Caffeinated Sports Drink for Exercise Performance

(NRG Trial)

Recruiting in Palo Alto (17 mi)

Overseen by Stavros Kavouras, PhD

Age: 18 - 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Arizona State University

Must not be taking: Testosterone therapy

Disqualifiers: Caffeine sensitivity, Cancer, Pregnancy, others

Approved in 4 Jurisdictions

Trial Summary

What is the purpose of this trial?

Caffeine is known to enhance physical and mental performance, but few beverages combine caffeine with electrolytes and carbohydrates to enhance exercise performance. This study evaluates a caffeinated electrolyte-glucose drink's effect on endurance, strength, and cognition. Using a repeated-measures, cross-over design, 20 trained cyclists will complete one familiarization and four randomized 3-hour experimental trials (Liquid I.V.™ Energy Multiplier, Hydration Multiplier, Sugar-Free Hydration Multiplier, and water). Each trial includes 2 hours of cycling in a warm environment (32ºC), followed by strength and cognitive assessments. Cycling performance, capillary blood, urine, and expiratory gases will be collected.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you are using testosterone therapy, you cannot participate in the trial.

What data supports the effectiveness of the treatment Caffeinated Sports Drink for Exercise Performance?

Research shows that carbohydrate-electrolyte drinks can improve sports performance and energy balance during exercise. Additionally, caffeine in these drinks has been found to enhance cognitive functions and improve performance in endurance activities. ^{1 2 3 4 5}

Is a caffeinated sports drink safe for humans during exercise?

Research shows that caffeinated sports drinks do not impair hydration and maintain cardiovascular and body temperature regulation during exercise in warm, humid conditions. Additionally, caffeine levels in urine after consuming these drinks during exercise are below the doping limits set by the International Olympic Committee, indicating safety in terms of caffeine intake. ^{1 2 6 7 8}

How does the caffeinated sports drink treatment differ from other treatments for exercise performance?

The caffeinated sports drink is unique because it combines caffeine with carbohydrates and electrolytes, which not only helps maintain energy balance during exercise but also improves cognitive functions and physical performance, such as sprinting and jumping, compared to non-caffeinated options. ^{1 2 5 7 9}

Research Team

Stavros Kavouras, PhD

Principal Investigator

Arizona State University

Eligibility Criteria

This trial is for trained cyclists who can handle a tough workout in the heat. They'll be testing different drinks, including one with caffeine and sugar, another without sugar, and plain water. People with health issues that make exercise risky or those on medications affecting hydration or energy levels can't join.

Inclusion Criteria

I have been healthy and free from muscle or bone injuries for over 2 months.

Active cyclists who train at least 3 times per week

Body mass index (BMI) range of 18.5-30 kg/m2

Exclusion Criteria

I am unable to make my own medical decisions.

Pregnancy

History of a heat stroke

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Familiarization

Participants complete a familiarization trial without any blood sampling

1 session

1 visit (in-person)

Experimental Trials

Participants complete four randomized 3-hour experimental trials with different beverages, including cycling, strength, and cognitive assessments

4 sessions

4 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the experimental trials

2 weeks

Treatment Details

Interventions

• Caffeinated Carbohydrate and electrolyte drink (Caffeine Drink)

Trial Overview Researchers are looking at how a caffeinated sports drink compares to other drinks in improving cycling performance, strength, and brain function during intense exercise. Participants will cycle for hours in warm conditions and then do physical and mental tests.

Participant Groups

Group I: no-sugar electrolyte solution Experimental Treatment 1 Intervention

1% carbohydrate solution with 1,060 mg/L of Sodium

Group II: Carbohydrate electrolyte solution Experimental Treatment 1 Intervention

2% carbohydrate solution with 1,020 mg/L of Sodium

Group III: Caffeinated carbohydrate electrolyte solution Experimental Treatment 1 Intervention

1% carbohydrate solution with 1,000 mg/L of Sodium, and 200mg/L Caffeine

Group IV: Water Placebo Group 1 Intervention

Water masked with non-caloric and no-sodium

Caffeinated Carbohydrate and electrolyte drink is already approved in Canada for the following indications:

Approved in Canada as Caffeinated Sports Drinks for:

• Exercise Performance Enhancement
• Hydration

Who Is Running the Clinical Trial?

Arizona State University

Lead Sponsor

Trials

311

Recruited

109,000+

Mark McKenna

Arizona State University

Chief Executive Officer

Bachelor’s degree in marketing from Arizona State University, MBA from Azusa Pacific University

Cedric O’Gorman

Arizona State University

Chief Medical Officer since 2023

MD from Harvard Medical School

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]

In a study involving 15 endurance-trained male athletes, carbohydrate electrolyte solutions (CES) with low doses of caffeine improved long-term memory before exercise compared to placebo drinks.

After exercise, CES drinks with low and medium doses of caffeine enhanced cognitive functions such as attention, psychomotor skills, and memory, demonstrating that even small amounts of caffeine can positively affect cognitive performance following strenuous physical activity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Caffeine improves cognitive performance after strenuous physical exercise. Hogervorst, E., Riedel, WJ., Kovacs, E., et al.[2022]

In a study involving 22 professional male soccer players, consuming a carbohydrate-electrolyte drink during a 90-minute match resulted in higher blood glucose levels and improved performance in specific soccer skills compared to a placebo.

Players who ingested the carbohydrate-electrolyte drink completed a dribble test faster and had better precision scores, indicating that this type of drink can enhance skill performance and recovery during soccer matches.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of a carbohydrate-electrolyte drink on specific soccer tests and performance. Ostojic, SM., Mazic, S.[2021]

A study involving 16 cyclists found that a caffeinated sports drink did not impair hydration or fluid delivery during exercise in warm, humid conditions, maintaining similar hydration levels as a carbohydrate-electrolyte drink.

Despite higher serum osmolality with the caffeinated drink compared to placebo, it still supported cardiovascular and thermoregulatory functions effectively, indicating that caffeine does not negatively affect hydration during exercise.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hydration during exercise in warm, humid conditions: effect of a caffeinated sports drink. Millard-Stafford, ML., Cureton, KJ., Wingo, JE., et al.[2019]

In a study involving 50 adult triathletes and runners, a commercially available 6% carbohydrate-electrolyte sports beverage (CCE) was found to be the most palatable and consumed the most during exercise compared to diluted orange juice (DOJ), homemade sports beverage (HCE), and water (W).

The results suggest that beverage palatability significantly influences voluntary intake during exercise, with CCE being preferred over other options, which could impact hydration and energy replenishment strategies for athletes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Palatability and voluntary intake of sports beverages, diluted orange juice, and water during exercise. Passe, DH., Horn, M., Stofan, J., et al.[2019]

In a study with 58 well-trained male cyclists, consuming a carbohydrate-electrolyte solution with 150 mg/L caffeine during 4 hours of cycling resulted in post-exercise urinary caffeine levels that were below the International Olympic Committee's doping threshold.

There was a strong positive correlation between caffeine intake and post-exercise urinary caffeine concentration, indicating that the amount of caffeine consumed directly affects its concentration in urine.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of ad libitum ingestion of a caffeinated carbohydrate-electrolyte solution on urinary caffeine concentration after 4 hours of endurance exercise. Kovacs, EM., Martin, AM., Brouns, F.[2013]

In a study involving 15 male soccer players, adding caffeine to a carbohydrate-electrolyte solution improved sprinting performance and explosive leg power during prolonged soccer activity, with faster sprint times and higher jump heights observed with caffeine ingestion.

Participants reported enhanced subjective experiences and pleasure during the caffeine trial, suggesting that caffeine not only boosts physical performance but also positively affects athletes' mental states during exercise.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The influence of caffeine and carbohydrate coingestion on simulated soccer performance. Gant, N., Ali, A., Foskett, A.[2022]

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. Germany pubmed.ncbi.nlm.nih.gov

Caffeine improves cognitive performance after strenuous physical exercise. [2022]

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

Sports drinks: research asks for reevaluation of current recommendations. [2019]

4. Canada pubmed.ncbi.nlm.nih.gov

Low and moderate doses of caffeine late in exercise improve performance in trained cyclists. [2017]

5. Turkey pubmed.ncbi.nlm.nih.gov

Effects of a carbohydrate-electrolyte drink on specific soccer tests and performance. [2021]

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

Hydration during exercise in warm, humid conditions: effect of a caffeinated sports drink. [2019]

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

Palatability and voluntary intake of sports beverages, diluted orange juice, and water during exercise. [2019]

8. Germany pubmed.ncbi.nlm.nih.gov

The effect of ad libitum ingestion of a caffeinated carbohydrate-electrolyte solution on urinary caffeine concentration after 4 hours of endurance exercise. [2013]

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

The influence of caffeine and carbohydrate coingestion on simulated soccer performance. [2022]