Dietary SupplementCIRCAF_WOMNCT05880186
Influence of the Time of Day in the Effect of Caffeine on Maximal Fat Oxidation During Exercise in Women
A study testing Acute caffeine supplementation in people with Dietary Supplement, run by Universidad Francisco de Vitoria at 1 site in Spain.
Trial summary
Caffeine is a natural stimulant with well-recognized metabolic benefits, however, there is a lack of studies investigating the time-of-day caffeine influence to enhance fat oxidation in women. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Dietary Supplement
- What is being tested?
- Acute caffeine supplementation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 14 participants
- Where
- 1 siteSpain
- Study dates
- 9 Feb 2021to 9 Apr 2021
- 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
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- To be non-smokers.
- To have low caffeine intake (i.e., < 50 mg of caffeine per day in the previous 2 months)
- To show no previous history of cardiopulmonary diseases or having suffered musculoskeletal injuries in the previous 6 months.
- To have a regular duration of their menstrual cycle for the previous 6 months.
- To confirm no existence of any type of menstrual disorders such as dysmenorrhea, amenorrhea, or strong symptoms associated with pre-menstrual syndrome.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Influence of the Time of Day in the Effect of Caffeine on Maximal Fat Oxidation During Exercise in Women. A Randomized, Crossover, Double-blind, and Placebo-controlled Study
Caffeine is a natural stimulant with well-recognized metabolic benefits, however, there is a lack of studies investigating the time-of-day caffeine influence to enhance fat oxidation in women. The aim of this study was to evaluate the influence of the time of the day on the effect of caffeine on maximal rate of fat oxidation during aerobic exercise in women.
Read the detailed description
Caffeine is a natural stimulant with well-recognized sports performance benefits. Aside its performance-enhancing effect, caffeine has the potential of increasing fat utilization during aerobic exercise at submaximal intensities, lowering-down the contribution of carbohydrate as a fuel. This property of caffeine may provoke a glycogen-sparing effect in the skeletal muscle and liver for exercise situations where carbohydrate availability may be a challenge. Additionally, the capacity of caffeine to enhance fat utilization during exercise could be of interest for improving health outcomes as it may increase the rate of change in body composition in exercise programs. Maximal fat oxidation rate (MFO) during exercise is a remarkable physiological indicator associated with metabolic flexibility/body weight loss and endurance performance To date, it is unknown if caffeine increases MFO in the same proportion during morning and evening exercise trials in women. For this reason, the aim of the present study was to evaluate the influence of the time of the day on the effect of caffeine on MFO in women. We hypothesised that caffeine would increase MFO during morning and evening exercise and this effect would be of similar magnitude at both times of day.
- Conditions
- Dietary Supplement
- Being tested
- Acute caffeine supplementation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acute caffeine supplementationDietary supplement
To evaluate the influence of the time of the day (i.e., morning vs evening) on the effect of caffeine on maximal fat oxidation in women.
| Study group | Role | What they receive |
|---|---|---|
| Caffeine intake | Experimental | Test in the morning
A dose of 3 mg/kg of caffeine (Bulk Powders, Essex, United Kingdom) was ingested before the beginning of each test.
Test in the evening
A dose of 3 mg/kg of caffeine (Bulk Powders, Essex, United Kingdom) was ingested before the beginning of each test. Receives: Dietary Supplement: Acute caffeine supplementation |
| Placebo intake | Placebo comparator | Test in the morning
A dose of 3 mg/kg of placebo (Cellulose, Guinama, Valencia, Spain) was ingested before the beginning of each test.
Test in the evening
A dose of 3 mg/kg of placebo (Cellulose, Guinama, Valencia, Spain) was ingested before the beginning of each test Receives: Dietary Supplement: Acute caffeine supplementation |
What is being measured
The primary outcome is the main question the study is designed to answer.
MFO
Maximal fat oxidation during exercise
Measured: 2-months
Secondary outcomes (3)
FATmax
The intensity of exercise that elicits MFO
Measured: 2-months
RPE
Rate of percevied exertion during exercise
Measured: 2-months
FAT AND CHO oxidation
Fat and carbohydrates oxidation
Measured: 2-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2023
- Study start9 Feb 2021
- Primary completion9 Apr 2021
- Study completion9 Apr 2021
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 Dietary SupplementStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Dietary Supplement: caffeine acute supplementation
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Francisco de Vitoria
- Sponsor type
- University, hospital or other
- Collaborators
- Universidad de Granada, Universidad Rey Juan Carlos, Camilo Jose Cela University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05880186
- Sponsor's protocol ID
- UFVitoria_2
- Acronym
- CIRCAF_WOM
- Status last verified
- May 2023
- First submitted
- 18 May 2023
- Last updated
- 30 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Munoz A, Aguilar-Navarro M, Ruiz-Moreno C, Varillas-Delgado D, Amaro-Gahete FJ, Gutierrez-Hellin J, Del Coso J, Lopez-Samanes A. Influence of the time of day in the effect of caffeine on maximal fat oxidation during exercise in women: a randomized, crossover, double-blind, and placebo-controlled study. Eur J Appl Physiol. 2024 Mar;124(3):849-859. doi: 10.1007/s00421-023-05312-2. Epub 2023 Sep 20.
PubMed 37728787
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of the Time of Day in the Effect of Caffeine on Maximal Fat Oxidation During Exercise in Women. A Randomized, Crossover, Double-blind, and Placebo-controlled Study
- ClinicalTrials.gov ID
- NCT05880186
- Acronym / sponsor ID
- CIRCAF_WOM / UFVitoria_2
- Conditions
- Dietary Supplement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Universidad Francisco de VitoriaUniversity, hospital or other
- Collaborators
- Universidad de Granada, Universidad Rey Juan Carlos, Camilo Jose Cela University
- Study start
- 9 Feb 2021 (actual)
- Primary completion
- 9 Apr 2021 (actual)
- Study completion
- 9 Apr 2021 (actual)
- First posted
- 30 May 2023 (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.
Caffeine is a natural stimulant with well-recognized metabolic benefits, however, there is a lack of studies investigating the time-of-day caffeine influence to enhance fat oxidation in women. The aim of this study was to evaluate the influence of the time of the day on the effect of caffeine on maximal rate of fat oxidation during aerobic exercise in women.
Detailed description
Caffeine is a natural stimulant with well-recognized sports performance benefits. Aside its performance-enhancing effect, caffeine has the potential of increasing fat utilization during aerobic exercise at submaximal intensities, lowering-down the contribution of carbohydrate as a fuel. This property of caffeine may provoke a glycogen-sparing effect in the skeletal muscle and liver for exercise situations where carbohydrate availability may be a challenge. Additionally, the capacity of caffeine to enhance fat utilization during exercise could be of interest for improving health outcomes as it may increase the rate of change in body composition in exercise programs. Maximal fat oxidation rate (MFO) during exercise is a remarkable physiological indicator associated with metabolic flexibility/body weight loss and endurance performance To date, it is unknown if caffeine increases MFO in the same proportion during morning and evening exercise trials in women. For this reason, the aim of the present study was to evaluate the influence of the time of the day on the effect of caffeine on MFO in women. We hypothesised that caffeine would increase MFO during morning and evening exercise and this effect would be of similar magnitude at both times of day.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Dietary Supplement: caffeine acute supplementation
| Arm | Type | Receives |
|---|---|---|
| Caffeine intake | Experimental | Dietary Supplement: Acute caffeine supplementationTest in the morning A dose of 3 mg/kg of caffeine (Bulk Powders, Essex, United Kingdom) was ingested before the beginning of each test. Test in the evening A dose of 3 mg/kg of caffeine (Bulk Powders, Essex, United Kingdom) was ingested before the beginning of each test. |
| Placebo intake | Placebo comparator | Dietary Supplement: Acute caffeine supplementationTest in the morning A dose of 3 mg/kg of placebo (Cellulose, Guinama, Valencia, Spain) was ingested before the beginning of each test. Test in the evening A dose of 3 mg/kg of placebo (Cellulose, Guinama, Valencia, Spain) was ingested before the beginning of each test |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- To be non-smokers.
- To have low caffeine intake (i.e., < 50 mg of caffeine per day in the previous 2 months)
- To show no previous history of cardiopulmonary diseases or having suffered musculoskeletal injuries in the previous 6 months.
- To have a regular duration of their menstrual cycle for the previous 6 months.
- To confirm no existence of any type of menstrual disorders such as dysmenorrhea, amenorrhea, or strong symptoms associated with pre-menstrual syndrome.
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Acute caffeine supplementationTo evaluate the influence of the time of the day (i.e., morning vs evening) on the effect of caffeine on maximal fat oxidation in women. | Dietary supplement | Caffeine intake, Placebo intake |
Primary outcome
MFO
Time frame: 2-months
Maximal fat oxidation during exercise
3 secondary outcomes
FATmax
Time frame: 2-months
RPE
Time frame: 2-months
FAT AND CHO oxidation
Time frame: 2-months
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 30 May 2023.
- Derived from this study: PubMed 37728787Munoz A, Aguilar-Navarro M, Ruiz-Moreno C, Varillas-Delgado D, Amaro-Gahete FJ, Gutierrez-Hellin J, Del Coso J, Lopez-Samanes A. Influence of the time of day in the effect of caffeine on maximal fat oxidation during exercise in women: a randomized, crossover, double-blind, and placebo-controlled study. Eur J Appl Physiol. 2024 Mar;124(3):849-859. doi: 10.1007/s00421-023-05312-2. Epub 2023 Sep 20.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acute caffeine supplementation in people with Dietary Supplement, run by Universidad Francisco de Vitoria 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 5 inclusion and 1 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 30 May 2023. 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: 2-months). 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 NCT05880186, 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 30 May 2023.