Skip to main content
Update Location

My Location

Update your location to show providers, locations, and services closest to you.

Enter a zip code
Or
Select a campus/region

ROSANNA

  • Status
    Accepting Candidates
  • Age
    18 Years - 40 Years
  • Sexes
    All
  • Healthy Volunteers
    Accepts Healthy Volunteers

Objective

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.

Details

Full study title Randomized Study to Assess Colonic Microbiota Changes in Response to Energy Drink Consumption (ROSANNA)
Protocol number OCR43110
ClinicalTrials.gov ID NCT06137248
Phase Phase 2

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

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

Lead researcher

  • Thomas J George, MD, FACP, FASCO
    Cancer Specialist (Oncologist), Hematology and Oncology Specialist

Participate in a study

Here are some general steps to consider when participating in a research study:

  1. Step
    1

    Contact the research team

    Call or email the research team listed within the specific clinical trial or study to let them know that you're interested. A member of the research team, such as the researcher or study coordinator, will be available to tell you more about the study and to answer any questions or concerns you may have.

    Primary contact

  2. Step
    2

    Get screened to confirm eligibility

    You may be asked to take part in prescreening to make sure you are eligible for a study. The prescreening process ensures it is safe for you to participate. During the prescreening process, you will be asked some questions and you may also be asked to schedule tests or procedures to confirm your eligibility.

  3. Step
    3

    Provide your consent to participate

    If you are eligible and want to join the clinical trial or study, a member of the research team will ask for your consent to participate. To give consent, you will be asked to read and sign a consent form for the study. This consent form explains the study's purpose, procedures, risks, benefits and provides other important information, such as the study team's contact information.

  4. Step
    4

    Participate

    If you decide to participate in a clinical trial or study, the research team will keep you informed of the study requirements and what you will need to do to throughout the study. For some trials or studies, your health care provider may work with the research team to ensure there are no conflicts with other medications or treatments.