Clinical trial NCT06059911: Pre-workout Supplementation and Basketball
Official title: The Effect of a Pre-workout Supplement on Basketball-specific Performance and Biochemical Profile of Well-trained Athletes
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Sport Performance
Lead sponsor: University of Thessaly
Sponsor class: OTHER
First posted: 2023-09-29
Enrollment: 36
Sex: MALE
Minimum age (years): 18
Maximum age (years): 41
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

1. Male participants, 18-41 years old
2. Absence of drugs, abuse or medications, which are known to affect the Shooting, sprinting, jumping, agility, anaerobic and endurance performance
3. Consent to follow a regular dietary plan for basketball players

Exclusion Criteria:

1. Restraining orthopedic/neuromuscular problems
2. Caffeine hypersensitivity
3. Consumption of more than three servings of coffee per day
4. Use of any supplement or steroids prior to the study
5. Use of creatine, β-alanine, citrulline malate or BCAA-protein supplementation at least six months before the initiation of the study

Primary outcomes:
measure: Countermovement jump height
timeFrame: baseline and up to 4 weeks
measure: 20 meters sprint running time
timeFrame: baseline and up to 4 weeks
measure: Rate of agility T-test performance
timeFrame: baseline and up to 4 weeks
measure: Rate of running-based anaerobic sprint test performance
timeFrame: baseline and up to 4 weeks
measure: Rate of Yo-Yo intermittent recovery test level 1 test performance
timeFrame: baseline and up to 4 weeks
measure: Rate of basketball-specific shooting performance
timeFrame: baseline and up to 4 weeks
measure: Blood lactate concentartion
timeFrame: baseline and up to 4 weeks
measure: Creatine kinase concentration
timeFrame: baseline and up to 4 weeks
measure: Lactate dehydrogenase concentration
timeFrame: baseline and up to 4 weeks
measure: Alkaline phosphatase concentration
timeFrame: baseline and up to 4 weeks
measure: Gamma-glutamyltransferase concentration
timeFrame: baseline and up to 4 weeks
measure: Urea concentration
timeFrame: baseline and up to 4 weeks
measure: Creatinine concentration
timeFrame: baseline and up to 4 weeks
measure: Serum glutamic-oxaloacetic transaminase activity
timeFrame: baseline and up to 4 weeks
measure: Serum glutamate-pyruvate transaminase activity
timeFrame: baseline and up to 4 weeks
Secondary outcomes:
measure: Body mass
timeFrame: baseline and up to 4 weeks
measure: Body height
timeFrame: baseline and up to 4 weeks
measure: Body fat mass
timeFrame: baseline and up to 4 weeks
measure: Systolic and diastolic blood pressure
timeFrame: baseline and up to 4 weeks
measure: Heart rate
timeFrame: baseline and up to 4 weeks
Other outcomes:
Locations:
city: Thessaloníki
country: Greece
facility: Sports Nutrition Laboratory, International Hellenic University
Study officials:
affiliation: International Hellenic University
name: Sousana K Papadopoulou
role: STUDY_DIRECTOR
References: