Clinical trial NCT07024940: Short-term Effects of Caffeine and a Multi-ingredient Pre-workout on Exercise Performance
Official title: Acute Effects of Coffee, Anthocyanin-Caffeine Supplement and Placebo on Exercise Performance Markers
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Coffee
Anthocyanins
Exercise Performance
Exercise Testing
Keywords: Coffee
Caffeine
Wingate
Anthocyanin-Caffeine
1-mile
VO2 max
pre-workout
supplement
Lead sponsor: St. Louis University
Sponsor class: OTHER
First posted: 2025-06-17
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: The investigators are conducting a study to see how a commercial pre-workout supplement, coffee, and water affect how well people perform. The study is conducted across four visits. The first visit is to assess the participants, and the next three visits are for testing. Each participant will drink a randomly assigned beverage 45 minutes before testing. Throughout the study, the participants will complete three testing days-each at least three days apart-so they can try all three drinks. The first test is the Wingate test, where the participants pedal as fast as they can for 30 seconds against a set resistance. The second test is a 1-mile treadmill run/walk on an incline, where the participant tries to complete the distance as fast as possible. The third test measures reaction time using light-up buttons to see how quickly a participant responds by touching them. These tests will help determine if any of the drinks improve performance. The results can help people choose the best drink for their workouts or races.

Detailed description: This study is being conducted to evaluate how a commercial pre-workout supplement with multiple ingredients and coffee affects how people perform during exercise testing. The study takes place over 4 separate lab visits. The first lab visit is an assessment for each participant to help define the population to be tested. Then, three testing visits will be identical in design but will differ in the intervention given to the participant. Each participant will consume the pre-workout, coffee, and a placebo in a randomized order. At the beginning of each visit, the participant will consume their assigned beverage. The participants will then start a warm-up after 30 minutes of consuming the assigned beverage. After the 10-minute warm-up, the participant will rest for five minutes before conducting the testing. In the testing visits, participants will conduct a 1-mile treadmill run, in which the participant will determine their speed using a 1% incline. This allows the participant to control the speed, allowing them to try as hard as they can. The next test will be a Wingate cycle ergometer test. The test contains a 20-second warm-up up then a three-second period where the participant will pedal as fast as they can until the test begins, then they will do an all-out effort for 30 seconds. The participant will then conduct an agility reaction time test to measure any benefits the interventions may have on cognitive function.

Eligibility criteria: Inclusion Criteria:

* Are a healthy male or female adult aged 18-35 years old
* Regularly engaged in resistance training or aerobic exercise at least 3 times per week, at least 30 minutes a week for the past 6 months
* Able to provide written informed consent

Exclusion Criteria:

* Have a history of or currently have a cardiovascular or metabolic disease (e.g., diabetes, prediabetes, hypertension, arrhythmia, heart attack, stroke, non-alcoholic fatty liver disease, chronic kidney disease)
* History of seizure disorder
* Currently taking prescription medications (e.g., beta-blockers, antidepressants, anti-anxiety, pain killers)
* Currently pregnant, breastfeeding, pregnant within the past year, or change of being pregnant
* Recent participation in another clinical trial
* Any sensitivities to caffeine, coffee, berries, malodextrin, monk fruit extract, or any known food allergies
* Currently undertaking serious exercise training (6 or more days of the week)
* Recently started taking creatine or beta-alanine daily within the past 3 months. (If greater than 3 months taken consistently is okay)

Primary outcomes:
measure: Change in anaerobic power measured by a 30-second all-out effort on a cycle ergometer
timeFrame: At 45 minutes post-dose for each intervention condition
Secondary outcomes:
measure: 1-mile Treadmill time trial
timeFrame: At 45 minutes post-dose for each intervention condition
measure: Agility Reaction Time
timeFrame: At 45 minutes post-dose for each intervention condition
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Saint Louis University
state: Missouri
Study officials:
affiliation: St. Louis University
name: Hossein Rafiei, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Castañeda-Babarro A. The Wingate Anaerobic Test, a Narrative Review of the Protocol Variables That Affect the Results Obtained. Applied Sciences. 2021; 11(16):7417. https://doi.org/10.3390/app11167417
citation: Lindsey ZR, Williams JR, Burgess JS, Moore NT, Splichal PM. Caffeine content in filter coffee brews as a function of degree of roast and extraction yield. Sci Rep. 2024 Nov 25;14(1):29126. doi: 10.1038/s41598-024-80385-3.
citation: Jardine WT, Aisbett B, Kelly MK, Burke LM, Ross ML, Condo D, Periard JD, Carr AJ. The Effect of Pre-Exercise Hyperhydration on Exercise Performance, Physiological Outcomes and Gastrointestinal Symptoms: A Systematic Review. Sports Med. 2023 Nov;53(11):2111-2134. doi: 10.1007/s40279-023-01885-2. Epub 2023 Jul 25.
citation: Peacock OJ, Thompson D, Stokes KA. Voluntary drinking behaviour, fluid balance and psychological affect when ingesting water or a carbohydrate-electrolyte solution during exercise. Appetite. 2012 Feb;58(1):56-63. doi: 10.1016/j.appet.2011.08.023. Epub 2011 Sep 29.
citation: Lee JD, Sterrett LE, Guth LM, Konopka AR, Mahon AD. The effect of pre-exercise carbohydrate supplementation on anaerobic exercise performance in adolescent males. Pediatr Exerc Sci. 2011 Aug;23(3):344-54. doi: 10.1123/pes.23.3.344.
citation: Kaczka P, Batra A, Kubicka K, Maciejczyk M, Rzeszutko-Belzowska A, Pezdan-Sliz I, Michalowska-Sawczyn M, Przydzial M, Plonka A, Cieszczyk P, Huminska-Lisowska K, Zajac T. Effects of Pre-Workout Multi-Ingredient Supplement on Anaerobic Performance: Randomized Double-Blind Crossover Study. Int J Environ Res Public Health. 2020 Nov 9;17(21):8262. doi: 10.3390/ijerph17218262.
citation: Krzysztof, Wioleta Dorobek, Katarzyna Stankiewicz, Janusz Świeczkowski-Feiz. The Role of Caffeine in Enhancing Physical Performance: From Metabolism to Muscle Function. Journal of Education, Health and Sport. 2024;59. doi:10.12775/JEHS.2024.59.010