Clinical trial · Interventional
Study to Assess Colonic Microbiota Changes in Response to Energy Drink Consumption
Randomized Study to Assess Colonic Microbiota Changes in Response to Energy Drink Consumption
NCT06137248CI-TRIAL-00089369ROSANNAcompletedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Energy drink | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Energy drink intervention
- interventionNames
- Dietary Supplement: Energy drink
- type
- NO_INTERVENTION
- label
- Control arm
- description
- Participants on this arm will only consume their normal diet for 4 weeks.
Primary outcomes (1)
- measure
- Change in the hydrogen sulfide-metabolizing species of bacteria
- timeFrame
- 4 weeks
- description
- 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
Secondary outcomes (5)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 40 Years
Show eligibility criteria text
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 * 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. 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
References
Publications (0)
Data not yet available
No reference posted for this study.