- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04320446
Caffeine Increases Maximal Fat Oxidation During Exercise in Endurance-trained Men: is There a Diurnal Variation
Maximal fat oxidation during exercise (MFO) and the intensity of exercise that elicits MFO (Fatmax) has been recognized as potential determinants of endurance performance.
The purpose of this study was to determine the possible interaction between the effects of diurnal variation (morning vs. afternoon) and caffeine ingestion on MFO, Fatmax and VO2 max in endurance-trained men. Specifically, the investigators sought to elucidate whether the stimulant actions of caffeine could reverse the decrements of MFO and Fatmax observed in the morning.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Body weight, height, body composition (DXA), exercise test (MFO and VO2max assessment) will be measured during the 4 evaluations.
Participants were randomized into 4 exercise test conditions:
- Exercise test in the morning with placebo intake
- Exercise test in the evening with placebo intake
- Exercise test in the morning with caffeine intake
- Execrise test in the evening with caffeine intake
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Granada, Spain, 18016
- Instituto Mixto Universitario Deporte Salud
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Having a body mass index (BMI) ranged from 18.5 to 28 kg/m2
- not suffering any specific disease which can be aggravated by physical exercise
- having previous experience in endurance training (i.e. self-reporting at least 2 years of cycling or running training including more than 3 training sessions/week).
- Participant must be capable and willing to provide consent, understand exclusion criteria, instructions and protocols.
Exclusion Criteria:
- Being smoker
- Taking medication or drugs
- Any non-controlled medical condition which could influence results or could be worsened by the participation in the study
- Are deemed unsuitable by the investigator for any other reason, that prevent data collection.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Caffeine
A dose of 3 mg/kg of caffeine (i.e. a vegetable extraction from green coffee beans, Harrison Sport Nutrition®, Spain) was ingested before the beginning of each test.
|
The exercise test was performed between 8 a.m and 11 a.m
Other Names:
The exercise test was performed between 5 p.m. and 8 p.m.a
Other Names:
|
|
Placebo Comparator: Placebo
A dose of 3 mg/kg of placebo (i.e.
100% purity microcrystalline cellulose, Acofarma, Spain) was ingested before the beginning of each test.
|
The exercise test was performed between 8 a.m and 11 a.m
Other Names:
The exercise test was performed between 5 p.m. and 8 p.m.a
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
MFO
Time Frame: Through study completion, an average of 1 month
|
Maximal fat oxidation during exercise
|
Through study completion, an average of 1 month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
FATmax
Time Frame: Through study completion, an average of 1 month
|
The intensity of exercise that elicits MFO
|
Through study completion, an average of 1 month
|
|
VO2max
Time Frame: Through study completion, an average of 1 month
|
Cardiorrespiratory fitness measured by maximal oxygen uptake
|
Through study completion, an average of 1 month
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Jonatan Ruiz Ruiz, Dr., Universidad de Granada
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
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
Other Study ID Numbers
- Nº 507/CEIH/2018
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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