- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07402902
Caffeine Strategies and Fat Oxidation
Effects of Different Caffeine Ingestion Forms on Fat Oxidation During Cycle Ergometer Exercise
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.
Study Overview
Status
Conditions
Intervention / Treatment
- Drug: Caffeine (Guinama Anhydrous Powder)
- Other: Placebo (Cellulose Capsule)
- Dietary supplement: Caffeine (Nescafé Classic Coffee)
- Other: Placebo (Decaffeinated Coffee)
- Dietary supplement: Caffeine (Kafewake Gum)
- Other: Placebo (Non-caffeine Gum)
- Other: Caffeine Mouth Rinse Solution
- Other: Placebo Mouth Rinse Solution
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Madrid
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Fuenlabrada, Madrid, Spain, 28942
- Estadio Raúl González Blanco, Camino del Molino 5
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
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 informed consent
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
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.
|
3 mg/kg of anhydrous caffeine powder (Guinama, Spain) administered in an opaque capsule 60 min before exercise.
|
|
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.
|
Opaque capsule containing cellulose powder, matching caffeine capsules, taken 60 min before exercise.
|
|
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.
|
3 mg/kg of caffeine via Nescafé Classic (Nestlé, Switzerland) dissolved in 250 mL of water 60 min before exercise.
|
|
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.
|
Decaffeinated Nescafé (Nestlé, Switzerland) in 250 mL of water, matching caffeinated coffee, taken 60 min before.
|
|
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.
|
3 mg/kg of caffeine via Kafewake gum (Arafarma group, Spain), chewed for 10 min before exercise.
|
|
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.
|
Kafewake Non-caffeinated gum (Arafarma group, Spain) with identical taste and texture, chewed for 10 min before.
|
|
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.
|
3 mg/kg of caffeine (Nescafé Classic) dissolved in 25 mL of water for a 20-second rinse before exercise.
|
|
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.
|
Decaffeinated Nescafé in 25 mL of water for a 20-second rinse immediately before exercise.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Rate of fat oxidation during submaximal cycling exercise at Fatmax intensity
Time Frame: 1 hour per experimental session
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Rate of carbohydrate oxidation during submaximal cycling exercise at Fatmax intensity
Time Frame: 1 hour per experimental session
|
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).
|
1 hour per experimental session
|
|
Total energy expenditure during exercise
Time Frame: 1 hour per experimental session
|
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).
|
1 hour per experimental session
|
|
Mean Exercise Heart Rate
Time Frame: 1 hour per experimental session
|
Heart rate monitored continuously via a chest strap (Polar H9, Polar Electro, Findland) during the exercise test.
Unit of Measure: beats per minute (bpm).
|
1 hour per experimental session
|
|
Oxygen consumption
Time Frame: 1 hour per experimental session
|
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).
|
1 hour per experimental session
|
|
Carbon Dioxide Production
Time Frame: 1 hour per experimental session
|
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).
|
1 hour per experimental session
|
|
Blood lactate concentration
Time Frame: Every 20 minutes during each 1-hour session
|
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).
|
Every 20 minutes during each 1-hour session
|
|
Rating of Perceived Exertion (RPE) during exercise
Time Frame: Every 10 minutes during each 1-hour session
|
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).
|
Every 10 minutes during each 1-hour session
|
|
Occurrence of caffeine-related side effects
Time Frame: Immediately after each session and 24 hours post-exercise
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Structured questionnaire assessing symptoms commonly associated with caffeine intake, such as nervousness, tremors, insomnia, gastrointestinal discomfort, and increased heart rate.
|
Immediately after each session and 24 hours post-exercise
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Juan Del Coso, PhD, Universidad Rey Juan Carlos
- Principal Investigator: Arturo Casado, PhD, Universidad Rey Juan Carlos
Publications and helpful links
General 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Behavior
- Motor Activity
- Heterocyclic Compounds
- Heterocyclic Compounds, 2-Ring
- Heterocyclic Compounds, Fused-Ring
- Carbohydrates
- Alkaloids
- Purinones
- Purines
- Polymers
- Macromolecular Substances
- Biomedical and Dental Materials
- Manufactured Materials
- Technology, Industry, and Agriculture
- Polysaccharides
- Glucans
- Biopolymers
- Xanthines
- Caffeine
- Cellulose
Other Study ID Numbers
- URJC-CAF-FOX-2026
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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