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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06137248
Other study ID # UF-CCPS-037
Secondary ID OCR43110
Status Recruiting
Phase Phase 2
First received
Last updated
Start date February 28, 2024
Est. completion date February 2025

Study information

Verified date June 2024
Source University of Florida
Contact Judy Walsh
Phone (352) 294-8615
Email PMO@cancer.ufl.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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 disease. However, rates of colorectal cancer have been slowly increasing in incidence in those younger than 50, recently prompting the U.S. Preventative Services Task Force to recommend reducing the age of routine screening to 45. The reason for the rising incidence of CRC in younger individuals (eoCRC) is unclear but with many speculative causes postulated. One of the most frequently cited possible causes relates to changes in the young adult colonic microbiome which either removes a protective mechanism or promotes a carcinogenic process. The latter is the hypothesis being persued. Certain commensal bacteria produce hydrogen sulfide (H2S) during fermentation of sulfate containing compounds such as sulfur amino acids. For example, Fusobacterium nucleatum produces H2S from metabolizing methionine and cysteine. Atopobium parvulum is another potent H2S producer and is implicated in halitosis. Importantly, H2S has the capacity to induce inflammation and possesses genotoxic and potentially pro-tumorigenic properties, particularly when consistently present over a prolonged period of time. While Fusobacterium and Atopobium are minor members of the normal gut microbiota, recent studies showed that they are overrepresented in CRC patients. The invvestigators published that the relative abundance of A. parvulum was positively correlated with the severity of pediatric inflammatory bowel disease (IBD). Moreover, the investigators observed that Il10-/- mice colonized by A. parvulum developed severe colitis, which was attenuated by a chow diet containing the H2S scavenger bismuth. Together, this data suggests that bacteria-derived H2S may contribute to intestinal pathologies including the creation of a pro-inflammatory and pro-carcinogenic environment, which could be modulated by availability of dietary sulfur contents. One major energy source for H2S producing gut microbiota is taurine, an essential amino acid found in very high levels/concentrations in energy drinks. The typical American diet provides between 123 and 178 mg of taurine daily. However, consumption of one 8-oz energy drink can increase the average taurine intake 6 to 16 times that our regular diet. The hypothesis being persued is that energy-drinks, through their high taurine content, favors expansion of already present bacteria producing H2S, thereby representing an association with a carcinogenic risk-factor that might help explain the rise in eoCRC cases and developing future interventions to mitigate this risk.


Recruitment information / eligibility

Status Recruiting
Enrollment 60
Est. completion date February 2025
Est. primary completion date February 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 40 Years
Eligibility Inclusion Criteria: - 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 Criteria: - 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

Study Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
Energy drink
Participants on this arm will consume an energy drink once daily in addition to their normal diet for 4 weeks.

Locations

Country Name City State
United States University of Florida Gainesville Florida

Sponsors (2)

Lead Sponsor Collaborator
University of Florida McJunkin Family Charitable Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in the hydrogen sulfide-metabolizing species of bacteria Determine the change in the hydrogen sulfide-metabolizing species of bacteria in those receiving the energy drink intervention compared to the control group, as measured by the change from baseline to 1 month post-intervention in the sulfur-metabolizing bacterial communities value in the stool 4 weeks
Secondary Changes in colonic microbiota Determine changes to the colonic microbiota in participant stool samples between baseline and study completion and associated subject demographic differences and dietary intake 4 weeks
Secondary Microbiome changes Determine the concordance of microbiome changes in participant stool samples with dietary logs 4 weeks
Secondary Overall change in microbial diversity Determine overall change in microbial diversity in participant stool between baseline and study completion as measured by change in alpha diversity 4 weeks
Secondary Overall change in microbial diversity Determine overall change in microbial diversity in participant stool between baseline and study completion as measured by change in Shannon diversity index 4 weeks
Secondary Microbiome changes and tolerance 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 4 weeks
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