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

NCT06137248 | Completed Phase 2

• 3 other identifiers: UF-CCPS-037OCR43110IRB202301911
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Colorectal Cancer

Keywords

energy drink; sulfur; taurine; colorectal cancer; microbiota

Outcome Measures

Primary Outcomes (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

  4 weeks

Secondary Outcomes (5)

• Changes in colonic microbiota

  4 weeks

• Microbiome changes

  4 weeks

• Overall change in microbial diversity

  4 weeks

• Overall change in microbial diversity

  4 weeks

• Microbiome changes and tolerance

  4 weeks

Study Arms (2)

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.

Interventions

Energy drink DIETARY_SUPPLEMENT

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

Energy drink intervention

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Florida: lead
• McJunkin Family Charitable Foundation: collaborator

Study Sites (1)

University of Florida

Gainesville, Florida, 32608, United States

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Energy Drinks

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Beverages; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Thomas George, MD

  University of Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 13, 2023
• First Posted: November 18, 2023
• Study Start: February 28, 2024
• Primary Completion: April 17, 2025
• Study Completion: April 17, 2025
• Last Updated: May 6, 2025

Record last verified: 2025-05

Locations

US (1)