Sport PerformanceNCT06059911
Pre-workout Supplementation and Basketball
A study testing Multi-ingredient dietary supplement (caffeine, creatine monohydrate, β-alanine, citrulline malate, BCAA) in people with Sport Performance, run by Athanasios Z. Jamurtas at 1 site in Greece.
Trial summary
Pre-workout supplements (PWS) consumption in recreationally or physically trained males lead to many performance-enhancing benefits, including improvements in mean power output during single and repeated sprints, agility, reaction times, lower body muscular endurance and reduced fatigue. Read more about this study
- Who is it for?
- Ages 18 to 41 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Sport Performance
- What is being tested?
- Multi-ingredient dietary supplement (caffeine, creatine monohydrate, β-alanine, citrulline malate, BCAA)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteGreece
- Study dates
- 15 Jun 2022to 15 Jun 2024
- 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 41 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male participants, 18-41 years old
- Absence of drugs, abuse or medications, which are known to affect the Shooting, sprinting, jumping, agility, anaerobic and endurance performance
- Consent to follow a regular dietary plan for basketball players
Who cannot join
- Restraining orthopedic/neuromuscular problems
- Caffeine hypersensitivity
- Consumption of more than three servings of coffee per day
- Use of any supplement or steroids prior to the study
- Use of creatine, β-alanine, citrulline malate or BCAA-protein supplementation at least six months before the initiation of the study
Trial locations and contacts
1 site in 1 country.
Greece1 site
Sports Nutrition Laboratory, International Hellenic University
Thessaloniki
About this study
Official title: The Effect of a Pre-workout Supplement on Basketball-specific Performance and Biochemical Profile of Well-trained Athletes
Pre-workout supplements (PWS) consumption in recreationally or physically trained males lead to many performance-enhancing benefits, including improvements in mean power output during single and repeated sprints, agility, reaction times, lower body muscular endurance and reduced fatigue. PWS ingestion also improves anaerobic performance and prolongs time to exhaustion during high-intensity intermittent exercise. However, PWSs' effectiveness is not constant, as they do not alter anaerobic power, jumping performance or blood lactate concentrations after a training session, at least in recreationally trained males and strength-power athletes. Moreover, the effects of long-term PWS supplementation, where some nutritional agents were combined (e.g., β-alanine, creatine, citrulline malate, etc.) to assess endurance-trained runners or elite cyclists' performance, are mixed and less clear. Even though the popularity of PWS use has increased among trained/professional athletes, most of the data in this area are derived from recreationally and not from well-trained athletes of a competitive level (especially in team sports). Therefore, the present study aimed to examine the acute and chronic effects of a PWS, containing 200 mg caffeine, 3.3 g creatine monohydrate, 3.2 g βalanine, 6 g citrulline malate and 5 g BCAA per dose, on shooting, jumping, sprinting, agility, aerobic and anaerobic performance in well-trained basketball players.
Read the detailed description
According to a randomized, double-blind, placebo-controlled, research design, 36 well-trained male basketball players will be recruited. During their first visit, they will complete a health history and exercise questionnaire and will sign a written informed consent. Participants' dietary profile will be evaluated using 3- day diet recalls and they will be instructed to follow the same dietary scheme for 3 days prior to the subsequent evaluations. During the second visit, participants will be familiarized with the performance evaluations (shooting, jumping, sprinting, agility, running-based anaerobic sprint test and Yo-Yo intermittent recovery level 1 test).
(Acute phase) One week later, Moreover, they will randomly be assigned in two groups (PWS and placebo) by a research member not involved in data collection. After that participants will visit the basketball court in the morning and a blood sample will be collected after overnight fasting. Afterward, the participants in each group will perform the evaluations without PWS or PL. The evaluations will be performed according to National Strength and Conditioning Association standards. Body composition, resting heart rate, blood pressure, basketball-specific shooting exercise, counter-movement jump, 20-m sprint, agility T-Test, running-based anaerobic sprint test and Yo-Yo intermittent recovery level 1 test. One week later, all participants will visit the same basketball court at the same hour and will consume the PWS or placebo supplement and 30 minutes later their physiological characteristics and performance will be evaluated in the same sequence.
(Chronic phase) Following the evaluations of the acute phase, participants will continue the consumption of the PWS or placebo, according to their allocation group, daily for a period of 4 weeks. At the end of the supplementation period, participants will visit the basketball court and a second blood sample will be collected after overnight fasting (the first blood sample, collected before the acute phase evaluations, will serve as baseline). Then, participants' performance will be evaluated in the same sequence as the previous visit.
- Conditions
- Sport Performance
- Being tested
- Multi-ingredient dietary supplement (caffeine, creatine monohydrate, β-alanine, citrulline malate, BCAA), Placebo dietary supplement (97% maltodextrin)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multi-ingredient dietary supplement (caffeine, creatine monohydrate, β-alanine, citrulline malate, BCAA)Dietary supplement
Administration of a multi-ingredient dietary supplement consisting of 200 mg caffeine, 3.3 g creatine monohydrate, 3.2 g β-alanine, 6 g citrulline malate and 5 g branched chain amino acids
Placebo dietary supplement (97% maltodextrin)Dietary supplement
Administration of an isoenergetic placebo comparator dietary supplement consisting of 97% maltodextrin
| Study group | Role | What they receive |
|---|---|---|
| Multi-ingredient dietary supplement | Experimental | 20 g of a multi-ingredient dietary supplement. Composition: 200 mg caffeine, 3.3 g creatine monohydrate, 3.2 g β-alanine, 6 g citrulline malate and 5 g BCAA Receives: Dietary Supplement: Multi-ingredient dietary supplement (caffeine, creatine monohydrate, β-alanine, citrulline malate, BCAA) |
| Placebo dietary supplement (97% maltodextrin) | Placebo comparator | 20 g of isoenergetic placebo dietary supplement. Composition: 97% flavored maltodextrin, similar in color, flavor, taste and energy to the experimental multi-ingredient supplement Receives: Dietary Supplement: Placebo dietary supplement (97% maltodextrin) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Countermovement jump height
Jumping performance will be evaluated using a contact platform
Measured: baseline and up to 4 weeks
20 meters sprint running time
Sprint performance will be evaluated using photocell gates
Measured: baseline and up to 4 weeks
Rate of agility T-test performance
Agility T-test will be evaluated using photocell gates
Measured: baseline and up to 4 weeks
Rate of running-based anaerobic sprint test performance
Running-based anaerobic sprint test performance will be evaluated using photocell gates
Measured: baseline and up to 4 weeks
Rate of Yo-Yo intermittent recovery test level 1 test performance
Yo-Yo intermittent recovery test level 1 test performance will be evaluated using a field-based test
Measured: baseline and up to 4 weeks
Rate of basketball-specific shooting performance
Basketball-specific shooting performance will be evaluated with a test consisting of 30 free shoots, 30 middle-distance shoots and 30 long-distance shoots
Measured: baseline and up to 4 weeks
Blood lactate concentartion
Blood lactate concentration will be measured using a portable blood lactate analyzer
Measured: baseline and up to 4 weeks
Creatine kinase concentration
Creatine kinase activity will be measured on a clinical chemistry analyzer
Measured: baseline and up to 4 weeks
Lactate dehydrogenase concentration
Lactate dehydrogenase will be measured on a clinical chemistry analyzer
Measured: baseline and up to 4 weeks
Alkaline phosphatase concentration
Alkaline phosphatase will be measured on a clinical chemistry analyzer
Measured: baseline and up to 4 weeks
Gamma-glutamyltransferase concentration
Gamma-glutamyltransferase will be measured on a clinical chemistry analyzer
Measured: baseline and up to 4 weeks
Urea concentration
Urea will be measured on a clinical chemistry analyzer
Measured: baseline and up to 4 weeks
Creatinine concentration
Creatinine will be measured on a clinical chemistry analyzer
Measured: baseline and up to 4 weeks
Serum glutamic-oxaloacetic transaminase activity
Serum glutamic-oxaloacetic transaminase will be measured on a clinical chemistry analyzer
Measured: baseline and up to 4 weeks
Serum glutamate-pyruvate transaminase activity
Serum glutamate-pyruvate transaminase will be measured on a clinical chemistry analyzer
Measured: baseline and up to 4 weeks
Secondary outcomes (5)
Body mass
Body mass will be measured using a calibrated digital scale
Measured: baseline and up to 4 weeks
Body height
Body height will be measured using a stadiometer
Measured: baseline and up to 4 weeks
Body fat mass
Body fat mass will be measured using a calibrated digital scale via bioelectrical impedance analysis
Measured: baseline and up to 4 weeks
Systolic and diastolic blood pressure
Systolic and diastolic blood pressure will be measured using a blood pressure monitor
Measured: baseline and up to 4 weeks
Heart rate
Heart rate will be measured using a heart rate monitor
Measured: baseline and up to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2023
- Study start15 Jun 2022
- Primary completion15 Dec 2023 (estimated)
- Study completion15 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sport PerformanceStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Athanasios Z. Jamurtas
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Athanasios Z. Jamurtas, University of Thessaly
- Investigators
- Sousana K Papadopoulou, Study director, International Hellenic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06059911
- Sponsor's protocol ID
- Douligeris Study
- Status last verified
- Sep 2023
- First submitted
- 15 Sep 2023
- Last updated
- 3 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of a Pre-workout Supplement on Basketball-specific Performance and Biochemical Profile of Well-trained Athletes
- ClinicalTrials.gov ID
- NCT06059911
- Acronym / sponsor ID
- Douligeris Study
- Conditions
- Sport Performance
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Athanasios Z. JamurtasUniversity, hospital or other
- Study start
- 15 Jun 2022 (actual)
- Primary completion
- 15 Dec 2023 (estimated)
- Study completion
- 15 Jun 2024 (estimated)
- First posted
- 29 Sep 2023 (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.
Pre-workout supplements (PWS) consumption in recreationally or physically trained males lead to many performance-enhancing benefits, including improvements in mean power output during single and repeated sprints, agility, reaction times, lower body muscular endurance and reduced fatigue. PWS ingestion also improves anaerobic performance and prolongs time to exhaustion during high-intensity intermittent exercise. However, PWSs' effectiveness is not constant, as they do not alter anaerobic power, jumping performance or blood lactate concentrations after a training session, at least in recreationally trained males and strength-power athletes. Moreover, the effects of long-term PWS supplementation, where some nutritional agents were combined (e.g., β-alanine, creatine, citrulline malate, etc.) to assess endurance-trained runners or elite cyclists' performance, are mixed and less clear. Even though the popularity of PWS use has increased among trained/professional athletes, most of the data in this area are derived from recreationally and not from well-trained athletes of a competitive level (especially in team sports). Therefore, the present study aimed to examine the acute and chronic effects of a PWS, containing 200 mg caffeine, 3.3 g creatine monohydrate, 3.2 g βalanine, 6 g citrulline malate and 5 g BCAA per dose, on shooting, jumping, sprinting, agility, aerobic and anaerobic performance in well-trained basketball players.
Detailed description
According to a randomized, double-blind, placebo-controlled, research design, 36 well-trained male basketball players will be recruited. During their first visit, they will complete a health history and exercise questionnaire and will sign a written informed consent. Participants' dietary profile will be evaluated using 3- day diet recalls and they will be instructed to follow the same dietary scheme for 3 days prior to the subsequent evaluations. During the second visit, participants will be familiarized with the performance evaluations (shooting, jumping, sprinting, agility, running-based anaerobic sprint test and Yo-Yo intermittent recovery level 1 test).
(Acute phase) One week later, Moreover, they will randomly be assigned in two groups (PWS and placebo) by a research member not involved in data collection. After that participants will visit the basketball court in the morning and a blood sample will be collected after overnight fasting. Afterward, the participants in each group will perform the evaluations without PWS or PL. The evaluations will be performed according to National Strength and Conditioning Association standards. Body composition, resting heart rate, blood pressure, basketball-specific shooting exercise, counter-movement jump, 20-m sprint, agility T-Test, running-based anaerobic sprint test and Yo-Yo intermittent recovery level 1 test. One week later, all participants will visit the same basketball court at the same hour and will consume the PWS or placebo supplement and 30 minutes later their physiological characteristics and performance will be evaluated in the same sequence.
(Chronic phase) Following the evaluations of the acute phase, participants will continue the consumption of the PWS or placebo, according to their allocation group, daily for a period of 4 weeks. At the end of the supplementation period, participants will visit the basketball court and a second blood sample will be collected after overnight fasting (the first blood sample, collected before the acute phase evaluations, will serve as baseline). Then, participants' performance will be evaluated in the same sequence as the previous visit.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Multi-ingredient dietary supplement | Experimental | Dietary Supplement: Multi-ingredient dietary supplement (caffeine, creatine monohydrate, β-alanine, citrulline malate, BCAA)20 g of a multi-ingredient dietary supplement. Composition: 200 mg caffeine, 3.3 g creatine monohydrate, 3.2 g β-alanine, 6 g citrulline malate and 5 g BCAA |
| Placebo dietary supplement (97% maltodextrin) | Placebo comparator | Dietary Supplement: Placebo dietary supplement (97% maltodextrin)20 g of isoenergetic placebo dietary supplement. Composition: 97% flavored maltodextrin, similar in color, flavor, taste and energy to the experimental multi-ingredient supplement |
Who may qualify
- Ages
- 18 to 41 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Male participants, 18-41 years old
- Absence of drugs, abuse or medications, which are known to affect the Shooting, sprinting, jumping, agility, anaerobic and endurance performance
- Consent to follow a regular dietary plan for basketball players
Key exclusion criteria (5 listed)
- Restraining orthopedic/neuromuscular problems
- Caffeine hypersensitivity
- Consumption of more than three servings of coffee per day
- Use of any supplement or steroids prior to the study
- Use of creatine, β-alanine, citrulline malate or BCAA-protein supplementation at least six months before the initiation of the study
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 |
|---|---|---|
| Multi-ingredient dietary supplement (caffeine, creatine monohydrate, β-alanine, citrulline malate, BCAA)Administration of a multi-ingredient dietary supplement consisting of 200 mg caffeine, 3.3 g creatine monohydrate, 3.2 g β-alanine, 6 g citrulline malate and 5 g branched chain amino acids | Dietary supplement | Multi-ingredient dietary supplement |
| Placebo dietary supplement (97% maltodextrin)Administration of an isoenergetic placebo comparator dietary supplement consisting of 97% maltodextrin | Dietary supplement | Placebo dietary supplement (97% maltodextrin) |
Primary outcome
Countermovement jump height
Time frame: baseline and up to 4 weeks
Jumping performance will be evaluated using a contact platform
20 meters sprint running time
Time frame: baseline and up to 4 weeks
Sprint performance will be evaluated using photocell gates
Rate of agility T-test performance
Time frame: baseline and up to 4 weeks
Agility T-test will be evaluated using photocell gates
Rate of running-based anaerobic sprint test performance
Time frame: baseline and up to 4 weeks
Running-based anaerobic sprint test performance will be evaluated using photocell gates
Rate of Yo-Yo intermittent recovery test level 1 test performance
Time frame: baseline and up to 4 weeks
Yo-Yo intermittent recovery test level 1 test performance will be evaluated using a field-based test
Rate of basketball-specific shooting performance
Time frame: baseline and up to 4 weeks
Basketball-specific shooting performance will be evaluated with a test consisting of 30 free shoots, 30 middle-distance shoots and 30 long-distance shoots
Blood lactate concentartion
Time frame: baseline and up to 4 weeks
Blood lactate concentration will be measured using a portable blood lactate analyzer
Creatine kinase concentration
Time frame: baseline and up to 4 weeks
Creatine kinase activity will be measured on a clinical chemistry analyzer
Lactate dehydrogenase concentration
Time frame: baseline and up to 4 weeks
Lactate dehydrogenase will be measured on a clinical chemistry analyzer
Alkaline phosphatase concentration
Time frame: baseline and up to 4 weeks
Alkaline phosphatase will be measured on a clinical chemistry analyzer
Gamma-glutamyltransferase concentration
Time frame: baseline and up to 4 weeks
Gamma-glutamyltransferase will be measured on a clinical chemistry analyzer
Urea concentration
Time frame: baseline and up to 4 weeks
Urea will be measured on a clinical chemistry analyzer
Creatinine concentration
Time frame: baseline and up to 4 weeks
Creatinine will be measured on a clinical chemistry analyzer
Serum glutamic-oxaloacetic transaminase activity
Time frame: baseline and up to 4 weeks
Serum glutamic-oxaloacetic transaminase will be measured on a clinical chemistry analyzer
Serum glutamate-pyruvate transaminase activity
Time frame: baseline and up to 4 weeks
Serum glutamate-pyruvate transaminase will be measured on a clinical chemistry analyzer
5 secondary outcomes
Body mass
Time frame: baseline and up to 4 weeks
Body height
Time frame: baseline and up to 4 weeks
Body fat mass
Time frame: baseline and up to 4 weeks
Systolic and diastolic blood pressure
Time frame: baseline and up to 4 weeks
Heart rate
Time frame: baseline and up to 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2023.
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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.
Sousana K Papadopoulou study director
International Hellenic University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multi-ingredient dietary supplement (caffeine, creatine monohydrate, β-alanine, citrulline malate, BCAA) in people with Sport Performance, run by Athanasios Z. Jamurtas at 1 site in Greece.
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 3 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 3 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
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?
Countermovement jump height (time frame: baseline and up to 4 weeks). The study lists 15 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 Oct 2023; AzTrials last refreshed its copy on 29 Oct 2026.