Physical ActivityNCT03936712
Effect of Energy Drink on Sport Performance and Psycho-Physiological Responses.
A study testing Energy Drink in people with Physical Activity, run by The Higher Institute of Sport and Physical Education of Sfax.
Trial summary
This work aimed to examine the effects of drinking an "energy drink" upon (i) short-term maximal performance, (ii) reaction times and (iii) psychological factors (i.e., mood state, ratings of perceived exertion (RPE) and affective load) and on physiological parameters such as blood pressure, blood glucose… Read more about this study
- Who is it for?
- Ages 18 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Physical Activity
- What is being tested?
- Energy Drink
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 22 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2017to 12 Jan 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 18-40 years of age,
- BMI less than 25 kg/m2,
- low (<1.5g/month [20]) caffeine users
- not regular caffeine users.
Who cannot join
- chronic metabolic disease such as type 2 diabetes and cardiovascular disease
- auto-immune disease such as rheumatoid arthritis, lupus or type 1 diabetes,
- liver disease
- intake of any medications/ or dietary supplements known to influence blood glucose and/or blood pressures.
About this study
Official title: Effects of Energy Drink on Performance and Psycho-Physiological Response to Physical Exercise
This work aimed to examine the effects of drinking an "energy drink" upon (i) short-term maximal performance, (ii) reaction times and (iii) psychological factors (i.e., mood state, ratings of perceived exertion (RPE) and affective load) and on physiological parameters such as blood pressure, blood glucose, hematological parameters and other biochemical parameters.
Read the detailed description
A total of 22 healthy and regularly active physical-education male students from various sports disciplines volunteered to participate in this study. Potential participants were initially screened through telephone interviews based on the inclusion criteria: 18-40 years of age, BMI less than 25 kg/m2, and low (<1.5g/month ) and not regular caffeine users. Exclusion criteria included diagnosis of any chronic metabolic disease such as type 2 diabetes or cardiovascular disease, an auto-immune disease such as rheumatoid arthritis, lupus or type 1 diabetes, liver disease and the intake of any medications/ or dietary supplements known to influence blood glucose concentrations and/or blood pressures.
The study was conducted according to the declaration of Helsinki and the protocol was fully approved (identification code: 8/16) by the review board "Local committee of the Laboratory of Biochemistry, CHU Habib Bourguiba, Sfax, Tunisia." After a throughout explanation of the protocol and responses to all questions, participants signed a written informed consent.
Subjects were instructed to avoid nicotine, alcohol, dietary supplements, medications and all other stimulants and to maintain their normal dietary, sleep and physical activity patterns before test sessions. Caffeine and other caffeinated products (e.g., chocolate, caffeinated gums, caffeine containing beverages) were avoided for 48 hours and food for at least 4 hours before testing.
A double blind, placebo-controlled, counterbalanced, crossover design was adopted for this study. The randomized order of testing was determined using free online software (www.randomization.com). Neither staff nor participants were informed about the names of the two drinks, and blinding was strictly maintained by emphasizing to both staff and participants that both drinks adhered to healthy principles, and that each was advocated by certain sports medicine experts. Two familiarization sessions were completed before definitive test sessions in order to eliminate any learning effects on physical performance and reaction time measurements. During the second familiarization session, body mass and height were recorded. Each participant visited the laboratory for two formal test sessions, drinking a caffeine-containing ED (RB) and a caffeine and taurine free beverage drink (PL). All sessions were arranged in the early evening hours to avoid any time of day effects. The two definitive test sessions were separated by an interval of seven days to allow sufficient recovery between tests and to ensure caffeine washout. To avoid identification, two opaque and unmarked cans of RB or PL were ingested by each participant (i.e., 500 mL) in the presence of a researcher. The two drinks were similar in volume, texture, and appearance. One can of RB drink (i.e., 250ml) contained 80 mg of caffeine, 1 g of taurine, 27 g of carbohydrates, 0.6 g of protein, 5 mg vitamin B6 and 487 kJ of energy. The PL drink was prepared by an agri-food engineer; it did not contain any caffeine or taurine, but comprised carbonated water, carbohydrates, citric acid lemon juice reconstituted from concentrate (1 %), supplemented by flavorings, of sodium citrate, acesulfame K, sucralose, potassium sorbate and RB (a flavoring that contains propylene glycol E1520 (0.23 mL).
Beverages were prepared, shaken and chilled in a refrigerator at 14h00 by an investigator who took no part in the test sessions or data analysis, but prepared the alphanumeric code identifying the tested drink. At 17h00, the cooled beverages were served in sealed plastic opaque water bottles and consumed using an opaque straw. Participants were instructed to drink the fluid quickly (within 1±0.5 min) 60 minutes before their test session and not to discuss or compare tastes or to make any assumptions about what they had ingested. The interval of 60 minutes was chosen as optimal for a complete caffeine absorption and thus a peaking of a caffeine concentration .
Subjects were supervised by staff to ensure that they drank the entire quantity of fluid, and no exchange of bottles was allowed. The last standardized meal (i.e., lunch) before the beginning of the test session was taken at 13h00. Temperature and relative humidity of the laboratory were similar over the test sessions, with a temperature of around 22°C and a relative humidity between 45 and 55 %. During each test session (from 18h00), resting blood glucose and blood pressures were measured and the participants completed the POMS questionnaire.
A 5-min treadmill warm-up was performed. After that, the reaction time, and handgrip force were determined, and the 30-s Wingate test was performed. RPE scores, blood glucose and blood pressures were then measured, and the affective load was calculated. To investigate the effects of RB on the acute physiological and psychological responses to exercise, blood measures and psychological test measures were collected immediately pre- and post-exercise.
- Conditions
- Physical Activity
- Being tested
- Energy Drink, Placebo Drink
- Keywords
- Energy drinks, Exercise, Physiological response, Mood State, Fatigue
- Medical subject headings
- Motor Activity, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Energy DrinkDietary supplement
Each participant visited the laboratory for two formal test sessions, drinking a caffeine-containing ED (RB) and a caffeine and taurine free beverage drink (PL). All sessions were arranged in the early evening hours to avoid any time of day effects. The two definitive test sessions were separated by an interval of seven days to allow sufficient recovery between tests and to ensure caffeine washout. To avoid identification, two opaque and unmarked cans of RB or PL were ingested by each participant (i.e., 500 mL) in the presence of a researcher. The two drinks were similar in volume, texture, and appearance. One can of RB drink (i.e., 250ml) contained 80 mg of caffeine, 1 g of taurine, 27 g of carbohydrates, 0.6 g of protein, 5 mg vitamin B6 and 487 kJ of energy.
Placebo DrinkDietary supplement
The PL drink was prepared by an agri-food engineer; it did not contain any caffeine or taurine, but comprised carbonated water, carbohydrates, citric acid lemon juice reconstituted from concentrate (1 %), supplemented by flavorings, of sodium citrate, acesulfame K, sucralose, potassium sorbate and RB (a flavoring that contains propylene glycol E1520 (0.23 mL).
| Study group | Role | What they receive |
|---|---|---|
| Red Bull drink (RB) | Experimental | Over the study, three participants were unable to complete all test sessions due to muscle pain or injury . Thus, 19 participants (age: 21.2±1.2 years; height: 1.76±0.8 m; body-mass: 76.6±12.6 kg) completed all test sessions Receives: Dietary Supplement: Energy Drink |
| Placebo drink | Placebo comparator | 19 participants (age: 21.2±1.2 years; height: 1.76±0.8 m; body-mass: 76.6±12.6 kg) Receives: Dietary Supplement: Placebo Drink |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Wingate-test physical performance from PL to RB condition
A calibrated mechanically-braked cycle ergometer (Monark 894; Stockholm, Sweden) interfaced with a microcomputer was utilized for the 30-s Wingate test. Subjects pedaled as fast as possible for 30-s against a constant load calculated according to the participant's body-mass (i.e., 8.7%). After maintaining a constant ~60rpm speed for 4-6-s against minimal resistance, the selected load was applied. The participant sat on the cycle throughout and was strongly encouraged to maximize pedaling rates and to maintain a high speed. Peak and mean power (i.e., average of power output the 30-s) were recorded. The fatigue index was calculated as follows:
Fatigue index (%) = [(peak power-minimal power)/ peak power×100]. The ICC and SEM showed excellent reliability for peak power (ICC>0.98, absolute SEM <0.21), mean power (ICC>0.98, absolute SEM <0.23) and fatigue index (ICC>0.76, absolute SEM <1.99).
Measured: The performance in Wingate test was measured 1 hour following the consumption of supplementations in the first and second test sessions (RB session and PLA session) to assess possible beneficial effect of RB supplementation in physical performance
Change in Reaction Time Performance from PL to RB condition
A simple visual reaction time test assessed alertness and motor reaction-speed. Subjects responded as quickly as possible to presentation of a stimulus (the image of a black box) on a computer screen (15" LCD). When this appears, the participant should press the index finger on a computer key. The signal appeared in random order within 1-10-s time intervals. Each participant was allowed ten attempts and the mean reaction time was calculated, using React! V0.9 software.The ICC and SEM showed excellent reliability for reaction time (ICC>0.89, absolute SEM <0.14) measurement.
Measured: The reaction time performance was measured 1 hour following the consumption of supplementations in the first and second test sessions (RB session and PLA session) to assess possible beneficial effect of RB in reaction time performance
Change in Strength Physical Performance (i.e., Handgrip) from PL to RB condition
Handgrip strength was recorded by dynamometer (T.K.K. 5401; Takei, Tokyo, Japan). The maximal handgrip force was determined for the dominant hand. Participants exerted their maximal strength for 4-5-s. With the hand hanging downwards, the dynamometer was
Measured: Handgrip performance was measured 1 hour following the consumption of supplementations in the first and second test sessions (RB session and PLA session) to assess possible beneficial effect of RB supplementation in strength (i.e., Handgrip) performance
Change in Rating of Perceived Exertion (RPE) and Affective Load from PL to RB condition
The original Borg RPE scale rates exertion subjectively during or after physical exercise on a 15-point scale ranging from six (very very light) to twenty (very very hard). It was used to calculate the affective load; the affective load was obtained as the difference between the perceived exertion (negative affective response) and pleasure scores (positive affective response). For example, with an RPE score of six, the negative affective response is zero and the positive affective response is -14. However, if the RPE score rises to 20, the negative affective response is +14 and the positive affective response is zero. The potential affective load thus ranges from -14 to +14. A negative affective load score indicates the dominance of pleasant affective responses and a positive affective load represents the dominance of unpleasant affective responses.
Measured: RPE and Affective Load were measured immediately following the first and second training sessions (RB and PL sessions) to assess any beneficial effect of the consumed RB (1 hour before session) on fatigue and load perception
Change in Mood States (POMS) from PL to RB condition
The evaluation of mood states used the French language version of the POMS questionnaire. Responses to 65 adjectives (ranging from "Zero" (i.e., not at all) to "Four" (i.e., extremely) assessed immediate mood states in seven dimensions: tension, depression, anger, vigor, fatigue, confusion and interpersonal relationships.
Measured: POMS was measured immediately following the first and second training sessions (RB and PL sessions) to assess any beneficial effect of the consumed RB (1hour before session) on perception of tension, depression, anger, vigor, fatigue, and confusion
Change in Blood pressure and blood glucose from pre- to post-training session using RB condition
Blood glucose was measured using the electrochemical sensor Rightest GM260 Blood Glucose Monitoring System (Bionime Corporation, Taichung City, Taiwan). The finger tip was pricked with a lancing device, and a specific test strip was soaked with blood was inserted into the measuring apparatus, with an estimate appearing within 5 seconds. Blood pressure was measured by the same physician using a stethoscope (Spengler, Germany) and sphygmomanometer (Spengler, Germany).
Measured: Blood pressure and blood glucose were measured 1 hour after RB supplementation (correspond to pre-training session) and also immediately following the training session to assess any exercise effect on blood pressure/glucose responses during RB condition
Change in Blood pressure and blood glucose from pre- to post-training session using PL condition
Blood glucose was measured using the electrochemical sensor Rightest GM260 Blood Glucose Monitoring System (Bionime Corporation, Taichung City, Taiwan). The finger tip was pricked with a lancing device, and a specific test strip was soaked with blood was inserted into the measuring apparatus, with an estimate appearing within 5 seconds. Blood pressure was measured by the same physician using a stethoscope (Spengler, Germany) and sphygmomanometer (Spengler, Germany).
Measured: Blood pressure and blood glucose were measured 1 hour after PL supplementation (correspond to pre-training session) and also immediately following the training session to assess any exercise effect on blood pressure/glucose responses during PL condition
Change in hematological parameters from pre- to post-training session using RB condition
Haematological parameters (i.e., white blood cells (WBC), neutrophils (NEU), red blood cells (RBC), hemoglobin (HGB), hematocrit (HCT)and platelets (PLT) were determined using a multichannel automated blood cell analyser Beckman Coulter Gen system-2 (Coulter T540)
Measured: Hematological parameters were measured 1 hour after RB supplementation (correspond to pre-training session) and also immediately following the training session to assess any exercise effect on hematological responses during RB condition
Change in hematological parameters from pre to post training session using PL condition
Haematological parameters (i.e., white blood cells (WBC), neutrophils (NEU), red blood cells (RBC), hemoglobin (HGB), hematocrit (HCT)and platelets (PLT) were determined using a multichannel automated blood cell analyser Beckman Coulter Gen system-2 (Coulter T540)
Measured: Hematological parameters were measured 1 hour after PL supplementation (correspond to pre-training session) and also immediately following the training session to assess any exercise effect on hematological responses during PL condition
Change in muscle damage parameters from pre to post training session using RB condition
muscle damage markers: Creatinine kinase (CK), Alkaline phosphate (PAL), Gammaglutamyl (GGT), Lactate dehydrogenase (LDH), and c-reactive protein (CRP) were determined spectrophotometrically using Abott Architect Ci 4100.
Measured: Muscle damage parameters were measured 1 hour after RB supplementation (correspond to pre-training session) and also immediately following the training session to assess any exercise effect on muscle damage responses during RB condition
Change in muscle damage parameters from pre to post training session using PL condition
muscle damage markers: Creatinine kinase (CK), Alkaline phosphate (PAL), Gammaglutamyl (GGT), Lactate dehydrogenase (LDH), and c-reactive protein (CRP) were determined spectrophotometrically using Abott Architect Ci 4100.
Measured: Muscle damage parameters were measured 1 hour after PL supplementation (correspond to pre-training session) and also immediately following the training session to assess any exercise effect on muscle damage responses during PL condition
Change in oxidative stress parameters from pre to post training session using RB condition
Oxididative stress response (i.e., malondialdehyde (MDA), superoxide dismutase (SOD), glutathione peroxidase (GPx), Catalase (CAT), uric acid (UA)) and c-reactive protein (CRP)) were determined spectrophotometrically using Abott Architect Ci 4100.
Measured: Oxidative stress parameters were measured 1 hour after RB supplementation (correspond to pre-training session) and also immediately following the training session to assess any exercise effect on oxidative stress responses during RB condition
Change in oxidative stress parameters from pre to post training session using PL condition
Oxididative stress response (i.e., malondialdehyde (MDA), superoxide dismutase (SOD), glutathione peroxidase (GPx), Catalase (CAT), uric acid (UA)) and c-reactive protein (CRP)) were determined spectrophotometrically using Abott Architect Ci 4100.
Measured: Oxidative stress parameters were measured 1 hour after PL supplementation (correspond to pre-training session) and also immediately following the training session to assess any exercise effect on oxidative stress responses during PL condition
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2019
- Study start1 Jan 2017
- Primary completion12 Jan 2017
- Study completion12 Jan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Physical ActivityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- A double blind, placebo-controlled, and counterbalanced crossover design was used for this work
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Higher Institute of Sport and Physical Education of Sfax
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ammar Achraf, The Higher Institute of Sport and Physical Education of Sfax
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03936712
- Sponsor's protocol ID
- Hamdi Chtourou
- Status last verified
- May 2019
- First submitted
- 24 Apr 2019
- Last updated
- 3 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Energy Drink on Performance and Psycho-Physiological Response to Physical Exercise
- ClinicalTrials.gov ID
- NCT03936712
- Acronym / sponsor ID
- Hamdi Chtourou
- Conditions
- Physical Activity
- Keywords
- Energy drinks, Exercise, Physiological response, Mood State, Fatigue
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- The Higher Institute of Sport and Physical Education of SfaxUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 12 Jan 2017 (actual)
- Study completion
- 12 Jan 2017 (actual)
- First posted
- 3 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This work aimed to examine the effects of drinking an "energy drink" upon (i) short-term maximal performance, (ii) reaction times and (iii) psychological factors (i.e., mood state, ratings of perceived exertion (RPE) and affective load) and on physiological parameters such as blood pressure, blood glucose, hematological parameters and other biochemical parameters.
Detailed description
A total of 22 healthy and regularly active physical-education male students from various sports disciplines volunteered to participate in this study. Potential participants were initially screened through telephone interviews based on the inclusion criteria: 18-40 years of age, BMI less than 25 kg/m2, and low (<1.5g/month ) and not regular caffeine users. Exclusion criteria included diagnosis of any chronic metabolic disease such as type 2 diabetes or cardiovascular disease, an auto-immune disease such as rheumatoid arthritis, lupus or type 1 diabetes, liver disease and the intake of any medications/ or dietary supplements known to influence blood glucose concentrations and/or blood pressures.
The study was conducted according to the declaration of Helsinki and the protocol was fully approved (identification code: 8/16) by the review board "Local committee of the Laboratory of Biochemistry, CHU Habib Bourguiba, Sfax, Tunisia." After a throughout explanation of the protocol and responses to all questions, participants signed a written informed consent.
Subjects were instructed to avoid nicotine, alcohol, dietary supplements, medications and all other stimulants and to maintain their normal dietary, sleep and physical activity patterns before test sessions. Caffeine and other caffeinated products (e.g., chocolate, caffeinated gums, caffeine containing beverages) were avoided for 48 hours and food for at least 4 hours before testing.
A double blind, placebo-controlled, counterbalanced, crossover design was adopted for this study. The randomized order of testing was determined using free online software (www.randomization.com). Neither staff nor participants were informed about the names of the two drinks, and blinding was strictly maintained by emphasizing to both staff and participants that both drinks adhered to healthy principles, and that each was advocated by certain sports medicine experts. Two familiarization sessions were completed before definitive test sessions in order to eliminate any learning effects on physical performance and reaction time measurements. During the second familiarization session, body mass and height were recorded. Each participant visited the laboratory for two formal test sessions, drinking a caffeine-containing ED (RB) and a caffeine and taurine free beverage drink (PL). All sessions were arranged in the early evening hours to avoid any time of day effects. The two definitive test sessions were separated by an interval of seven days to allow sufficient recovery between tests and to ensure caffeine washout. To avoid identification, two opaque and unmarked cans of RB or PL were ingested by each participant (i.e., 500 mL) in the presence of a researcher. The two drinks were similar in volume, texture, and appearance. One can of RB drink (i.e., 250ml) contained 80 mg of caffeine, 1 g of taurine, 27 g of carbohydrates, 0.6 g of protein, 5 mg vitamin B6 and 487 kJ of energy. The PL drink was prepared by an agri-food engineer; it did not contain any caffeine or taurine, but comprised carbonated water, carbohydrates, citric acid lemon juice reconstituted from concentrate (1 %), supplemented by flavorings, of sodium citrate, acesulfame K, sucralose, potassium sorbate and RB (a flavoring that contains propylene glycol E1520 (0.23 mL).
Beverages were prepared, shaken and chilled in a refrigerator at 14h00 by an investigator who took no part in the test sessions or data analysis, but prepared the alphanumeric code identifying the tested drink. At 17h00, the cooled beverages were served in sealed plastic opaque water bottles and consumed using an opaque straw. Participants were instructed to drink the fluid quickly (within 1±0.5 min) 60 minutes before their test session and not to discuss or compare tastes or to make any assumptions about what they had ingested. The interval of 60 minutes was chosen as optimal for a complete caffeine absorption and thus a peaking of a caffeine concentration .
Subjects were supervised by staff to ensure that they drank the entire quantity of fluid, and no exchange of bottles was allowed. The last standardized meal (i.e., lunch) before the beginning of the test session was taken at 13h00. Temperature and relative humidity of the laboratory were similar over the test sessions, with a temperature of around 22°C and a relative humidity between 45 and 55 %. During each test session (from 18h00), resting blood glucose and blood pressures were measured and the participants completed the POMS questionnaire.
A 5-min treadmill warm-up was performed. After that, the reaction time, and handgrip force were determined, and the 30-s Wingate test was performed. RPE scores, blood glucose and blood pressures were then measured, and the affective load was calculated. To investigate the effects of RB on the acute physiological and psychological responses to exercise, blood measures and psychological test measures were collected immediately pre- and post-exercise.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- A double blind, placebo-controlled, and counterbalanced crossover design was used for this work
| Arm | Type | Receives |
|---|---|---|
| Red Bull drink (RB) | Experimental | Dietary Supplement: Energy DrinkOver the study, three participants were unable to complete all test sessions due to muscle pain or injury . Thus, 19 participants (age: 21.2±1.2 years; height: 1.76±0.8 m; body-mass: 76.6±12.6 kg) completed all test sessions |
| Placebo drink | Placebo comparator | Dietary Supplement: Placebo Drink19 participants (age: 21.2±1.2 years; height: 1.76±0.8 m; body-mass: 76.6±12.6 kg) |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 18-40 years of age,
- BMI less than 25 kg/m2,
- low (<1.5g/month [20]) caffeine users
- not regular caffeine users.
Key exclusion criteria (4 listed)
- chronic metabolic disease such as type 2 diabetes and cardiovascular disease
- auto-immune disease such as rheumatoid arthritis, lupus or type 1 diabetes,
- liver disease
- intake of any medications/ or dietary supplements known to influence blood glucose and/or blood pressures.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Energy DrinkEach participant visited the laboratory for two formal test sessions, drinking a caffeine-containing ED (RB) and a caffeine and taurine free beverage drink (PL). All sessions were arranged in the early evening hours to avoid any time of day effects. The two definitive test sessions were separated by an interval of seven days to allow sufficient recovery between tests and to ensure caffeine washout. To avoid identification, two opaque and unmarked cans of RB or PL were ingested by each participant (i.e., 500 mL) in the presence of a researcher. The two drinks were similar in volume, texture, and appearance. One can of RB drink (i.e., 250ml) contained 80 mg of caffeine, 1 g of taurine, 27 g of carbohydrates, 0.6 g of protein, 5 mg vitamin B6 and 487 kJ of energy. | Dietary supplement | Red Bull drink (RB) |
| Placebo DrinkThe PL drink was prepared by an agri-food engineer; it did not contain any caffeine or taurine, but comprised carbonated water, carbohydrates, citric acid lemon juice reconstituted from concentrate (1 %), supplemented by flavorings, of sodium citrate, acesulfame K, sucralose, potassium sorbate and RB (a flavoring that contains propylene glycol E1520 (0.23 mL). | Dietary supplement | Placebo drink |
Primary outcome
Change in Wingate-test physical performance from PL to RB condition
Time frame: The performance in Wingate test was measured 1 hour following the consumption of supplementations in the first and second test sessions (RB session and PLA session) to assess possible beneficial effect of RB supplementation in physical performance
A calibrated mechanically-braked cycle ergometer (Monark 894; Stockholm, Sweden) interfaced with a microcomputer was utilized for the 30-s Wingate test. Subjects pedaled as fast as possible for 30-s against a constant load calculated according to the participant's body-mass (i.e., 8.7%). After maintaining a constant ~60rpm speed for 4-6-s against minimal resistance, the selected load was applied. The participant sat on the cycle throughout and was strongly encouraged to maximize pedaling rates and to maintain a high speed. Peak and mean power (i.e., average of power output the 30-s) were recorded. The fatigue index was calculated as follows: Fatigue index (%) = [(peak power-minimal power)/ peak power×100]. The ICC and SEM showed excellent reliability for peak power (ICC>0.98, absolute SEM <0.21), mean power (ICC>0.98, absolute SEM <0.23) and fatigue index (ICC>0.76, absolute SEM <1.99).
Change in Reaction Time Performance from PL to RB condition
Time frame: The reaction time performance was measured 1 hour following the consumption of supplementations in the first and second test sessions (RB session and PLA session) to assess possible beneficial effect of RB in reaction time performance
A simple visual reaction time test assessed alertness and motor reaction-speed. Subjects responded as quickly as possible to presentation of a stimulus (the image of a black box) on a computer screen (15" LCD). When this appears, the participant should press the index finger on a computer key. The signal appeared in random order within 1-10-s time intervals. Each participant was allowed ten attempts and the mean reaction time was calculated, using React! V0.9 software.The ICC and SEM showed excellent reliability for reaction time (ICC>0.89, absolute SEM <0.14) measurement.
Change in Strength Physical Performance (i.e., Handgrip) from PL to RB condition
Time frame: Handgrip performance was measured 1 hour following the consumption of supplementations in the first and second test sessions (RB session and PLA session) to assess possible beneficial effect of RB supplementation in strength (i.e., Handgrip) performance
Handgrip strength was recorded by dynamometer (T.K.K. 5401; Takei, Tokyo, Japan). The maximal handgrip force was determined for the dominant hand. Participants exerted their maximal strength for 4-5-s. With the hand hanging downwards, the dynamometer was
Change in Rating of Perceived Exertion (RPE) and Affective Load from PL to RB condition
Time frame: RPE and Affective Load were measured immediately following the first and second training sessions (RB and PL sessions) to assess any beneficial effect of the consumed RB (1 hour before session) on fatigue and load perception
The original Borg RPE scale rates exertion subjectively during or after physical exercise on a 15-point scale ranging from six (very very light) to twenty (very very hard). It was used to calculate the affective load; the affective load was obtained as the difference between the perceived exertion (negative affective response) and pleasure scores (positive affective response). For example, with an RPE score of six, the negative affective response is zero and the positive affective response is -14. However, if the RPE score rises to 20, the negative affective response is +14 and the positive affective response is zero. The potential affective load thus ranges from -14 to +14. A negative affective load score indicates the dominance of pleasant affective responses and a positive affective load represents the dominance of unpleasant affective responses.
Change in Mood States (POMS) from PL to RB condition
Time frame: POMS was measured immediately following the first and second training sessions (RB and PL sessions) to assess any beneficial effect of the consumed RB (1hour before session) on perception of tension, depression, anger, vigor, fatigue, and confusion
The evaluation of mood states used the French language version of the POMS questionnaire. Responses to 65 adjectives (ranging from "Zero" (i.e., not at all) to "Four" (i.e., extremely) assessed immediate mood states in seven dimensions: tension, depression, anger, vigor, fatigue, confusion and interpersonal relationships.
Change in Blood pressure and blood glucose from pre- to post-training session using RB condition
Time frame: Blood pressure and blood glucose were measured 1 hour after RB supplementation (correspond to pre-training session) and also immediately following the training session to assess any exercise effect on blood pressure/glucose responses during RB condition
Blood glucose was measured using the electrochemical sensor Rightest GM260 Blood Glucose Monitoring System (Bionime Corporation, Taichung City, Taiwan). The finger tip was pricked with a lancing device, and a specific test strip was soaked with blood was inserted into the measuring apparatus, with an estimate appearing within 5 seconds. Blood pressure was measured by the same physician using a stethoscope (Spengler, Germany) and sphygmomanometer (Spengler, Germany).
Change in Blood pressure and blood glucose from pre- to post-training session using PL condition
Time frame: Blood pressure and blood glucose were measured 1 hour after PL supplementation (correspond to pre-training session) and also immediately following the training session to assess any exercise effect on blood pressure/glucose responses during PL condition
Blood glucose was measured using the electrochemical sensor Rightest GM260 Blood Glucose Monitoring System (Bionime Corporation, Taichung City, Taiwan). The finger tip was pricked with a lancing device, and a specific test strip was soaked with blood was inserted into the measuring apparatus, with an estimate appearing within 5 seconds. Blood pressure was measured by the same physician using a stethoscope (Spengler, Germany) and sphygmomanometer (Spengler, Germany).
Change in hematological parameters from pre- to post-training session using RB condition
Time frame: Hematological parameters were measured 1 hour after RB supplementation (correspond to pre-training session) and also immediately following the training session to assess any exercise effect on hematological responses during RB condition
Haematological parameters (i.e., white blood cells (WBC), neutrophils (NEU), red blood cells (RBC), hemoglobin (HGB), hematocrit (HCT)and platelets (PLT) were determined using a multichannel automated blood cell analyser Beckman Coulter Gen system-2 (Coulter T540)
Change in hematological parameters from pre to post training session using PL condition
Time frame: Hematological parameters were measured 1 hour after PL supplementation (correspond to pre-training session) and also immediately following the training session to assess any exercise effect on hematological responses during PL condition
Haematological parameters (i.e., white blood cells (WBC), neutrophils (NEU), red blood cells (RBC), hemoglobin (HGB), hematocrit (HCT)and platelets (PLT) were determined using a multichannel automated blood cell analyser Beckman Coulter Gen system-2 (Coulter T540)
Change in muscle damage parameters from pre to post training session using RB condition
Time frame: Muscle damage parameters were measured 1 hour after RB supplementation (correspond to pre-training session) and also immediately following the training session to assess any exercise effect on muscle damage responses during RB condition
muscle damage markers: Creatinine kinase (CK), Alkaline phosphate (PAL), Gammaglutamyl (GGT), Lactate dehydrogenase (LDH), and c-reactive protein (CRP) were determined spectrophotometrically using Abott Architect Ci 4100.
Change in muscle damage parameters from pre to post training session using PL condition
Time frame: Muscle damage parameters were measured 1 hour after PL supplementation (correspond to pre-training session) and also immediately following the training session to assess any exercise effect on muscle damage responses during PL condition
muscle damage markers: Creatinine kinase (CK), Alkaline phosphate (PAL), Gammaglutamyl (GGT), Lactate dehydrogenase (LDH), and c-reactive protein (CRP) were determined spectrophotometrically using Abott Architect Ci 4100.
Change in oxidative stress parameters from pre to post training session using RB condition
Time frame: Oxidative stress parameters were measured 1 hour after RB supplementation (correspond to pre-training session) and also immediately following the training session to assess any exercise effect on oxidative stress responses during RB condition
Oxididative stress response (i.e., malondialdehyde (MDA), superoxide dismutase (SOD), glutathione peroxidase (GPx), Catalase (CAT), uric acid (UA)) and c-reactive protein (CRP)) were determined spectrophotometrically using Abott Architect Ci 4100.
Change in oxidative stress parameters from pre to post training session using PL condition
Time frame: Oxidative stress parameters were measured 1 hour after PL supplementation (correspond to pre-training session) and also immediately following the training session to assess any exercise effect on oxidative stress responses during PL condition
Oxididative stress response (i.e., malondialdehyde (MDA), superoxide dismutase (SOD), glutathione peroxidase (GPx), Catalase (CAT), uric acid (UA)) and c-reactive protein (CRP)) were determined spectrophotometrically using Abott Architect Ci 4100.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2019.
- Individual participant dataSharing planned: No
Related trials for Physical Activity
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruiting
Feasibility of a Robot-Guided Active Play Intervention for Children With Cerebral Palsy
Cerebral Palsy
Enrolling by invitation
Online Exercise Program for Transplant Patients: A Pilot Study
Kidney Transplantation, Physical Function
Recruiting
Effect of a Brief Daily Digital Meditation on Well-Being in US Young Adults (BEGIN II)
Mental Health and General Well-being
RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life(COREVIVE-HFrEF)
Heart Failure With Reduced Ejection Fraction, Iron Deficiency
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Energy Drink in people with Physical Activity, run by The Higher Institute of Sport and Physical Education of Sfax.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 May 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Wingate-test physical performance from PL to RB condition (time frame: The performance in Wingate test was measured 1 hour following the consumption of supplementations in the first and second test sessions (RB session and PLA session) to assess possible beneficial effect of RB supplementation in physical performance). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2019.