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Colorectal CancerPhase 2ROSANNANCT06137248

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

A Phase 2 study testing Energy drink in people with Colorectal Cancer, run by University of Florida at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 40 yearsHealthy volunteers can take part
Conditions the study is for
Colorectal Cancer
What is being tested?
Energy drink
Could I receive a placebo?
No, everyone receives an active treatment
How many people
76 participants
Where
1 siteUnited States
Study dates
28 Feb 2024to 17 Apr 2025
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 40 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • University of Florida

    Gainesville, Florida, 32608

Other trials in United States

About this study

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

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.

Read the 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 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.

Being tested
Energy drink
Keywords
energy drink, sulfur, taurine, colorectal cancer, microbiota
Medical subject headings
Colorectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Energy drinkDietary supplement

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

Study groups in NCT06137248
Study groupRoleWhat they receive
Energy drink interventionExperimentalNot described
Receives: Dietary Supplement: Energy drink
Control armNo interventionParticipants on this arm will only consume their normal diet for 4 weeks.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 4 weeks

Secondary outcomes (5)
  1. 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

    Measured: 4 weeks

  2. Microbiome changes

    Determine the concordance of microbiome changes in participant stool samples with dietary logs

    Measured: 4 weeks

  3. 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

    Measured: 4 weeks

  4. 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

    Measured: 4 weeks

  5. 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

    Measured: 4 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Nov 2023
  2. Study start28 Feb 2024
  3. Primary completion17 Apr 2025
  4. Study completion17 Apr 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
76 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06137248
Sponsor's protocol ID
UF-CCPS-037
Other IDs
OCR43110, IRB202301911
Acronym
ROSANNA
Status last verified
May 2025
First submitted
13 Nov 2023
Last updated
6 May 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Energy drink in people with Colorectal Cancer, run by University of Florida at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in the hydrogen sulfide-metabolizing species of bacteria (time frame: 4 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2025.

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