for colorectal cancer.
Additional locations may be listed on ClinicalTrials.gov for NCT06137248.
See trial information on ClinicalTrials.gov for a list of participating sites.
PRIMARY OBJECTIVE:
I. To determine the change in the hydrogen sulfide (H2S)-metabolizing species of bacteria between baseline and study completion in the experimental compared to the control group.
SECONDARY OBJECTIVES:
I. To determine changes to the colonic microbiota and associated subject demographic differences and dietary intake.
II. To determine overall changes in microbial diversity and specific speciation between baseline and follow-up assessments (alpha and beta diversity, Shannon diversity index, and Jensen-Shannon distance).
III. To determine the concordance of microbiome changes with dietary logs.
IV. To determine subgroup analyses between the two arms regarding microbiome changes and tolerance with regards to gender, race, ethnicity, and baseline dietary meat/seafood/energy drink consumption.
EXPLORATORY OBJECTIVES:
I. Describe the degree of specific colonic microbiome changes following the short-term consumption of energy drinks in young adults.
II. Exploratory analysis of sulfur production in a subset of specimens.
III. Exploratory biologic analyses of metabolic and immune function.
IV. Concordance and changes in other microbiome ecosystems (i.e., buccal, urine, skin).
V. Descriptive analysis of compliance with different study components.
OUTLINE: Participants are randomized to 1 of 2 arms.
ARM A: Participants consume energy drinks once daily (QD) for 4 weeks. Participants also undergo collection of blood, urine, buccal, skin, and stool samples throughout the study.
ARM B: Participants follow their usual diet for 4 weeks. Participants also undergo collection of blood, urine, buccal, skin, and stool samples throughout the study.
After completion of study intervention, participants are followed up in week 5.
Trial PhaseNo phase specified
Trial Typebasic science
Lead OrganizationUniversity of Florida Health Science Center - Gainesville
Principal InvestigatorThomas J. George
