NCT06610123

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 prolonged effects of caffeine on this type of exercise. Objectives: The present study aims to analyze the prolonged effects of caffeine intake on neuromuscular adaptations to resistance training 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
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

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
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2026

Completed
Last Updated

May 6, 2026

Status Verified

September 1, 2024

Enrollment Period

2.1 years

First QC Date

September 9, 2024

Last Update Submit

April 30, 2026

Conditions

Outcome Measures

Primary Outcomes (9)

  • Mean velocity at different %1RM

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

    Through study completion, an average of 12 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 12 weeks

  • Mean power output at different %1RM

    Measuring during bench press and back squat exercises.

    Through study completion, an average of 12 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 12 weeks

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

    In bench press and back squat exercises

    Through study completion, an average of 12 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 12 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 12 weeks

  • Resting Metabolic Rate (RMR)

    Kcal at rest using a metabolic chart.

    Through study completion, an average of 12 weeks

  • Maximal Fat Oxidation Rate (MFO)

    g/min (MFO) using a metabolic chart.

    Through study completion, an average of 12 weeks

Secondary Outcomes (6)

  • Fat-free mass

    Through study completion, an average of 4 weeks

  • Fat mass

    Through study completion, an average of 12 weeks

  • Physical activity (METs-min/wk)

    Through study completion, an average of 12 weeks

  • Dietary (g/kg of macronutrients)

    Through study completion, an average of 12 weeks

  • Mood state

    Through study completion, an average of 12 weeks

  • +1 more secondary outcomes

Study Arms (8)

Genotype AA - Male - Caffeine

EXPERIMENTAL
Dietary Supplement: Caffeine and Resistance training

Genotype AC or CC - Male - Caffeine

EXPERIMENTAL
Dietary Supplement: Caffeine and Resistance training

Genotype AA - Male - Placebo

PLACEBO COMPARATOR
Dietary Supplement: Placebo and Resistance training

Genotype AC or CC - Male - Placebo

PLACEBO COMPARATOR
Dietary Supplement: Placebo and Resistance training

Genotype AA - Female - Caffeine

EXPERIMENTAL
Dietary Supplement: Caffeine and Resistance training

Genotype AC or CC - Female - Caffeine

EXPERIMENTAL
Dietary Supplement: Caffeine and Resistance training

Genotype AA - Female - Placebo

PLACEBO COMPARATOR
Dietary Supplement: Placebo and Resistance training

Genotype AC or CC - Female - Placebo

PLACEBO COMPARATOR
Dietary Supplement: Placebo and Resistance training

Interventions

Acute caffeine intake (3 mg/kg) prior each resistance training session of a 8 weeks training program.

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

Acute placebo intake (3 mg/kg of maltodextrin) prior each resistance training session of a 8 weeks training program.

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) lowe 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 (1)

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

Alcalá de Henares, Madrid, 28805, Spain

Location

MeSH Terms

Interventions

CaffeineResistance Training

Intervention Hierarchy (Ancestors)

XanthinesAlkaloidsHeterocyclic CompoundsPurinonesPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingExercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPhysical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
Statistician
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL 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

April 30, 2026

Study Completion

April 30, 2026

Last Updated

May 6, 2026

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will share

Locations