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Energy drink intervention for Colorectal Cancer (ROSANNA Trial)

Phase 2

Recruiting

Led By Thomas George, MD

Research Sponsored by University of Florida

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Adults aged 18 to 40 years

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 4 weeks

Awards & highlights

ROSANNA Trial Summary

"This trial will look at whether drinking energy drinks daily for a short period of time leads to more bacteria that produce hydrogen sulfide in adults aged 18-40."

Who is the study for?

This trial is for adults between 18 and 40 years old who currently drink no more than two energy drinks per week. Participants must be willing to give written consent, follow the study procedures, and complete necessary surveys and specimen assessments.Check my eligibility

What is being tested?

The study is looking at how drinking an energy drink every day for a short period affects the types of bacteria in the colon that produce hydrogen sulfide, which could have implications for colorectal health.See study design

What are the potential side effects?

While not explicitly listed, potential side effects from daily consumption of energy drinks may include jitteriness, increased heart rate, trouble sleeping, digestive discomfort, and anxiety.

ROSANNA Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am between 18 and 40 years old.

ROSANNA Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 4 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~4 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in the hydrogen sulfide-metabolizing species of bacteria

Secondary outcome measures

Changes in colonic microbiota

Microbiome changes

Microbiome changes and tolerance

+1 more

ROSANNA Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Energy drink interventionExperimental Treatment1 Intervention

Group II: Control armActive Control1 Intervention

Participants on this arm will only consume their normal diet for 4 weeks.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Energy drink

2016

Completed Phase 1

~270

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of FloridaLead Sponsor

1,341 Previous Clinical Trials

715,586 Total Patients Enrolled

McJunkin Family Charitable FoundationUNKNOWN

Thomas George, MDPrincipal InvestigatorUniversity of Florida

1 Previous Clinical Trials

45 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the current number of individuals being recruited for participation in this clinical research study?

"The information sourced from clinicaltrials.gov confirms that this medical study is actively seeking volunteers. The trial was initially shared on February 1, 2024, and most recently revised on February 7, 2024. It aims to enroll a total of 60 participants across one designated site."

Answered by AI

Has the intervention of energy drinks received approval from the FDA?

"Our team at Power has assessed the safety of the Energy drink intervention as a 2 on the scale, considering this trial is in Phase 2 with existing data supporting safety but not efficacy."

Answered by AI

Does this research include individuals who are older than 80 years old?

"Patients eligible for this research endeavor must fall within the age bracket of 18 to 40 years. It is noteworthy that there are a total of 36 investigations catering to individuals younger than 18, and an extensive number of 1123 studies targeting those above the age of 65."

Answered by AI

Are individuals currently able to apply and participate in this ongoing research study?

"According to the details on clinicaltrials.gov, this investigation is currently in search of suitable participants. The initial posting date for this trial was February 1st, 2024, and it was most recently revised on February 7th, 2024."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2024. "Study to Assess Colonic Microbiota Changes in Response to Energy Drink Consumption". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06137248.