Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06321861
Other study ID # Caffeine_motivation
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date January 19, 2024
Est. completion date May 1, 2024

Study information

Verified date March 2024
Source Jagiellonian University
Contact Ewa Szumowska
Phone +48504756394
Email ewa.szumowska@uj.edu.pl
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The main objective of the study is to evaluate the influence of caffeine intake on participants' energetic arousal, affect, motivation to achieve a training goal, satisfaction with training, and the sense of agency during training. Consequently, participants will engage in three sessions: caffeine, placebo, and no substance (in counterbalanced order). During each session, their affective and motivational states will be assessed, along with the performance of a standardized physical exercise test. The investigators hypothesize that participants who consume caffeine (caffeine condition) will exhibit higher levels of energy and motivation compared to the other two groups. Additionally, they are expected to experience greater optimism and expectancy regarding their training goals and achieve better results in the physical exercise test. A secondary aim of the study is to examine the impact of genetic variability on motivational and affective states of participants, as well as their performance in the physical exercise test after caffeine. The investigators will assess the CYP1A2 (-163C > A, rs762551; characterized such as "fast" (AA genotype) and "slow" caffeine metabolizers (C-carriers)) and ADORA2A (1976T > C; rs5751876; characterized by "high" (TT genotype) or "low" sensitivity to caffeine (C-carriers)).


Description:

Before participating in the study, participants will answer questions regarding their consumption of caffeinated beverages and the frequency of their workouts. They will also complete the Extreme Personality Scale measuring the tendency to pursue goals single-mindedly. Subsequently, they will be qualified for the study based on the questionnaire results and a brief interview. The study will involve the manipulation of energization through the administration of caffeine. Participants will take part in a randomized, crossover, double-blind study, where they will perform three identical training sessions after consuming: a) caffeine at a dose of 3 mg/kg of body weight; b) a placebo; and c) under control conditions (i.e., without substance administration). Capsule consumption will occur 60 minutes before the start of the training. Caffeine and placebo capsules will not differ in size, shape, color, and taste. As the effectiveness of caffeine use depends on the CYP1A2 (rs762551) and ADORA2 (rs5751876) gene polymorphisms, the study will also genotype these genes. The first gene is responsible for the rate of caffeine metabolism, determining whether people metabolize caffeine "fast" or "slow." The ADORA2A gene, encoding the adenosine A2A receptor, influences how "sensitive" people are to caffeine. DNA isolates obtained from oral epithelial cells collected from participants by qualified medical personnel will constitute the research material. Oral epithelial swabs will be collected directly from the participants into sterile tubes. Before and after substance intake (and additionally after the exercise test) participants will assess their arousal using the University of Wales Institute of Science and Technology Mood Adjective Checklist. Additionally, after substance intake and before exercise, participants will answer questions about motivation, affect and expectancy regarding training. Subsequently, participants will undergo training, taking the form of a supervised standardized exercise test. After exercise, participants will assess their satisfaction and feelings after completing the training.


Recruitment information / eligibility

Status Recruiting
Enrollment 40
Est. completion date May 1, 2024
Est. primary completion date May 1, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 30 Years
Eligibility Inclusion Criteria: - Age 18-30 years - Caffeine consumption - Engagement in physical activity. Exclusion Criteria: - Diagnosed cardiovascular, metabolic, gastrointestinal, or neurological diseases - Taking medications or supplements that may affect test results - Tobacco smoking - Pregnancy - Potential allergy to caffeine. Participation in the study will be preceded by completing a health questionnaire and providing written consent. Additionally, exclusion from the study will occur upon the explicit request of the participant.

Study Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
Caffeine
Participants will take one caffeine pill. The dose of caffeine will be calculated based on participants' body mass (3mg/kg body mass). Caffeine will be provided in capsules containing the individual amount of caffeine and will be administered orally 60 min before the onset of the exercise protocol.
Placebo
Participants will take one pill with no caffeine in it. The manufacturer of the caffeine capsules will also prepare identical placebo capsules filled out with a microcrystalline cellulose. Placebo will be administered orally 60 min before the onset of the exercise protocol.
Other:
No substance
Participants will take no substance. They will just wait 60 minutes and then engage in the exercise protocol.

Locations

Country Name City State
Poland The Jerzy Kukuczka Academy of Physical Education in Katowice Katowice

Sponsors (3)

Lead Sponsor Collaborator
Jagiellonian University The Jerzy Kukuczka Academy of Physical Education in Katowice, University School of Physical Education, Krakow, Poland

Country where clinical trial is conducted

Poland, 

References & Publications (2)

Matthews G; Jones DM, Chamberlain AG. Refining the measurement of mood: The UWIST mood adjective checklist. British Journal of Psychology, 1990, 81(1): 17-42.

Szumowska E, Molinario E, Jasko K, Hudiyana J, Firdiani NF, Penrod J, Jaume LC, Leander NP, Kreienkamp J, Agostini M, Gruszka A, Szumska I, Stelmaszynska D, Gola M, Altungy P, Gómez Á, Cacek J, & Kruglanski AW (2023). The Extreme Personality: Individual Differences in Proneness to Motivational Imbalance. Manuscript submitted for publication.

Outcome

Type Measure Description Time frame Safety issue
Primary Energetic arousal pre-test Self-reported energetic arousal contrasting vigour with fatigue, measured with the energetic arousal sub-scale of the University of Wales Institute of Science and Technology Mood Adjective Checklist. The values range from 1-4; higher scores indicate greater energetic arousal. Right before the intervention
Primary Energetic arousal post-test Self-reported energetic arousal measured with the energetic arousal sub-scale of the University of Wales Institute of Science and Technology Mood Adjective Checklist. The values range from 1-4; higher scores indicate greater energetic arousal. The change relative to the pre-test will be analyzed. 60 minutes after taking the capsule (waiting in the no-intervention condition); before training
Primary Optimism Situational optimism (expectancy of positive outcomes) measured with 4 items were participants rate the extent to which they: 1) are positively oriented. 2) are full of optimism. 3) can achieve what I set out to do. 4) are capable of a lot. Responses are given on a 1-7 Likert scale. Higher scores indicate greater optimism. The mean of these items will be computed and the change relative to the pre-test will be analyzed. 60 minutes after taking the capsule (waiting in the no-intervention condition); before training
Primary Motivation Motivation to accomplish one's training goals measured with a question where participants rate the extent to which they are motivated to achieve the best result in: 1) one-repetition maximum bench press test, 2) bar velocity in the bench press test, 3) strength-endurance test, 4) countermovement jump. Participants respond to each item on a 1-7 Likert scale. Higher scores indicate greater motivation. 60 minutes after taking the capsule (waiting in the no-intervention condition); before training
Primary Determination Determination to accomplish one's training goals measured with 4 items: 1) During training, everything else will become irrelevant for [the participant[. 2) [The participant] will put a lot of energy into the training. 3) [The participant] will do everything in their power to achieve the training goal. 4) [The participant] will reach the training goal even if it requires a great effort. 5) [The participant] will train despite fatigue. Participants respond to each item on a 1-7 Likert scale. Higher scores indicate greater determination. 60 minutes after taking the capsule (waiting in the no-intervention condition); before training
Primary Relative outcome expectancy Expectancy of the training results measured with a question: In relation to participants' typical result, what result do they expect in: 1) one-repetition maximum bench press test, 2) bar velocity in the bench press test, 3) strength-endurance test, 4) countermovement jump. Participants respond to each item on a 1-7 scale anchored 1 = definitely worse than usual and 7 = definitely better than usual. Higher scores indicate more positive outcome expectations. 60 minutes after taking the capsule (waiting in the no-intervention condition); before training
Primary Success probability Subjective probability of attaining the best result measured with a question: How likely do participants think it is that they will achieve the best result in: 1) one-repetition maximum bench press test, 2) bar velocity in the bench press test, 3) strength-endurance test, 4) countermovement jump. Participants respond to each item on a 1-7 scale anchored 1 = completely unlikely and 7 = certain. Higher scores indicate greater probability of success. 60 minutes after taking the capsule (waiting in the no-intervention condition); before training
Primary Prospective effort Participants' willingness to invest effort in the training measured with a question: How much effort are participants planning to invest in: 1) one-repetition maximum bench press test, 2) bar velocity in the bench press test, 3) strength-endurance test, 4) countermovement jump. Participants respond on a 0-100% scale. Higher scores indicate greater willingness to invest effort. 60 minutes after taking the capsule (waiting in the no-intervention condition); before training
Primary Agency Sense of agency measured with two questions: 1) Do participants feel in control over the outcome in..., 2) Do participants feel in control over their performance in... Participants respond to each question in relation to each test outcome: 1) one-repetition maximum bench press test, 2) bar velocity in the bench press test, 3) strength-endurance test, 4) countermovement jump. Responses are given on 1-6 scale anchored 1 = no control and 7 = complete control. Higher scores indicate greater sense of agency. 60 minutes after taking the capsule (waiting in the no-intervention condition); before training
Primary Performance in the 1RM test Participants' performance in the one-repetition maximum test in bench press [number of kg] 60 minutes after taking the capsule (waiting in the no-intervention condition)
Primary Performance in the bar velocity in the bench press test Participants' performance in the bar velocity during 3 sets of 3 repetitions in the bench press exercise [m/s] 60 minutes after taking the capsule (waiting in the no-intervention condition)
Primary Performance in the strength-endurance test Participants' performance in the strength-endurance test in bench press test (number of repetitions) 60 minutes after taking the capsule (waiting in the no-intervention condition)
Primary Performance in the countermovement jump test Participants' performance in the countermovement jump test (number of cm) 60 minutes after taking the capsule (waiting in the no-intervention condition)
Primary Satisfaction with the results Participants' satisfaction with their training results measured with a question: How satisfied are participants with their results in: 1) one-repetition maximum bench press test, 2) bar velocity in the bench press test, 3) strength-endurance test, 4) countermovement jump. Participants respond to each item on a 1-7 scale anchored 1 = definitely unsatisfied to 7 = definitely satisfied. Higher scores indicate greater satisfaction with the results. Immediately after the physical exercise test
Primary Retrospective effort Participants' assessment of effort invested in the training measured with a question: How much effort did participants invest in:1) one-repetition maximum bench press test, 2) bar velocity in the bench press test, 3) strength-endurance test, 4) countermovement jump. Participants respond on a 0-100% scale. Higher scores indicate greater effort. Immediately after the physical exercise test
Primary Retrospective agency Sense of agency measured with two questions: 1) Did participants feel in control over the outcome in..., 2) Did participants feel in control over their performance in... Participants respond to each question in relation to each test outcome: 1) one-repetition maximum bench press test, 2) bar velocity in the bench press test, 3) strength-endurance test, 4) countermovement jump. Responses are given on 1-6 scale anchored 1 = no control and 7 = complete control. Higher scores indicate greater sense of agency. Immediately after the physical exercise test
Secondary Goal importance Importance of the training goal measured with a question: How important is it for participants to achieve the best possible result in: 1) one-repetition maximum bench press test, 2) bar velocity in the bench press test, 3) strength-endurance test, 4) countermovement jump. Participants respond to each item on a 1-7 scale anchored 1 = completely unimportant and 7 = extremely important. Higher scores indicate greater importance. 60 minutes after taking the capsule (waiting in the no-intervention condition); before training
Secondary Prospective difficulty Perceived difficulty of the training goal measured with a question: How do participants assess the difficulty of: 1) one-repetition maximum bench press test, 2) bar velocity in the bench press test, 3) strength-endurance test, 4) countermovement jump. Participants respond to each item on a 1-7 scale anchored 1 = definitely easy and 7 = definitely difficult. Higher scores indicate greater subjective difficulty. 60 minutes after taking the capsule (waiting in the no-intervention condition); before training
Secondary Expected performance in the 1RM test Participants' expected performance in the 1 RM test. Participants provide responses to the following questions:
How much weight do participants think they will lift in the 1 RM test? (participants provide in kg)
60 minutes after taking the capsule (waiting in the no-intervention condition); before training
Secondary Expected performance in the bar velocity in the bench press test Participants' expected performance in the bar velocity in the bench press test. Participants provide a response to the following question:
How much m/s. do participants expect to achieve in the bar velocity test? (participants provide the response in m/s)
60 minutes after taking the capsule (waiting in the no-intervention condition); before training
Secondary Expected performance in the strength-endurance test Participants' expected performance in the strength-endurance test. Participants provide a response to the following question:
How many repetitions do participants think they will perform in the strength-endurance test? (participants provide the number of repetitions)
60 minutes after taking the capsule (waiting in the no-intervention condition); before training
Secondary Expected performance in the countermovement jump test Participants' expected performance in the countermovement jump test. Participants provide a response to the following question:
How high do participants think they will jump? (participants provide in cm)
60 minutes after taking the capsule (waiting in the no-intervention condition); before training
Secondary Retrospective difficulty Assessed difficulty of each training element: 1) one-repetition maximum bench press test, 2) bar velocity in the bench press test, 3) strength-endurance test, 4) countermovement jump. Participants rate each element twice (generally and in relation to their other trainings) on a 1-7 scale anchored 1 = very easy and 7 = very difficult. Higher scores indicate greater difficulty. Immediately after the physical exercise test
Secondary Energetic arousal post-training Self-reported energetic arousal measured with the energetic arousal sub-scale of the University of Wales Institute of Science and Technology Mood Adjective Checklist. The values range from 1-4; higher scores indicate greater energetic arousal. Immediately after the physical exercise test
Secondary Perceived effect on agency Assessed effect on the sense of agency measured with an item:
To what extent do participants agree with the statement: Completing this workout made participants feel like they had control. Participants respond on 1-7 Likert scale. Higher scores indicate the greater perceived effect on agency.
Immediately after the physical exercise test
Secondary Tense arousal Self-reported tense arousal contrasting tension with relaxation, measured with the Tense Arousal subscale of the University of Wales Institute of Science and Technology Mood Adjective Checklist. The values range from 1-4; higher scores indicate greater energetic arousal. Right before the intervention, then 60 minutes after taking the capsule (waiting in the no-intervention condition); and immediately after the physical exercise test
Secondary Hedonic tone Self-reported hedonic tone contrasting pleasant with unpleasant moods, measured with the Hedonic Tone subscale of the University of Wales Institute of Science and Technology Mood Adjective Checklist. The values range from 1-4; higher scores indicate greater energetic arousal. Right before the intervention, then 60 minutes after taking the capsule (waiting in the no-intervention condition); and immediately after the physical exercise test
See also
  Status Clinical Trial Phase
Completed NCT06038903 - The Turkish Version Of The Brief-Caffeine Expectancy Questionnaire
Completed NCT02900261 - Study on Sodium and Caffeine in Children and Adolescents
Completed NCT03850275 - The Effects of e+Shots Energy Beverage on Mental Energy N/A
Completed NCT01924481 - Effects of a Cocoa Shot on the Human Brain N/A
Completed NCT01330680 - Genetic Determinants of Cardiovascular Response to Coffee Drinking N/A
Completed NCT00184912 - The Effect of Caffeine on Ischemic Preconditioning N/A
Completed NCT03859882 - Protocol PERCAF 2018 N/A
Completed NCT02832401 - The Impact of Caffeine on Cognition in Schizophrenia N/A
Completed NCT04560595 - Remote Guided Caffeine Reduction N/A
Recruiting NCT05503732 - Effects of Energy Drinks on Sleep and Cardiovascular Health N/A
Not yet recruiting NCT05521386 - The Effects of Caffeine on Heart Rate and Heart Rate Variability N/A
Completed NCT06039358 - Effects of Caffeine Ingestion on the Biomechanics of Healthy Young Subjects N/A
Active, not recruiting NCT04547868 - Can Coffee/Caffeine Improve Post-Operative Gastrointestinal Recovery N/A
Completed NCT05559372 - Energy Drink Effects on Performance, Mood, and Cardiovascular Outcomes N/A
Completed NCT01783561 - Early Versus Routine Caffeine Administration in Extremely Preterm Neonates Phase 4
Completed NCT04852315 - Acute Caffeine Ingestion on Futsal Performance N/A
Completed NCT05975489 - Genetics in the Effect of Caffeine on Fat Oxidation N/A
Recruiting NCT03298347 - Caffeine for Preterm Infants With Apnea of Prematurity(AOP) N/A
Completed NCT01435486 - Caffeine Citrate for the Treatment of Apnea Associated With Bronchiolitis in Young Infants N/A
Completed NCT04869176 - Effect of Caffeine on Heart Rate Variability in Newborns N/A