76 Participants Needed

Energy Drinks and Gut Bacteria Changes

(ROSANNA Trial)

JW
Overseen ByJudy Walsh
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 6 JurisdictionsThis treatment is already approved in other countries

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.12345

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.56789

Research Team

Clinical Oncology Β» Cancer Center ...

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.
See 5 more

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
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
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.

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

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Approved in European Union as Energy Drink for:
  • General Health and Wellness
  • Physical Performance Enhancement
  • Mental Alertness
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Approved in United States as Energy Drink for:
  • General Health and Wellness
  • Physical Performance Enhancement
  • Mental Alertness
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Approved in Canada as Energy Drink for:
  • General Health and Wellness
  • Physical Performance Enhancement
  • Mental Alertness
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Approved in Japan as Energy Drink for:
  • General Health and Wellness
  • Physical Performance Enhancement
  • Mental Alertness
πŸ‡¨πŸ‡³
Approved in China as Energy Drink for:
  • General Health and Wellness
  • Physical Performance Enhancement
  • Mental Alertness
πŸ‡¨πŸ‡­
Approved in Switzerland as Energy Drink for:
  • General Health and Wellness
  • Physical Performance Enhancement
  • Mental Alertness

Find a Clinic Near You

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+

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.
Supplementary effect of carbohydrate-electrolyte drink on sports performance, lactate removal & cardiovascular response of athletes.Khanna, GL., Manna, I.[2013]
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.
Building a beverage for recovery from endurance activity: a review.Spaccarotella, KJ., Andzel, WD.[2016]
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.
[Dehydration and rehydration of the human body. Physiopathologic and clinical considerations].Formenti, A., Vittadini, G.[2006]

References

Supplementary effect of carbohydrate-electrolyte drink on sports performance, lactate removal & cardiovascular response of athletes. [2013]
Building a beverage for recovery from endurance activity: a review. [2016]
[Dehydration and rehydration of the human body. Physiopathologic and clinical considerations]. [2006]
Risk of Energy Drink Consumption to Adolescent Health. [2023]
In Vitro Effects of Sports and Energy Drinks on Streptococcus mutans Biofilm Formation and Metabolic Activity. [2018]
[Risks of energy drinks in youths]. [2022]
[The history, ingredients and effects of energy drinks]. [2021]
[Development and optimization of an isotonic sports drink]. [2016]
Knowledge and Behavior of Saudi College Athletes toward Energy and Sports Drinks with an Emphasis on Microbial Quality and Safety. [2023]
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