- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06059911
Pre-workout Supplementation and Basketball
The Effect of a Pre-workout Supplement on Basketball-specific Performance and Biochemical Profile of Well-trained Athletes
Study Overview
Status
Conditions
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Thessaloníki, Greece
- Sports Nutrition Laboratory, International Hellenic University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Multi-ingredient dietary supplement
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
|
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 Comparator: 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
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Administration of an isoenergetic placebo comparator dietary supplement consisting of 97% maltodextrin
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Countermovement jump height
Time Frame: baseline and up to 4 weeks
|
Jumping performance will be evaluated using a contact platform
|
baseline and up to 4 weeks
|
|
20 meters sprint running time
Time Frame: baseline and up to 4 weeks
|
Sprint performance will be evaluated using photocell gates
|
baseline and up to 4 weeks
|
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Rate of agility T-test performance
Time Frame: baseline and up to 4 weeks
|
Agility T-test will be evaluated using photocell gates
|
baseline and up to 4 weeks
|
|
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
|
baseline and up to 4 weeks
|
|
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
|
baseline and up to 4 weeks
|
|
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
|
baseline and up to 4 weeks
|
|
Blood lactate concentartion
Time Frame: baseline and up to 4 weeks
|
Blood lactate concentration will be measured using a portable blood lactate analyzer
|
baseline and up to 4 weeks
|
|
Urea concentration
Time Frame: baseline and up to 4 weeks
|
Urea will be measured on a clinical chemistry analyzer
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baseline and up to 4 weeks
|
|
Creatinine concentration
Time Frame: baseline and up to 4 weeks
|
Creatinine will be measured on a clinical chemistry analyzer
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baseline and up to 4 weeks
|
|
Serum glutamic-oxaloacetic transaminase activity
Time Frame: baseline and up to 4 weeks
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Serum glutamic-oxaloacetic transaminase will be measured on a clinical chemistry analyzer
|
baseline and up to 4 weeks
|
|
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
|
baseline and up to 4 weeks
|
|
Creatine kinase concentration
Time Frame: baseline and up to 4 weeks
|
Creatine kinase activity will be measured on a clinical chemistry analyzer
|
baseline and up to 4 weeks
|
|
Lactate dehydrogenase concentration
Time Frame: baseline and up to 4 weeks
|
Lactate dehydrogenase will be measured on a clinical chemistry analyzer
|
baseline and up to 4 weeks
|
|
Alkaline phosphatase concentration
Time Frame: baseline and up to 4 weeks
|
Alkaline phosphatase will be measured on a clinical chemistry analyzer
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baseline and up to 4 weeks
|
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Gamma-glutamyltransferase concentration
Time Frame: baseline and up to 4 weeks
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Gamma-glutamyltransferase will be measured on a clinical chemistry analyzer
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baseline and up to 4 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Body mass
Time Frame: baseline and up to 4 weeks
|
Body mass will be measured using a calibrated digital scale
|
baseline and up to 4 weeks
|
|
Body height
Time Frame: baseline and up to 4 weeks
|
Body height will be measured using a stadiometer
|
baseline and up to 4 weeks
|
|
Body fat mass
Time Frame: baseline and up to 4 weeks
|
Body fat mass will be measured using a calibrated digital scale via bioelectrical impedance analysis
|
baseline and up to 4 weeks
|
|
Systolic and diastolic blood pressure
Time Frame: baseline and up to 4 weeks
|
Systolic and diastolic blood pressure will be measured using a blood pressure monitor
|
baseline and up to 4 weeks
|
|
Heart rate
Time Frame: baseline and up to 4 weeks
|
Heart rate will be measured using a heart rate monitor
|
baseline and up to 4 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Sousana K Papadopoulou, International Hellenic University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Douligeris Study
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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