Energy Drinks and Gut Bacteria Changes

(ROSANNA Trial)

Overseen By Judy Walsh

Age: 18 - 65

Sex: Any

Trial Phase: Phase 2

Sponsor: University of Florida

Must not be taking: Probiotics, Antibiotics

Disqualifiers: Colorectal cancer, IBD, Chronic diarrhea, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 6 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 4 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how daily consumption of energy drinks over a short period might alter gut bacteria, specifically targeting an increase in bacteria that produce hydrogen sulfide. Researchers will divide participants into two groups: one will consume energy drinks, while the other will maintain their regular diet without energy drinks. This study suits adults aged 18-40 who typically consume two or fewer energy drinks per week and do not have significant gut issues like chronic diarrhea. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, allowing participants to contribute to important scientific understanding.

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.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research shows that energy drinks can impact gut health by altering the balance of bacteria in the intestines. Some studies suggest that the high sugar content in energy drinks could reduce the variety of gut bacteria, which might not benefit gut health.

Other studies have found that the caffeine in energy drinks can cause mild, temporary swelling in the body. While usually not serious, it is something to consider.

In general, energy drinks are safe for most people when consumed in moderation. However, they can have side effects, especially with high consumption or caffeine sensitivity. Always pay attention to how the body reacts to energy drinks and consult a healthcare provider if there are any concerns. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatment?

Researchers are excited about exploring how energy drinks might affect gut bacteria, which is a fresh angle compared to typical treatments for gut health that focus on probiotics or dietary changes. Unlike standard approaches, energy drinks might influence the gut microbiome through unique ingredients like caffeine, taurine, and sugar, potentially affecting bacteria in ways we haven't fully understood yet. This trial could uncover new insights into how these popular beverages impact our gut health, opening doors to novel therapeutic strategies.

What evidence suggests that energy drinks could affect gut bacteria?

This trial will compare the effects of energy drinks on gut bacteria with a control group consuming their normal diet. Research has shown that energy drinks can alter the gut microbiome, the group of bacteria in the digestive system. Studies on mice indicate that these drinks might affect nutrient absorption and energy management. One study suggested that energy drinks can create gut conditions that might increase the risk of certain health issues, such as colon cancer. Additionally, changes in gut bacteria from energy drink consumption have been linked to poorer metabolic health and obesity. While these findings mostly come from early research, they highlight possible effects on gut health from consuming energy drinks. ^{3 6 7 8 9}

Who Is on the Research Team?

Thomas J. George

Principal Investigator

University of Florida

Are You a Good Fit for This Trial?

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

Prisoners or subjects who are involuntarily incarcerated, or subjects who are compulsorily detained for treatment of either a psychiatric or physical illness

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Energy Drink

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.

How Is the Trial Designed?

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 European Union, United States, Canada, Japan, China, Switzerland for the following indications:

Approved in European Union as Energy Drink for:

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

Approved in United States as Energy Drink for:

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

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

Who Is Running the Clinical Trial?

University of Florida

Lead Sponsor

Trials

1,428

Recruited

987,000+

McJunkin Family Charitable Foundation

Collaborator

Trials

1

Recruited

60+

Published Research Related to This Trial

The developed isotonic beverage from natural apple concentrate effectively replenishes key electrolytes lost through sweat, such as sodium, potassium, and magnesium, making it suitable for athletes.

The beverage was optimized for taste and quality, achieving a shelf life of at least 3 months when stored at refrigeration temperatures, while providing 30% of the Recommended Daily Allowance of essential vitamins for physical activity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Development and optimization of an isotonic sports drink]. López, L., Wittig de Penna, E., Bunger, A., et al.[2016]

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]

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]

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]

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]

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]

To optimize recovery after endurance and team sports, athletes should consume about 1.2 g of carbohydrates per kilogram of body weight immediately after exercise and every hour for 4-6 hours, or 0.8 g of carbohydrates combined with 0.4 g of protein per hour.

Recovery beverages should also include electrolytes, particularly sodium, to aid rehydration, and recent studies suggest that chocolate milk may be as effective, or even superior, to commercial recovery drinks in promoting recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Building a beverage for recovery from endurance activity: a review. Spaccarotella, KJ., Andzel, WD.[2016]

Certain sports and energy drinks, specifically Gatorade Protein Recovery Shake and Starbucks Doubleshot Espresso Energy, significantly increased the formation and metabolic activity of Streptococcus mutans biofilm, indicating a potential risk for dental cavities.

In contrast, most other drinks tested inhibited biofilm growth and metabolic activity, suggesting that not all sports and energy drinks have the same cariogenic potential.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

In Vitro Effects of Sports and Energy Drinks on Streptococcus mutans Biofilm Formation and Metabolic Activity. Vinson, LA., Goodlett, AK., Huang, R., et al.[2018]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9105126/

Effects of Energy Drink Acute Assumption in Gastrointestinal ... We found that, while EDs did not cause any evident acute lesion to the GI tract, they triggered eosinophilic infiltration in the intestinal ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3127503/

Energy-balance studies reveal associations between gut ... Studies in mice indicate that the gut microbiome influences both sides of the energy-balance equation by contributing to nutrient absorption and regulating ...

3. foxcarolina.com foxcarolina.com/video/2025/02/20/how-energy-drinks-can-impact-your-gut-microbiome/

How energy drinks can impact your gut microbiome A new study shows energy drinks can impact your gut microbiome and even create an environment that makes you more susceptible to colal cancer.

4. sciencedirect.com sciencedirect.com/science/article/pii/S2161831322005002

Fueling Gut Microbes: A Review of the Interaction between ... There is limited evidence on the effect of hydration status or sports drinks on the gut microbiota, although dehydration is associated with constipation and ...

5. foodguides.com foodguides.com/blogs/from-the-experts/gut-instincts-investigating-the-impact-of-energy-drinks-on-digestion

Gut Instincts: Investigating the Impact of Energy Drinks on ... Specifically, these changes in the microbiota were linked to poorer metabolic health and the development of obesity. Navigating Sugar ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4682602/

Energy Drink Consumption: Beneficial and Adverse Health ... In addition, the high sugar content in energy drinks may reduce the activity, diversity and gene expression of intestinal bacteria resulting in increased risk ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10144565/

Effect of Non-Nutritive Sweeteners on the Gut Microbiota The diet has a marked effect, impacting the gut microbiota composition, beneficially or detrimentally, by altering some bacterial species and adjusting the ...

8. cancer.gov cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2024-02154

Evaluating the Effects of Energy Drink Consumption on ... This clinical trial evaluates how energy drink consumption alters the microorganisms (microbiome) found in the colon in health individuals.

9. mdpi.com mdpi.com/2072-6643/14/9/1928

Effects of Energy Drink Acute Assumption in ... Our data suggest that caffeine present in ED can cause a local, transient inflammatory status that recruits eosinophils.