- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06721793
The Impact of a Caffeinated Sports Drink on Performance (NRG)
Study Overview
Status
Conditions
Detailed Description
Each subject will complete 5 trials (1 familiarization and 4 experimental) consisting of approximately 2 hours cycling in a warm environment (90ºF), followed by strength assessment and cognitive assessment via questionnaire. Each trial will be identical, with the only difference being the type of drink consumed during each trial. The first trial will be for familiarization without any blood sampling. The rest of the trials will be completed in a randomized order and the drink consumed
Cycling Endurance Exercise Performance
The exercise test will consist of a series of three consecutive cycling sets in a warm environment (90ºF), with each series consisting of:
- a 30-min submaximal ride (50% maximal power as determined from the initial)
- a 5-km time trial race-like performance effort. During each 30 min submaximal rides participants will drink a total 500 mL of fluid spread out during the 30 min. During the 5 km performance test the participants will drink 25 mL of fluid at the end of each kilometer.
At regular intervals throughout the exercise task, body weight, blood samples, respiratory gasses, and perceptual data will be collected. See study schematic provided below for specific measurement timepoints.
Upon completion of the cycling task subjects will moved to another room with cool temperature (70ºF), where strength and cognitive function will be assessed to determine the influence of each beverage on indices of exercise performance and fatigue.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Arizona
-
Phoenix, Arizona, United States, 85004
- Arizona State University - Hydration Science Lab
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age 18-55
- Healthy and injury-free (muscle, skeletal) for greater than 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:
• History of caffeine sensitivity
- Cancer Diagnosis during the last 5 years
- Pregnancy
- History of renal disease, hypertension
- History of a heat stroke
- Use of testosterone therapy
- Adults who are unable to consent (impaired decision-making capacity)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Placebo Comparator: Water
Water masked with non-caloric and no-sodium
|
flavored water with non-caloric, non-sodium-containing sweetner
|
|
Experimental: Carbohydrate electrolyte solution
2% carbohydrate solution with 1,020 mg/L of Sodium
|
2% carbohydrate solution with 1,020 mg/L of Sodium
|
|
Experimental: no-sugar electrolyte solution
1% carbohydrate solution with 1,060 mg/L of Sodium
|
1% carbohydrate solution with 1,060 mg/L of Sodium
|
|
Experimental: Caffeinated carbohydrate electrolyte solution
1% carbohydrate solution with 1,000 mg/L of Sodium, and 200mg/L Caffeine
|
2% carbohydrate solution with 1,000 mg/L of Sodium, and 200mg/L caffeine
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
5 kilometer cycling time trial
Time Frame: During the 3rd time trial which is the last time trial.
|
Time in minutes of completion the 5 kilometer cycling time trial at the 3rd exercise bout.
|
During the 3rd time trial which is the last time trial.
|
|
5 kilometer Time trial performance
Time Frame: 2nd time trial
|
Time to completion the 2nd cycling time trial
|
2nd time trial
|
|
Isokinetic stregth
Time Frame: right after the cycling tests
|
Peak torque at 60º/sec at dominant knee during extension
|
right after the cycling tests
|
|
Congitive performance 1
Time Frame: after the completion of strength test
|
Attention Network Test score
|
after the completion of strength test
|
|
Cognitive performance 2
Time Frame: after the end of the strength assessment
|
Working Memory Test score
|
after the end of the strength assessment
|
|
Congitive test 3
Time Frame: right after the strength test
|
Stroop Task score
|
right after the strength test
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Blood glucose
Time Frame: at the end of the 3rd cycling time trial.
|
Blood glucose levels during the 3rd cycling time trial.
|
at the end of the 3rd cycling time trial.
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Stavros Kavouras, PhD, Arizona State University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- FP00041543
- AWD00039989 (Other Identifier: ASU)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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