ClinicalTrials.gg
Enrolling by invitationNCT07402902Updated Apr 29, 2026

Caffeine Strategies and Fat Oxidation

An interventional study of Caffeine (Guinama Anhydrous Powder) and Caffeine (Nescafé Classic Coffee) in Fat Metabolism, Caffeine and Cycling, sponsored by Universidad Rey Juan Carlos. Enrolling by invitation at 1 site in Spain. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-04-29.

Sponsored by Universidad Rey Juan Carlos · Not applicable, Interventional, and Basic science

From the registry’s dates

  • Primary completion was expected by Jul 2026, 3 months ago, but the record still lists the study as enrolling by invitation.
Phase
Not applicable
Study type
Interventional
Enrollment
10
Allocation
Randomized
Ages
18 Years to 50 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 13 studies testing caffeine in Motor Activity — 2 open to participants now, 2 under way, none of them phase 3. Caffeine · Motor Activity.

Planned enrollment
12th of 13
10 · median 23
Started
2026
the only one that year
No phase
11 of 13
2 open now
Registered
10th of 13
by date

Among the 13 studies testing caffeine in Motor Activity, this one is the 12th largest by planned enrollment, is the only one that started in 2026, is one of 11 with no phase, and was the 10th registered.

By phase

13 studies; the count open now beside each. This study's row is marked.

No phasethis study11 · 2 open
Phase 12 · 0 open

By the year they started

First in 2010; this study’s year is marked. 1 started in 2026.

Size and results

Median enrollment 23 across the 13 interventional studies. Of the 10 that completed or were terminated, 0 (0%) have results posted.

Was this useful?
Watch this landscapeDownload CSVWith an account: a weekly mail of what changed among 13 studies testing caffeine in Motor Activity, or all of them as a file.
02

Study 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.

03

Conditions studied

  • Fat Metabolism
  • Caffeine
  • Cycling
  • Exercise
  • Ergogenics

Browse trials for

04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Smoking
  • Use of medication or ergogenic supplements during the study period
  • Caffeine intolerance or allergy
  • Cardiopulmonary or musculoskeletal disorders
  • Use of oral in female participants
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double (Participant, Investigator)
Enrollment
10 participants (estimated)

Study arms

  • Experimental
    Caffeine capsule

    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 comparator
    Placebo capsule

    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)

  • Experimental
    Caffeine coffee

    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 comparator
    Placebo coffee

    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)

  • Experimental
    Caffeine chewing gum

    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 comparator
    Placebo chewing gum

    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)

  • Experimental
    Caffeine mouth rinse

    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 comparator
    Placebo mouth rinse

    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.

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

  • Dietary supplementCaffeine (Kafewake Gum)

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

  • OtherCaffeine Mouth Rinse Solution

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

  • OtherPlacebo (Cellulose Capsule)

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

  • OtherPlacebo (Decaffeinated Coffee)

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

  • OtherPlacebo (Non-caffeine Gum)

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

  • OtherPlacebo Mouth Rinse Solution

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

06

What researchers measure

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).

    Time frame: 1 hour per experimental session

Secondary outcomes

  1. Rate of carbohydrate oxidation during submaximal cycling exercise at Fatmax intensity

    Continuous measurement of carbohydrate 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).

    Time frame: 1 hour per experimental session

  2. Total energy expenditure during exercise

    Estimated from indirect calorimetry data using Brouwer's equation, recorded continuously during 1-hour cycling at Fatmax intensity. Unit of Measure: kilocalories per minute (kcal/min).

    Time frame: 1 hour per experimental session

  3. Mean Exercise Heart Rate

    Heart rate monitored continuously via a chest strap (Polar H9, Polar Electro, Findland) during the exercise test. Unit of Measure: beats per minute (bpm).

    Time frame: 1 hour per experimental session

  4. Oxygen consumption

    Volume of oxygen consumed during the exercise session measured breath-by-breath via indirect calorimetry using the Ergostik gas analyzer (Geratherm Respiratory GmbH, Germany). Unit of Measure: Liters per minute (L/min).

    Time frame: 1 hour per experimental session

  5. Carbon Dioxide Production

    Volume of carbon dioxide produced during the exercise session measured breath-by-breath via indirect calorimetry using the Ergostik gas analyzer (Geratherm Respiratory GmbH, Germany). Unit of Measure: Liters per minute (L/min).

    Time frame: 1 hour per experimental session

  6. Blood lactate concentration

    Measured from capillary blood samples taken from the fingertip during exercise to assess metabolic response to different caffeine interventions. Unit of measure: Millimoles per liter (mmol/L).

    Time frame: Every 20 minutes during each 1-hour session

  7. Rating of Perceived Exertion (RPE) during exercise

    Assessed using Borg's 6-20 scale; participants report perceived exertion at regular intervals. Unit of Measure: Units on a scale (from 6 to 20).

    Time frame: Every 10 minutes during each 1-hour session

  8. Occurrence of caffeine-related side effects

    Structured questionnaire assessing symptoms commonly associated with caffeine intake, such as nervousness, tremors, insomnia, gastrointestinal discomfort, and increased heart rate.

    Time frame: Immediately after each session and 24 hours post-exercise

07

Study locations

1 site
  • Estadio Raúl González Blanco, Camino del Molino 5
    Fuenlabrada, Madrid 28942, Spain
08

References and documents

Publications

  • 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. PubMed 33388079 ↗
  • 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. PubMed 33025051 ↗

Individual participant data

Plan to share: Yes — 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.

Supporting information: Study protocol, Statistical analysis plan, Informed consent form

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.

Data sharing details ↗ · www.urjc.es

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Mar 2026 (actual). Primary completion is estimated for Jul 2026, 4 months after the start.

Of 5,147 non-industry interventional studies with no phase under Motor Activity, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 36. This study's planned 4 months is below that.

Counting every sponsor, half of 5,207 studies reached it within 17 months; a quarter within 7 and three quarters within 36.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 13, 2026
First posted
Feb 11, 2026
StartActual
Mar 15, 2026
Primary completionEst.
Jul 31, 2026
CompletionEst.
Sep 30, 2026
Last update
Apr 29, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 29, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07402902
Responsible party
Daniel Trujillo-Colmena (Principal Investigator, Universidad Rey Juan Carlos) — Principal investigator
First posted
Feb 11, 2026
Start date
Mar 15, 2026
Primary completion
Jul 31, 2026 (estimated)
Completion
Sep 30, 2026 (estimated)
Last update
Apr 29, 2026

Study contacts

Juan Del Coso, PhD
principal investigator · Universidad Rey Juan Carlos
Arturo Casado, PhD
principal investigator · Universidad Rey Juan Carlos

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Studies of the drug tested here: Caffeine

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