HealthyNCT02985606
How Does Altering the Timing of Pre-exercise Low-dose Caffeine Ingestion Affect Endurance Exercise Performance
A study testing Caffeine powder -60, Caffeine powder -30 and Caffeine powder 0 in people with Healthy, run by University of Exeter at 1 site in United Kingdom.
Trial summary
Investigate how manipulating the time between caffeine ingestion and exercise may alter exercise performance and cognition Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Caffeine powder -60, Caffeine powder -30 and Caffeine powder 0
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 14 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Nov 2016to 15 Sep 2018
- 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
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- vo2max > 55 ml/kg/min
- females on contraceptive pill
Who cannot join
- recent skeletal muscle injury
- cardiovascular injury
- metabolic disease
Trial locations and contacts
1 site in 1 country.
About this study
Investigate how manipulating the time between caffeine ingestion and exercise may alter exercise performance and cognition
- Conditions
- Healthy
- Being tested
- Caffeine powder -60, Caffeine powder -30, Caffeine powder 0, Placebo powder -60, Placebo powder -30
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Caffeine powder -60Other
Caffeine powder -30Other
Caffeine powder 0Other
Placebo powder -60Other
Placebo powder -30Other
Placebo powder 0Other
| Study group | Role | What they receive |
|---|---|---|
| Caffeine -60 | Active comparator | Caffeine at 60 minutes prior to time trial Receives: Other: Caffeine powder -60; Other: Placebo powder -30; Other: Placebo powder 0 |
| Caffeine -30 | Active comparator | Caffeine at 30 minutes prior to time trial Receives: Other: Caffeine powder -30; Other: Placebo powder -60; Other: Placebo powder 0 |
| Caffeine 0 | Active comparator | Caffeine immediately prior to time trial Receives: Other: Caffeine powder 0; Other: Placebo powder -60; Other: Placebo powder -30 |
| Placebo | Placebo comparator | Placebo drink at all time points Receives: Other: Placebo powder -60; Other: Placebo powder -30; Other: Placebo powder 0 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Work done in kilojoules (kJ) during a 15 minute time trial on a cycle ergometer
Measured: 15 minutes
Secondary outcomes (4)
Whole body fuel substrate utilisation measured using indirect calorimetry
Measured: 10 minutes
Change in plasma caffeine concentration and metabolites
Measured: 2 hours 45 minutes
Change in cognitive function measured using stroop test
Measured: 2 hours 45 minutes
Collection of saliva for genotyping of CYP1A2
Measured: 30 mintes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2016 (estimated)
- Study startNov 2016
- Primary completion30 Jun 2017
- Study completion15 Sep 2018
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 HealthyStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Exeter
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02985606
- Sponsor's protocol ID
- 181739/02
- Status last verified
- Oct 2018
- First submitted
- 30 Nov 2016
- Last updated
- 16 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Davenport AD, Jameson TSO, Kilroe SP, Monteyne AJ, Pavis GF, Wall BT, Dirks ML, Alamdari N, Mikus CR, Stephens FB. A Randomised, Placebo-Controlled, Crossover Study Investigating the Optimal Timing of a Caffeine-Containing Supplement for Exercise Performance. Sports Med Open. 2020 Mar 30;6(1):17. doi: 10.1186/s40798-020-00246-x.
PubMed 32232597
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- How Does Altering the Timing of Pre-exercise Low-dose Caffeine Ingestion Affect Endurance Exercise Performance
- ClinicalTrials.gov ID
- NCT02985606
- Acronym / sponsor ID
- 181739/02
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- University of ExeterUniversity, hospital or other
- Study start
- Nov 2016
- Primary completion
- 30 Jun 2017 (actual)
- Study completion
- 15 Sep 2018 (actual)
- First posted
- 7 Dec 2016 (estimated)
- 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.
Investigate how manipulating the time between caffeine ingestion and exercise may alter exercise performance and cognition
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Caffeine -60 | Active comparator | Other: Caffeine powder -60, Other: Placebo powder -30, Other: Placebo powder 0Caffeine at 60 minutes prior to time trial |
| Caffeine -30 | Active comparator | Other: Caffeine powder -30, Other: Placebo powder -60, Other: Placebo powder 0Caffeine at 30 minutes prior to time trial |
| Caffeine 0 | Active comparator | Other: Caffeine powder 0, Other: Placebo powder -60, Other: Placebo powder -30Caffeine immediately prior to time trial |
| Placebo | Placebo comparator | Other: Placebo powder -60, Other: Placebo powder -30, Other: Placebo powder 0Placebo drink at all time points |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- vo2max > 55 ml/kg/min
- females on contraceptive pill
Key exclusion criteria (3 listed)
- recent skeletal muscle injury
- cardiovascular injury
- metabolic disease
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 |
|---|---|---|
| Caffeine powder -60 | Other | Caffeine -60 |
| Caffeine powder -30 | Other | Caffeine -30 |
| Caffeine powder 0 | Other | Caffeine 0 |
| Placebo powder -60 | Other | Caffeine -30, Caffeine 0, Placebo |
| Placebo powder -30 | Other | Caffeine -60, Caffeine 0, Placebo |
| Placebo powder 0 | Other | Caffeine -30, Caffeine -60, Placebo |
Primary outcome
Work done in kilojoules (kJ) during a 15 minute time trial on a cycle ergometer
Time frame: 15 minutes
4 secondary outcomes
Whole body fuel substrate utilisation measured using indirect calorimetry
Time frame: 10 minutes
Change in plasma caffeine concentration and metabolites
Time frame: 2 hours 45 minutes
Change in cognitive function measured using stroop test
Time frame: 2 hours 45 minutes
Collection of saliva for genotyping of CYP1A2
Time frame: 30 mintes
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 16 Oct 2018.
- Derived from this study: PubMed 32232597Davenport AD, Jameson TSO, Kilroe SP, Monteyne AJ, Pavis GF, Wall BT, Dirks ML, Alamdari N, Mikus CR, Stephens FB. A Randomised, Placebo-Controlled, Crossover Study Investigating the Optimal Timing of a Caffeine-Containing Supplement for Exercise Performance. Sports Med Open. 2020 Mar 30;6(1):17. doi: 10.1186/s40798-020-00246-x.
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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 Caffeine powder -60, Caffeine powder -30 and Caffeine powder 0 in people with Healthy, run by University of Exeter at 1 site in United Kingdom.
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 2 inclusion and 3 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 16 Oct 2018. 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 United Kingdom. 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?
Work done in kilojoules (kJ) during a 15 minute time trial on a cycle ergometer (time frame: 15 minutes). 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 NCT02985606, 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 16 Oct 2018.