NCT07402902

Brief Summary

The goal of this clinical trial is to learn if different forms of caffeine ingestion can influence fat oxidation during submaximal cycling exercise. The study will recruit healthy adults, both men and women, aged 18 to 50, who regularly perform aerobic exercise. The main questions it aims to answer are:

  • Does caffeine increase fat oxidation during one hour of cycling at the Fatmax intensity?
  • Do different forms of caffeine ingestion (capsule, coffee, chewing gum, or mouth rinse) differ in their effect on fat oxidation?
  • Do these caffeine forms alter total energy expenditure, cardiorespiratory response, or perceived exertion during exercise?
  • Are there differences in the occurrence or severity of side effects between caffeine administration methods? Researchers will compare each caffeine form to its corresponding placebo to determine their effects on fat oxidation and other physiological outcomes. Participants will:
  • Attend a pre-experimental session to determine their Fatmax intensity and VO₂max using an incremental cycling test
  • Perform eight experimental sessions, each consisting of one hour of cycling at Fatmax intensity
  • Receive caffeine or placebo via capsules, coffee, chewing gum, or mouth rinse according to a randomized, double-blind, crossover design
  • Be monitored for fat and carbohydrate oxidation, total energy expenditure, heart rate, and perceived exertion during exercise
  • Report any side effects immediately after the session and 24 hours later using a structured questionnaire All sessions will be conducted under controlled laboratory conditions with standardized protocols to ensure safety and reliable measurements.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
5mo left

Started Mar 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

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 Progress27%
Mar 2026Sep 2026

First Submitted

Initial submission to the registry

January 13, 2026

Completed
29 days until next milestone

First Posted

Study publicly available on registry

February 11, 2026

Completed
1 month until next milestone

Study Start

First participant enrolled

March 15, 2026

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2026

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2026

Last Updated

April 29, 2026

Status Verified

February 1, 2026

Enrollment Period

5 months

First QC Date

January 13, 2026

Last Update Submit

April 28, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Rate of fat oxidation during submaximal cycling exercise at Fatmax intensity

    Continuous measurement of fat oxidation using indirect calorimetry during 1-hour cycling at Fatmax intensity. Calculated from respiratory gas exchange (VO₂ and VCO₂) using Frayn's equations. Unit of Measure: grams per minute (g/min).

    1 hour per experimental session

Secondary Outcomes (8)

  • Rate of carbohydrate oxidation during submaximal cycling exercise at Fatmax intensity

    1 hour per experimental session

  • Total energy expenditure during exercise

    1 hour per experimental session

  • Mean Exercise Heart Rate

    1 hour per experimental session

  • Oxygen consumption

    1 hour per experimental session

  • Carbon Dioxide Production

    1 hour per experimental session

  • +3 more secondary outcomes

Study Arms (8)

Caffeine capsule

EXPERIMENTAL

Participants will ingest 3 mg/kg of anhydrous caffeine powder in an opaque capsule 60 minutes before performing 60 minutes of cycling on a cycle ergometer at Fatmax intensity.

Drug: Caffeine (Guinama Anhydrous Powder)

Placebo capsule

PLACEBO COMPARATOR

Participants will ingest an opaque capsule filled with cellulose (placebo) 60 minutes before performing 60 minutes of cycling on a cycle ergometer at Fatmax intensity.

Other: Placebo (Cellulose Capsule)

Caffeine coffee

EXPERIMENTAL

Participants will consume 3 mg/kg of caffeine via soluble coffee (Nescafé Classic) in 250 mL of hot water 60 minutes before performing 60 minutes of cycling on a cycle ergometer at Fatmax intensity.

Dietary Supplement: Caffeine (Nescafé Classic Coffee)

Placebo coffee

PLACEBO COMPARATOR

Participants will consume decaffeinated soluble coffee (Nescafé Descafeinado) in 250 mL of hot water 60 minutes before performing 60 minutes of cycling on a cycle ergometer at Fatmax intensity.

Other: Placebo (Decaffeinated Coffee)

Caffeine chewing gum

EXPERIMENTAL

Participants will chew caffeinated gum (Kafewake) containing 3 mg/kg of caffeine for 10 minutes before performing 60 minutes of cycling on a cycle ergometer at Fatmax intensity.

Dietary Supplement: Caffeine (Kafewake Gum)

Placebo chewing gum

PLACEBO COMPARATOR

Participants will chew non-caffeinated gum (Kafewake) with identical flavor and texture for 10 minutes before performing 60 minutes of cycling on a cycle ergometer at Fatmax intensity.

Other: Placebo (Non-caffeine Gum)

Caffeine mouth rinse

EXPERIMENTAL

Participants will perform a 20-second mouth rinse with 25 mL of water containing 3 mg/kg of caffeine from soluble coffee (Nescafé Classic) before performing 60 minutes of cycling on a cycle ergometer at Fatmax intensity.

Other: Caffeine Mouth Rinse Solution

Placebo mouth rinse

PLACEBO COMPARATOR

Participants will perform a 20-second mouth rinse with 25 mL of water containing decaffeinated soluble coffee (Nescafé descafeinado) before performing 60 minutes of cycling on a cycle ergometer at Fatmax intensity.

Other: Placebo Mouth Rinse Solution

Interventions

3 mg/kg of anhydrous caffeine powder (Guinama, Spain) administered in an opaque capsule 60 min before exercise.

Caffeine capsule

3 mg/kg of caffeine via Nescafé Classic (Nestlé, Switzerland) dissolved in 250 mL of water 60 min before exercise.

Caffeine coffee
Caffeine (Kafewake Gum)DIETARY_SUPPLEMENT

3 mg/kg of caffeine via Kafewake gum (Arafarma group, Spain), chewed for 10 min before exercise.

Caffeine chewing gum

3 mg/kg of caffeine (Nescafé Classic) dissolved in 25 mL of water for a 20-second rinse before exercise.

Caffeine mouth rinse

Opaque capsule containing cellulose powder, matching caffeine capsules, taken 60 min before exercise.

Placebo capsule

Decaffeinated Nescafé (Nestlé, Switzerland) in 250 mL of water, matching caffeinated coffee, taken 60 min before.

Placebo coffee

Kafewake Non-caffeinated gum (Arafarma group, Spain) with identical taste and texture, chewed for 10 min before.

Placebo chewing gum

Decaffeinated Nescafé in 25 mL of water for a 20-second rinse immediately before exercise.

Placebo mouth rinse

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy men and women aged 18-50 years
  • Regular aerobic exercise at least 1 hour per day, 2 days per week
  • Provide written informed consent

You may not qualify if:

  • Smoking
  • Use of medication or ergogenic supplements during the study period
  • Caffeine intolerance or allergy
  • Cardiopulmonary or musculoskeletal disorders
  • Use of oral contraceptives in female participants

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Estadio Raúl González Blanco, Camino del Molino 5

Fuenlabrada, Madrid, 28942, Spain

Location

Related Publications (2)

  • Guest NS, VanDusseldorp TA, Nelson MT, Grgic J, Schoenfeld BJ, Jenkins NDM, Arent SM, Antonio J, Stout JR, Trexler ET, Smith-Ryan AE, Goldstein ER, Kalman DS, Campbell BI. International society of sports nutrition position stand: caffeine and exercise performance. J Int Soc Sports Nutr. 2021 Jan 2;18(1):1. doi: 10.1186/s12970-020-00383-4.

  • Ruiz-Moreno C, Gutierrez-Hellin J, Amaro-Gahete FJ, Gonzalez-Garcia J, Giraldez-Costas V, Perez-Garcia V, Del Coso J. Caffeine increases whole-body fat oxidation during 1 h of cycling at Fatmax. Eur J Nutr. 2021 Jun;60(4):2077-2085. doi: 10.1007/s00394-020-02393-z. Epub 2020 Oct 6.

MeSH Terms

Conditions

Motor Activity

Interventions

CaffeineCellulose

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

XanthinesAlkaloidsHeterocyclic CompoundsPurinonesPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingGlucansBiopolymersPolymersMacromolecular SubstancesPolysaccharidesCarbohydratesBiomedical and Dental MaterialsManufactured MaterialsTechnology, Industry, and Agriculture

Study Officials

  • Juan Del Coso, PhD

    Universidad Rey Juan Carlos

    PRINCIPAL INVESTIGATOR
  • Arturo Casado, PhD

    Universidad Rey Juan Carlos

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Model Details: Participants will undergo all experimental conditions (caffeine via capsule, coffee, chewing gum, and mouth rinse, and their corresponding placebos) in a randomized, double-blind, counterbalanced crossover design.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 13, 2026

First Posted

February 11, 2026

Study Start

March 15, 2026

Primary Completion (Estimated)

July 31, 2026

Study Completion (Estimated)

September 30, 2026

Last Updated

April 29, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will share

De-identified individual participant data underlying the results reported in publications may be made available upon reasonable request. These data may include anonymized metabolic, ventilatory, cardiovascular and perceptual variables collected during the study (e.g., fat oxidation rate, energy expenditure, VO₂, VCO₂, heart rate, capillary blood lactate concentration, and ratings of perceived exertion). Any data sharing will be subject to ethical approval, compliance with applicable data protection regulations, and approval by the study investigators.

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
De-identified individual participant data may be shared after the publication of the main study findings and will remain available for up to three years following publication.
Access Criteria
Access to any de-identified individual participant data will be considered on a case-by-case basis. Requests will require a scientifically sound proposal and may be subject to additional ethical review and data use agreements, in accordance with institutional and legal requirements. The study investigators reserve the right to decline requests.
More information

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