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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT06059911
Other study ID # Douligeris Study
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date June 15, 2022
Est. completion date June 15, 2024

Study information

Verified date September 2023
Source University of Thessaly
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 36
Est. completion date June 15, 2024
Est. primary completion date December 15, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 41 Years
Eligibility 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, ß-alanine, citrulline malate or BCAA-protein supplementation at least six months before the initiation of the study

Study Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
Multi-ingredient dietary supplement (caffeine, creatine monohydrate, ß-alanine, citrulline malate, BCAA)
Administration of a multi-ingredient dietary supplement consisting of 200 mg caffeine, 3.3 g creatine monohydrate, 3.2 g ß-alanine, 6 g citrulline malate and 5 g branched chain amino acids
Placebo dietary supplement (97% maltodextrin)
Administration of an isoenergetic placebo comparator dietary supplement consisting of 97% maltodextrin

Locations

Country Name City State
Greece Sports Nutrition Laboratory, International Hellenic University Thessaloníki

Sponsors (1)

Lead Sponsor Collaborator
Athanasios Z. Jamurtas

Country where clinical trial is conducted

Greece, 

Outcome

Type Measure Description Time frame Safety issue
Primary Countermovement jump height Jumping performance will be evaluated using a contact platform baseline and up to 4 weeks
Primary 20 meters sprint running time Sprint performance will be evaluated using photocell gates baseline and up to 4 weeks
Primary Rate of agility T-test performance Agility T-test will be evaluated using photocell gates baseline and up to 4 weeks
Primary Rate of running-based anaerobic sprint test performance Running-based anaerobic sprint test performance will be evaluated using photocell gates baseline and up to 4 weeks
Primary 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 baseline and up to 4 weeks
Primary 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 baseline and up to 4 weeks
Primary Blood lactate concentartion Blood lactate concentration will be measured using a portable blood lactate analyzer baseline and up to 4 weeks
Primary Creatine kinase concentration Creatine kinase activity will be measured on a clinical chemistry analyzer baseline and up to 4 weeks
Primary Lactate dehydrogenase concentration Lactate dehydrogenase will be measured on a clinical chemistry analyzer baseline and up to 4 weeks
Primary Alkaline phosphatase concentration Alkaline phosphatase will be measured on a clinical chemistry analyzer baseline and up to 4 weeks
Primary Gamma-glutamyltransferase concentration Gamma-glutamyltransferase will be measured on a clinical chemistry analyzer baseline and up to 4 weeks
Primary Urea concentration Urea will be measured on a clinical chemistry analyzer baseline and up to 4 weeks
Primary Creatinine concentration Creatinine will be measured on a clinical chemistry analyzer baseline and up to 4 weeks
Primary Serum glutamic-oxaloacetic transaminase activity Serum glutamic-oxaloacetic transaminase will be measured on a clinical chemistry analyzer baseline and up to 4 weeks
Primary Serum glutamate-pyruvate transaminase activity Serum glutamate-pyruvate transaminase will be measured on a clinical chemistry analyzer baseline and up to 4 weeks
Secondary Body mass Body mass will be measured using a calibrated digital scale baseline and up to 4 weeks
Secondary Body height Body height will be measured using a stadiometer baseline and up to 4 weeks
Secondary Body fat mass Body fat mass will be measured using a calibrated digital scale via bioelectrical impedance analysis baseline and up to 4 weeks
Secondary Systolic and diastolic blood pressure Systolic and diastolic blood pressure will be measured using a blood pressure monitor baseline and up to 4 weeks
Secondary Heart rate Heart rate will be measured using a heart rate monitor baseline and up to 4 weeks
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