NCT06610110

Brief Summary

Introduction: Several studies have evaluated and confirmed the ergogenic effect of acute caffeine intake on sports performance, specifically on strength and power performance. However, it remains to be elucidated how CYP1A2 polymorphism influences the acute effects of caffeine on this type of exercise. Objectives: The present study aims to analyze the effects of acute caffeine intake on muscular strength, power, and endurance performance according to CYP1A2 polymorphism in men and women.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2024

Geographic Reach
1 country

2 active sites

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2024

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

September 9, 2024

Completed
15 days until next milestone

First Posted

Study publicly available on registry

September 24, 2024

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2025

Completed
Last Updated

May 6, 2026

Status Verified

August 1, 2025

Enrollment Period

1.3 years

First QC Date

September 9, 2024

Last Update Submit

April 30, 2026

Conditions

Outcome Measures

Primary Outcomes (10)

  • cyp1a2 polymorphism

    Using saliva sample and PCR

    Before the beginning of the trial

  • Mean velocity at different %1RM

    Measuring bar mean velocity desplacement during bench press and back squat exercises.

    Through study completion, an average of 2 weeks

  • Peak velocity at different %1RM

    Measuring bar peak velocity and time to reach peak velocity of bar desplacement during bench press and back squat exercises.

    Through study completion, an average of 2 weeks

  • Mean power output at different %1RM

    Measuring during bench press and back squat exercises.

    Through study completion, an average of 2 weeks

  • Peak power output and time to reach peak power output at different %1RM

    Measuring during bench press and back squat exercises.

    Through study completion, an average of 2 weeks

  • Number of repetitions performed in 1 set at 65%1RM until task failure

    In bench press and back squat exercises

    Through study completion, an average of 2 weeks

  • Bar velocity deplacement performed in 1 set at 65%1RM until task failure

    In bench press and back squat exercises

    Through study completion, an average of 2 weeks

  • Power output generated in 1 set at 65%1RM until task failure

    In bench press and back squat exercise

    Through study completion, an average of 2 weeks

  • Maximal Fat Oxidation Rate (MFO)

    g/min (MFO) using a metabolic chart.

    Through study completion, an average of 2 weeks

  • Resting Metabolic Rate (RMR)

    Kcal at rest (RMR) using a metabolic chart.

    Through study completion, an average of 2 weeks

Secondary Outcomes (5)

  • Mood state (tension, depression, anger, vigor, fatigue and confusion)

    Through study completion, an average of 2 weeks

  • Adverse effects

    Through study completion, an average of 2 weeks

  • handgrip and isometric mid-thigh pull tests

    Through study completion, an average of 2 weeks

  • Vertical Jump (cm)

    Through study completion, an average of 2 weeks

  • Vertical Jump (power)

    Through study completion, an average of 2 weeks

Study Arms (8)

Genotype AA - Male - Caffeine

EXPERIMENTAL
Dietary Supplement: Caffeine

Genotype AC or CC - Male - Caffeine

EXPERIMENTAL
Dietary Supplement: Caffeine

Genotype AA - Male - Placebo

PLACEBO COMPARATOR
Dietary Supplement: Placebo

Genotype AC or CC - Male - Placebo

PLACEBO COMPARATOR
Dietary Supplement: Placebo

Genotype AA - Female - Caffeine

EXPERIMENTAL
Dietary Supplement: Caffeine

Genotype AC or CC - Female - Caffeine

EXPERIMENTAL
Dietary Supplement: Caffeine

Genotype AA - Female - Placebo

PLACEBO COMPARATOR
Dietary Supplement: Placebo

Genotype AC or CC - Female - Placebo

PLACEBO COMPARATOR
Dietary Supplement: Placebo

Interventions

CaffeineDIETARY_SUPPLEMENT

Acute caffeine intake (3 mg/kg)

Genotype AA - Female - CaffeineGenotype AA - Male - CaffeineGenotype AC or CC - Female - CaffeineGenotype AC or CC - Male - Caffeine
PlaceboDIETARY_SUPPLEMENT

Placebo (3 mg/kg maltodextrin)

Genotype AA - Female - PlaceboGenotype AA - Male - PlaceboGenotype AC or CC - Female - PlaceboGenotype AC or CC - Male - Placebo

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Age between ≥ 18 and ≤ 35 years.
  • Body mass index (BMI) lower than 25 kg/m².
  • Physically active subjects (≥150 min/week of moderate exercise).
  • Healthy men and women without neurological, cardiometabolic, immunological, or physical conditions that prevent them from performing physical exercise.
  • Participants capable of performing the tests.

You may not qualify if:

  • History of neuromuscular, cardiac, or diseases that could affect liver or muscle metabolism.
  • Use of drugs or other stimulants that interfere with caffeine intake and intestinal absorption during the tests and study.
  • Body mass index (BMI) ≥ 25 kg/m².
  • Having undergone prolonged periods of forced physical inactivity during the 6 months prior to the study.
  • Performing strenuous exercise within 48 hours prior to the tests.
  • Failing to replicate the same food intake on the two experimental days.
  • Consuming caffeine after 6 PM on the day prior to training or testing.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Facultad de Medicina y Ciencias de la Salud. Universidad de Alcalá

Alcalá de Henares, Madrid, 28805, Spain

Location

Facultad de Medicina y Ciencias de la Salud. Universidad de Alcalá

Alcalá de Henares, Madrid, Spain

Location

MeSH Terms

Interventions

Caffeine

Intervention Hierarchy (Ancestors)

XanthinesAlkaloidsHeterocyclic CompoundsPurinonesPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 9, 2024

First Posted

September 24, 2024

Study Start

April 1, 2024

Primary Completion

July 30, 2025

Study Completion

July 30, 2025

Last Updated

May 6, 2026

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will share

Locations