Energy MetabolismNCT04320446
Caffeine Increases Maximal Fat Oxidation During Exercise in Endurance-trained Men: is There a Diurnal Variation
A study testing Test in the morning and Test in the afternoon in people with Energy Metabolism and Athletic Performance, run by Universidad de Granada at 1 site in Spain.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Energy Metabolism, Athletic Performance
- What is being tested?
- Test in the morning and Test in the afternoon
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jun 2019to 30 Nov 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Conditions
- Energy Metabolism, Athletic Performance
- Being tested
- Test in the morning, Test in the afternoon
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Test in the morningBehavioural
Also called MFO-morning, Fatmax-morning, and VO2max-morning
The exercise test was performed between 8 a.m and 11 a.m
Test in the afternoonBehavioural
Also called (MFO-afternoon, Fatmax-afternoon, and VO2max-afternoon
The exercise test was performed between 5 p.m. and 8 p.m.a
| Study group | Role | What they receive |
|---|---|---|
| Caffeine | Experimental | 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. Receives: Behavioral: Test in the morning; Behavioral: Test in the afternoon |
| Placebo | Placebo comparator | A dose of 3 mg/kg of placebo (i.e. 100% purity microcrystalline cellulose, Acofarma, Spain) was ingested before the beginning of each test. Receives: Behavioral: Test in the morning; Behavioral: Test in the afternoon |
What is being measured
The primary outcome is the main question the study is designed to answer.
MFO
Maximal fat oxidation during exercise
Measured: Through study completion, an average of 1 month
Secondary outcomes (2)
FATmax
The intensity of exercise that elicits MFO
Measured: Through study completion, an average of 1 month
VO2max
Cardiorrespiratory fitness measured by maximal oxygen uptake
Measured: Through study completion, an average of 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2020
- Study start1 Jun 2019
- Primary completion30 Nov 2019
- Study completion30 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Energy MetabolismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad de Granada
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jonatan Ruiz Ruiz, Universidad de Granada
- Investigators
- Jonatan Ruiz Ruiz, Dr., Principal investigator, Universidad de Granada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04320446
- Sponsor's protocol ID
- Nº 507/CEIH/2018
- Status last verified
- Mar 2020
- First submitted
- 19 Mar 2020
- Last updated
- 25 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ramirez-Maldonado M, Jurado-Fasoli L, Del Coso J, R Ruiz J, Amaro-Gahete FJ. Caffeine increases maximal fat oxidation during a graded exercise test: is there a diurnal variation? J Int Soc Sports Nutr. 2021 Jan 7;18(1):5. doi: 10.1186/s12970-020-00400-6.
PubMed 33413459
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Caffeine Increases Maximal Fat Oxidation During Exercise in Endurance-trained Men: is There a Diurnal Variation
- ClinicalTrials.gov ID
- NCT04320446
- Acronym / sponsor ID
- Nº 507/CEIH/2018
- Conditions
- Energy Metabolism, Athletic Performance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Universidad de GranadaUniversity, hospital or other
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- 30 Nov 2019 (actual)
- Study completion
- 30 Nov 2019 (actual)
- First posted
- 25 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Caffeine | Experimental | Behavioral: Test in the morning, Behavioral: Test in the afternoonA 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. |
| Placebo | Placebo comparator | Behavioral: Test in the morning, Behavioral: Test in the afternoonA dose of 3 mg/kg of placebo (i.e. 100% purity microcrystalline cellulose, Acofarma, Spain) was ingested before the beginning of each test. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Test in the morningAlso: MFO-morning, Fatmax-morning, and VO2max-morningThe exercise test was performed between 8 a.m and 11 a.m | Behavioural | Caffeine, Placebo |
| Test in the afternoonAlso: (MFO-afternoon, Fatmax-afternoon, and VO2max-afternoonThe exercise test was performed between 5 p.m. and 8 p.m.a | Behavioural | Caffeine, Placebo |
Primary outcome
MFO
Time frame: Through study completion, an average of 1 month
Maximal fat oxidation during exercise
2 secondary outcomes
FATmax
Time frame: Through study completion, an average of 1 month
VO2max
Time frame: Through study completion, an average of 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2020.
- Derived from this study: PubMed 33413459Ramirez-Maldonado M, Jurado-Fasoli L, Del Coso J, R Ruiz J, Amaro-Gahete FJ. Caffeine increases maximal fat oxidation during a graded exercise test: is there a diurnal variation? J Int Soc Sports Nutr. 2021 Jan 7;18(1):5. doi: 10.1186/s12970-020-00400-6.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jonatan Ruiz Ruiz, Dr. principal investigator
Universidad de Granada
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Test in the morning and Test in the afternoon in people with Energy Metabolism and Athletic Performance, run by Universidad de Granada at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MFO (time frame: Through study completion, an average of 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04320446, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2020.