NCT06618261

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, little is known about the prolonged effects of this supplement on neuromuscular adaptations to strength training. Objectives: The present study aims to analyze the effects of acute and chronic caffeine intake on neuromuscular adaptations to strength training, according to sex (men vs. women) and type of exercise (bench press vs. squat), as well as fatigue perception, mood state, and potential side effects in older adults.

Trial Health

75
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
3mo left

Started Jan 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

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 Progress91%
Jan 2024Jul 2026

Study Start

First participant enrolled

January 14, 2024

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

September 9, 2024

Completed
22 days until next milestone

First Posted

Study publicly available on registry

October 1, 2024

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2026

Last Updated

May 6, 2026

Status Verified

April 1, 2026

Enrollment Period

2.5 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 (RMR) 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 mass

    Through study completion, an average of 12 weeks

  • Fat-free 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 (4)

Caffeine - Males

EXPERIMENTAL
Dietary Supplement: Caffeine + Resistance exercise

Placebo - Males

PLACEBO COMPARATOR
Dietary Supplement: Placebo + Resistance exercise

Caffeine - Females

EXPERIMENTAL
Dietary Supplement: Caffeine + Resistance exercise

Placebo - Females

PLACEBO COMPARATOR
Dietary Supplement: Placebo + Resistance exercise

Interventions

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

Caffeine - FemalesCaffeine - Males

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

Placebo - FemalesPlacebo - Males

Eligibility Criteria

Age55 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age between ≥ 55
  • Body mass index (BMI) ≥ 30 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.
  • 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, 28805, 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
PARALLEL
Model Details: Randomized controlled trial
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 9, 2024

First Posted

October 1, 2024

Study Start

January 14, 2024

Primary Completion (Estimated)

July 30, 2026

Study Completion (Estimated)

July 30, 2026

Last Updated

May 6, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will share

Locations