NCT06059911

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 15, 2022

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

September 15, 2023

Completed
14 days until next milestone

First Posted

Study publicly available on registry

September 29, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2023

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2024

Completed
Last Updated

October 3, 2023

Status Verified

September 1, 2023

Enrollment Period

1.5 years

First QC Date

September 15, 2023

Last Update Submit

September 30, 2023

Conditions

Outcome Measures

Primary Outcomes (15)

  • Countermovement jump height

    Jumping performance will be evaluated using a contact platform

    baseline and up to 4 weeks

  • 20 meters sprint running time

    Sprint performance will be evaluated using photocell gates

    baseline and up to 4 weeks

  • Rate of agility T-test performance

    Agility T-test will be evaluated using photocell gates

    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

    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

    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

    baseline and up to 4 weeks

  • Blood lactate concentartion

    Blood lactate concentration will be measured using a portable blood lactate analyzer

    baseline and up to 4 weeks

  • Creatine kinase concentration

    Creatine kinase activity will be measured on a clinical chemistry analyzer

    baseline and up to 4 weeks

  • Lactate dehydrogenase concentration

    Lactate dehydrogenase will be measured on a clinical chemistry analyzer

    baseline and up to 4 weeks

  • Alkaline phosphatase concentration

    Alkaline phosphatase will be measured on a clinical chemistry analyzer

    baseline and up to 4 weeks

  • Gamma-glutamyltransferase concentration

    Gamma-glutamyltransferase will be measured on a clinical chemistry analyzer

    baseline and up to 4 weeks

  • Urea concentration

    Urea will be measured on a clinical chemistry analyzer

    baseline and up to 4 weeks

  • Creatinine concentration

    Creatinine will be measured on a clinical chemistry analyzer

    baseline and up to 4 weeks

  • Serum glutamic-oxaloacetic transaminase activity

    Serum glutamic-oxaloacetic transaminase will be measured on a clinical chemistry analyzer

    baseline and up to 4 weeks

  • Serum glutamate-pyruvate transaminase activity

    Serum glutamate-pyruvate transaminase will be measured on a clinical chemistry analyzer

    baseline and up to 4 weeks

Secondary Outcomes (5)

  • Body mass

    baseline and up to 4 weeks

  • Body height

    baseline and up to 4 weeks

  • Body fat mass

    baseline and up to 4 weeks

  • Systolic and diastolic blood pressure

    baseline and up to 4 weeks

  • Heart rate

    baseline and up to 4 weeks

Study Arms (2)

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

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

Dietary Supplement: Placebo dietary supplement (97% maltodextrin)

Interventions

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

Multi-ingredient dietary supplement

Administration of an isoenergetic placebo comparator dietary supplement consisting of 97% maltodextrin

Placebo dietary supplement (97% maltodextrin)

Eligibility Criteria

Age18 Years - 41 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sports Nutrition Laboratory, International Hellenic University

Thessaloniki, Greece

Location

MeSH Terms

Interventions

CaffeineCreatinecitrulline malatemaltodextrin

Intervention Hierarchy (Ancestors)

XanthinesAlkaloidsHeterocyclic CompoundsPurinonesPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingGuanidinesAmidinesOrganic ChemicalsAmino AcidsAmino Acids, Peptides, and Proteins

Study Officials

  • Sousana K Papadopoulou

    International Hellenic University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 15, 2023

First Posted

September 29, 2023

Study Start

June 15, 2022

Primary Completion

December 15, 2023

Study Completion

June 15, 2024

Last Updated

October 3, 2023

Record last verified: 2023-09

Locations