Effects of Caffeine and L-Theanine on Physical and Cognitive Performance in Trained Athletes

NCT ID: NCT07268573

Last Updated: 2025-12-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-01
• Study Completion Date: 2025-08-14

Brief Summary

The aim of this clinical trial is to examine how caffeine and L-theanine, taken alone or together, affect both physical and cognitive performance in healthy, trained athletes. The study aims to answer whether these commonly consumed dietary ingredients can enhance strength, endurance, and hand-eye coordination under controlled laboratory conditions.

Researchers will compare four supplementation conditions:

Caffeine (CAF) - 3 mg per kilogram of body weight L-Theanine (THE) - 200 mg Combined Caffeine and L-Theanine (COM) - same doses together Placebo (CON) - mannitol (inactive substance) Each participant will complete all four test sessions in a randomized, double-blind, crossover design, with at least 72 hours between sessions. Capsules will be taken 60 minutes before testing to allow time for absorption. During each session, participants will perform a series of physical and cognitive tasks, including maximal isometric strength tests, an intermittent endurance test, and a computerized eye-hand coordination task.

The main hypothesis is that caffeine and L-theanine, alone or in combination, will improve strength and cognitive coordination compared with placebo. All participants are healthy competitive athletes between 18 and 30 years old. The study is conducted under standardized laboratory and indoor sports-hall conditions, with ethics approval obtained from the Sinop University Human Research Ethics Committee (Approval No. 2025/337).

Detailed Description

This randomized, double-blind, placebo-controlled, crossover clinical trial investigates the acute effects of caffeine (CAF), L-theanine (THE), their combination (COM), and placebo (CON) supplementation on physical and cognitive performance in young, healthy, competitive athletes. Each participant completed all four experimental conditions in randomized order, separated by a minimum 72-hour washout period to minimize carryover effects. The randomization sequence was computer-generated by an independent researcher, and both participants and assessors were blinded to all conditions.

A total of 20 trained athletes (12 males, 8 females; 19.9 ± 2.4 years) participated. All were actively engaged in team or individual sports at a competitive level, with no history of cardiovascular, neurological, or musculoskeletal disorders, and no known intolerance to caffeine, theanine, or placebo components. Anthropometric and body composition data were collected using standardized procedures, including multi-frequency bioelectrical impedance analysis. Participants maintained normal caffeine consumption habits to preserve ecological validity and avoid withdrawal effects.

The supplementation protocol consisted of four conditions: (1) 3 mg/kg anhydrous caffeine, (2) 200 mg L-theanine, (3) a combination of both, and (4) placebo (mannitol). All supplements were encapsulated in visually identical gelatin capsules, and participants ingested five capsules with water 60 minutes before testing. Testing sessions were conducted at 09:00 a.m. to minimize circadian variability. Participants abstained from alcohol, strenuous exercise, and dietary supplements for 24 hours before each session, and replicated their pre-trial dietary intake based on 24-hour dietary logs.

All testing sessions were performed under standardized indoor laboratory conditions (22 ± 1 °C, 50 ± 5% humidity). The test sequence was fixed as eye-hand coordination, maximal isometric strength, and intermittent aerobic endurance, with adequate rest intervals between tests.

Primary outcomes included:

Maximal isometric strength, measured via handgrip, back, and leg dynamometry (Lafayette, Japan).

Intermittent aerobic endurance, assessed using the Yo-Yo Intermittent Endurance Test Level 1.

Eye-hand coordination, evaluated using a computerized test battery (EHC) that quantified accuracy, speed, and precision parameters.

A priori power analysis (f = 0.25, α = 0.05, 1-β = 0.80) determined a required sample size of 16 participants; 20 were recruited to allow for potential attrition. All 20 completed the study.

The study protocol was approved by the Sinop University Human Research Ethics Committee (Approval No. 2025/337), and written informed consent was obtained from all participants.

This trial aims to clarify whether acute ingestion of caffeine, L-theanine, or their combination exerts differential or synergistic effects on physical strength, endurance, and coordination in trained athletes, thereby contributing to the understanding of combined ergogenic aids in sports performance.

Conditions

Cognitive Performance; Physical Performance Enhancement; Caffeine and L-theanine Interaction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: QUADRUPLE

Study Groups

Caffeine Supplementation (CAF)

Participants receive 3 mg of anhydrous caffeine per kilogram of body weight, encapsulated in gelatin capsules identical in appearance to other conditions. Capsules are ingested with water 60 minutes before testing.

Group Type: EXPERIMENTAL

Caffeine

Intervention Type: DIETARY_SUPPLEMENT

Participants receive 3 mg of anhydrous caffeine per kilogram of body weight, encapsulated in identical gelatin capsules (five in total). Capsules are taken orally with water 60 minutes before testing. The caffeine powder (98.5% purity, Oxford Vitality Health Co., UK) is administered once per experimental session, with at least 72 hours between conditions.

L-Theanine Supplementation (THE)

Participants receive 200 mg of L-theanine (pure L-theanine powder, Orzax Pharmaceuticals, Istanbul, Turkey), encapsulated in gelatin capsules identical in appearance to other conditions. Capsules are ingested with water 60 minutes before testing.

Group Type: EXPERIMENTAL

L-theanine

Intervention Type: DIETARY_SUPPLEMENT

Participants receive a single 200 mg dose of L-theanine (Orzax Pharmaceuticals, Istanbul, Turkey; active ingredient manufactured in Germany) encapsulated in identical gelatin capsules. The supplement is ingested orally with water 60 minutes before testing. All testing sessions are separated by at least 72 hours.

Combined Caffeine and L-Theanine (COM)

Participants receive a combination of 3 mg/kg anhydrous caffeine and 200 mg L-theanine, encapsulated together in identical gelatin capsules. Capsules are taken 60 minutes before testing to assess potential synergistic effects on physical and cognitive performance.

Group Type: EXPERIMENTAL

Combined Caffeine and L-Theanine

Intervention Type: DIETARY_SUPPLEMENT

Participants receive a combination of 3 mg/kg anhydrous caffeine and 200 mg L-theanine, encapsulated together in visually identical gelatin capsules. The mixture is taken orally with water 60 minutes before testing to assess potential synergistic effects on performance. Each participant completes all four supplementation conditions in randomized order, separated by ≥72 hours.

Placebo (CON)

Participants receive placebo capsules filled with mannitol, a non-nutritive sugar alcohol with no known ergogenic properties. Capsules are identical in size, color, texture, and weight to the active supplement conditions and are ingested 60 minutes before testing.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

Participants receive placebo capsules filled with mannitol, a non-nutritive sugar alcohol with no known ergogenic or ergolytic effects. Capsules are identical in appearance, weight, and texture to the active supplement capsules and are taken orally with water 60 minutes before testing.

Interventions

Caffeine

Participants receive 3 mg of anhydrous caffeine per kilogram of body weight, encapsulated in identical gelatin capsules (five in total). Capsules are taken orally with water 60 minutes before testing. The caffeine powder (98.5% purity, Oxford Vitality Health Co., UK) is administered once per experimental session, with at least 72 hours between conditions.

Intervention Type: DIETARY_SUPPLEMENT

L-theanine

Participants receive a single 200 mg dose of L-theanine (Orzax Pharmaceuticals, Istanbul, Turkey; active ingredient manufactured in Germany) encapsulated in identical gelatin capsules. The supplement is ingested orally with water 60 minutes before testing. All testing sessions are separated by at least 72 hours.

Intervention Type: DIETARY_SUPPLEMENT

Combined Caffeine and L-Theanine

Participants receive a combination of 3 mg/kg anhydrous caffeine and 200 mg L-theanine, encapsulated together in visually identical gelatin capsules. The mixture is taken orally with water 60 minutes before testing to assess potential synergistic effects on performance. Each participant completes all four supplementation conditions in randomized order, separated by ≥72 hours.

Intervention Type: DIETARY_SUPPLEMENT

Placebo

Participants receive placebo capsules filled with mannitol, a non-nutritive sugar alcohol with no known ergogenic or ergolytic effects. Capsules are identical in appearance, weight, and texture to the active supplement capsules and are taken orally with water 60 minutes before testing.

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

• Active participation in individual or team sports at a competitive level
• Age between [insert range, e.g., 18-30] years
• Absence of any known medical or metabolic disorder

Exclusion Criteria

• History of cardiovascular, neurological, or musculoskeletal disorders within the past 12 months
• Known intolerance or hypersensitivity to caffeine or theanine
• Allergy to mannitol or other excipients used in capsule formulation
• Current use of prescription medications
• Physician-directed restriction of caffeine or theanine consumption.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Ulaş Can YILDIRIM

OTHER

Sponsor Role: lead

Responsible Party

Ulaş Can YILDIRIM

Assoc. Prof.

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Sinop University Facility

Sinop, Centarl, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

2025/337

Identifier Type: -

Identifier Source: org_study_id