Energy Drinks and Gut Bacteria Changes

(ROSANNA Trial)

Recruiting in Palo Alto (17 mi)

Overseen by Thomas J. George

Age: 18 - 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: University of Florida

Must not be taking: Probiotics, Antibiotics

Disqualifiers: Colorectal cancer, IBD, Chronic diarrhea, others

No Placebo Group

Prior Safety Data

Approved in 6 Jurisdictions

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. However, if you are taking probiotics or have used antibiotics in the past 28 days, you may not be eligible to participate.

What data supports the effectiveness of the treatment Energy Drink, Sports Drink, Electrolyte Drink, Pep Drink, Recovery Drink, Isotonic Drink, Thirst Quencher, Power Beverage, Stimulant Drink?

Research suggests that drinks containing carbohydrates and electrolytes can help maintain energy balance during exercise and aid in recovery by replenishing lost nutrients and fluids. These types of drinks are effective in enhancing physical endurance and rehydration, which may indirectly support gut health by maintaining overall body function. ^{1 2 3 4 5}

How does the energy drink treatment differ from other treatments for gut bacteria changes?

Energy drinks are unique in this context because they contain sugars and ingredients like caffeine and taurine, which can influence gut bacteria differently than traditional treatments. Unlike standard treatments, energy drinks are consumed as beverages and are not specifically designed to target gut bacteria, making their effects on gut health indirect and potentially variable. ^{5 6 7 8 9}

Research Team

Thomas J. George

Principal Investigator

University of Florida

Eligibility Criteria

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.

Inclusion Criteria

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 and the subject agrees to comply with all the study-related procedures

Exclusion Criteria

Regular (daily) intake of probiotics

Known intolerance of or sensitivity to caffeine

I have had colorectal cancer in the past.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants consume energy drinks or maintain their normal diet for 4 weeks to assess changes in colonic microbiota

4 weeks

Follow-up

Participants are monitored for changes in microbiome and hydrogen sulfide-metabolizing species post-intervention

4 weeks

Treatment Details

Interventions

• Energy Drink (Other)

Trial Overview 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.

Participant Groups

Group I: Energy drink intervention Experimental Treatment 1 Intervention

Group II: Control arm Active Control 1 Intervention

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

Energy Drink is already approved in Canada, Japan, China, Switzerland for the following indications:

Approved in Canada as Energy Drink for:

• General Health and Wellness
• Physical Performance Enhancement
• Mental Alertness

Approved in Japan as Energy Drink for:

• General Health and Wellness
• Physical Performance Enhancement
• Mental Alertness

Approved in China as Energy Drink for:

• General Health and Wellness
• Physical Performance Enhancement
• Mental Alertness

Approved in Switzerland as Energy Drink for:

• General Health and Wellness
• Physical Performance Enhancement
• Mental Alertness

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

University of Florida Gainesville, FL

Who Is Running the Clinical Trial?

University of Florida

Lead Sponsor

Trials

1428

Patients Recruited

987,000+

McJunkin Family Charitable Foundation

Collaborator

Trials

1

Patients Recruited

60+

Findings from Research

Oral supplementation with a carbohydrate-electrolyte drink significantly improved endurance performance and heart rate responses in national level male athletes during exercise at 70% VO2max, indicating its efficacy in enhancing sports performance.

The carbohydrate-electrolyte drink also facilitated better lactate removal and improved cardiovascular responses during recovery, suggesting it helps delay fatigue and supports recovery after intense exercise.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Supplementary effect of carbohydrate-electrolyte drink on sports performance, lactate removal & cardiovascular response of athletes. Khanna, GL., Manna, I.[2013]

Rehydration solutions that contain water, carbohydrates, and electrolytes are most effective for recovering from dehydration, as they enhance the absorption of fluids and nutrients.

Properly balanced rehydration beverages not only restore electrolyte balance and carbohydrates but also improve physical endurance and reduce stress during recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Dehydration and rehydration of the human body. Physiopathologic and clinical considerations]. Formenti, A., Vittadini, G.[2006]

Energy drinks, which are high in caffeine and sugar, have become increasingly popular among adolescents, raising concerns due to their potential for serious health risks, including sleep disturbances and even death.

The consumption of energy drinks among youth is associated with higher likelihoods of using tobacco, alcohol, and illicit drugs, indicating a troubling pattern of risky behaviors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Risk of Energy Drink Consumption to Adolescent Health. Ruiz, LD., Scherr, RE.[2023]

Energy drinks, which often contain caffeine, taurine, and other ingredients, can have both positive and negative effects on physical and cognitive performance, but the safety of these ingredients, especially in youths, remains a concern.

The combination of energy drinks with alcohol is particularly risky for young people, as it can lead to increased rates of alcohol-related consequences, including serious injuries and impaired judgment, despite subjective feelings of reduced intoxication.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Risks of energy drinks in youths]. Bigard, AX.[2022]

Energy drinks are becoming increasingly popular, but there is limited public knowledge about their ingredients and physiological effects, highlighting a gap in consumer awareness.

The article reviews the contents and effects of various energy drinks, emphasizing the need for more detailed research on their physical and mental impacts, as well as the limitations associated with their consumption.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[The history, ingredients and effects of energy drinks]. Grósz, A., Szatmári, A.[2021]

A survey of 120 university athletes in Saudi Arabia revealed that many athletes use energy drinks (EDs) primarily for energy boosts, while sports drinks (SDs) are often believed to aid in recovery, highlighting a need for better education on the purposes and effects of these beverages.

Microbiological testing of 26 local drinks showed that while most had low levels of microbial contamination, two products did show contamination, indicating that improvements in the safety and quality of these drinks are necessary to prevent potential health risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Knowledge and Behavior of Saudi College Athletes toward Energy and Sports Drinks with an Emphasis on Microbial Quality and Safety. Aljaloud, SO.[2023]

References

1. India pubmed.ncbi.nlm.nih.gov

Supplementary effect of carbohydrate-electrolyte drink on sports performance, lactate removal & cardiovascular response of athletes. [2013]

2. United States pubmed.ncbi.nlm.nih.gov

Building a beverage for recovery from endurance activity: a review. [2016]

3. Italy pubmed.ncbi.nlm.nih.gov

[Dehydration and rehydration of the human body. Physiopathologic and clinical considerations]. [2006]

4. United States pubmed.ncbi.nlm.nih.gov

Risk of Energy Drink Consumption to Adolescent Health. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

In Vitro Effects of Sports and Energy Drinks on Streptococcus mutans Biofilm Formation and Metabolic Activity. [2018]

6. France pubmed.ncbi.nlm.nih.gov

[Risks of energy drinks in youths]. [2022]

7. Hungary pubmed.ncbi.nlm.nih.gov

[The history, ingredients and effects of energy drinks]. [2021]

8. Venezuela pubmed.ncbi.nlm.nih.gov

[Development and optimization of an isotonic sports drink]. [2016]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Knowledge and Behavior of Saudi College Athletes toward Energy and Sports Drinks with an Emphasis on Microbial Quality and Safety. [2023]