Completed

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

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What is being tested

Energy drink

Dietary Supplement
Who is being recruted

Colonic Diseases+8

+ Digestive System Diseases

+ Digestive System Neoplasms

From 18 to 40 Years
+13 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Basic Science Study

Phase 2
Interventional
Study Start: February 2024
See protocol details

Summary

Principal SponsorUniversity of Florida
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: February 28, 2024

Actual date on which the first participant was enrolled.

This study is focused on understanding how drinking energy drinks might change the bacteria in the gut, potentially increasing the risk of colorectal cancer, especially in younger adults. Colorectal cancer is a major health concern, and the rates are rising in individuals under 50 years old. Researchers are exploring if high taurine levels in energy drinks could promote certain gut bacteria that produce hydrogen sulfide, a compound that may contribute to cancer development. By exploring this connection, the study aims to uncover new ways to prevent or manage early-onset colorectal cancer. Participants in the study will consume energy drinks, and researchers will monitor changes in their gut bacteria. The study will check if the taurine in energy drinks encourages the growth of hydrogen sulfide-producing bacteria. The results will help determine if there is a significant increase in these bacteria, which could be linked to higher cancer risk. Understanding these changes is crucial for developing potential strategies to reduce colorectal cancer risk associated with diet and lifestyle factors.

Official TitleRandomized Study to Assess Colonic Microbiota Changes in Response to Energy Drink Consumption
NCT06137248
Principal SponsorUniversity of Florida
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

76 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Basic Science Study

Basic science studies help researchers understand how the body works or how a disease develops. They don't test treatments, but they build the foundation for future therapies.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 40 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Colonic DiseasesDigestive System DiseasesDigestive System NeoplasmsGastrointestinal DiseasesGastrointestinal NeoplasmsIntestinal DiseasesIntestinal NeoplasmsNeoplasmsNeoplasms by SiteRectal DiseasesColorectal Neoplasms

Criteria

5 inclusion criteria required to participate
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

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8 exclusion criteria prevent from participating
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

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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

University of Florida

Gainesville, United StatesOpen University of Florida in Google Maps
CompletedOne Study Center