ROSANNA: Study to Assess Colonic Microbiota Changes in Response to Energy Drink Consumption

Sponsor

University of Florida (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06137248

Collaborator

McJunkin Family Charitable Foundation (Other)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Colorectal Cancer	Dietary Supplement: Energy drink	Phase 2

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 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

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

Randomized Study to Assess Colonic Microbiota Changes in Response to Energy Drink Consumption

Anticipated Study Start Date :

Feb 1, 2024

Anticipated Primary Completion Date :

Feb 1, 2025

Anticipated Study Completion Date :

Feb 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Energy drink 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.
No Intervention: Control arm Participants on this arm will only consume their normal diet for 4 weeks.

Arm

Intervention/Treatment

Experimental: Energy drink 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.

No Intervention: Control arm

Participants on this arm will only consume their normal diet for 4 weeks.

Outcome Measures

Primary Outcome Measures

Change in the hydrogen sulfide-metabolizing species of bacteria [4 weeks]
Determine the change in the hydrogen sulfide-metabolizing species of bacteria between baseline and study completion in those receiving the energy drink intervention compared to the control group, as measured by the change in the sulfur-metabolizing bacterial communities value in the stool

Secondary Outcome Measures

Changes in colonic microbiota [4 weeks]
Determine changes to the colonic microbiota in participant stool samples between baseline and study completion and associated subject demographic differences and dietary intake
Microbiome changes [4 weeks]
Determine the concordance of microbiome changes in participant stool samples with dietary logs
Overall change in microbial diversity [4 weeks]
Determine overall change in microbial diversity in participant stool between baseline and study completion as measured by change in alpha diversity
Overall change in microbial diversity [4 weeks]
Determine overall change in microbial diversity in participant stool between baseline and study completion as measured by change in Shannon diversity index
Microbiome changes and tolerance [4 weeks]
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 40 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

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