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.
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.
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.
- Conditions
- Colorectal Cancer
- 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 group | Role | What they receive |
|---|---|---|
| Energy drink intervention | Experimental | Not described Receives: Dietary Supplement: Energy drink |
| Control arm | No intervention | Participants 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.
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)
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
Microbiome changes
Determine the concordance of microbiome changes in participant stool samples with dietary logs
Measured: 4 weeks
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
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
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.
- First posted18 Nov 2023
- Study start28 Feb 2024
- Primary completion17 Apr 2025
- Study completion17 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Collaborators
- McJunkin Family Charitable Foundation
- Responsible party
- Sponsor
- Investigators
- Thomas George, MD, Principal investigator, University of Florida
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
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Study to Assess Colonic Microbiota Changes in Response to Energy Drink Consumption
- ClinicalTrials.gov ID
- NCT06137248
- Acronym / sponsor ID
- ROSANNA / UF-CCPS-037
- Conditions
- Colorectal Cancer
- Keywords
- energy drink, sulfur, taurine, colorectal cancer, microbiota
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Collaborators
- McJunkin Family Charitable Foundation
- Study start
- 28 Feb 2024 (actual)
- Primary completion
- 17 Apr 2025 (actual)
- Study completion
- 17 Apr 2025 (actual)
- First posted
- 18 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Energy drink intervention | Experimental | Dietary Supplement: Energy drink |
| Control arm | No intervention | –Participants on this arm will only consume their normal diet for 4 weeks. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (8 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Energy drinkParticipants on this arm will consume an energy drink once daily in addition to their normal diet for 4 weeks. | Dietary supplement | Energy drink intervention |
Primary outcome
Change in the hydrogen sulfide-metabolizing species of bacteria
Time frame: 4 weeks
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
5 secondary outcomes
Changes in colonic microbiota
Time frame: 4 weeks
Microbiome changes
Time frame: 4 weeks
Overall change in microbial diversity
Time frame: 4 weeks
Overall change in microbial diversity
Time frame: 4 weeks
Microbiome changes and tolerance
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas George, MD principal investigator
University of Florida
1 site in 1 country: see every site and its status.
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.