Caffeine and Endurance PerformanceAPEXNCT05641454
The Effect of a Peat and Apple Extract on Muscle ATP and Exercise Performance
A study testing ElevATP supplement in people with Caffeine and Endurance Performance, run by University of Exeter at 1 site in United Kingdom.
Trial summary
A study to test the hypothesis that a combined peat and apple extract will increase blood and muscle ATP, which will increase cycling performance 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
- Caffeine and Endurance Performance
- What is being tested?
- ElevATP supplement
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 17 Oct 2022to 15 Feb 2023
- 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
- Age 18 - 40
- Healthy
- Recreationally active (i.e. Participants will be deemed as too trained if they are defined as participating in structured resistance exercise 3 or more times per week for >6 months or participating in structured endurance exercise for >6h per week for >6 months. Participants will be defined as too sedentary if they do not exceed the governments guidelines of 150 / 75 min per week of light / heavy exercise.)
Who cannot join
- Allergy to Lidocaine
- Any diagnosed metabolic health condition
- Pregnant
- Non-habitual caffeine intake
- Smoker
- Diagnosed Cardiovascular disease
- Beta-Blockers
- Recent history of musculoskeletal injury
Trial locations and contacts
1 site in 1 country.
About this study
A study to test the hypothesis that a combined peat and apple extract will increase blood and muscle ATP, which will increase cycling performance
- Conditions
- Caffeine and Endurance Performance
- Being tested
- ElevATP supplement, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ElevATP supplementDietary supplement
ElevATP supplement containing apple and ancient peat extract
PlaceboDietary supplement
Maltodextrin placebo
| Study group | Role | What they receive |
|---|---|---|
| ElevATP supplement | Experimental | Not described Receives: Dietary Supplement: ElevATP supplement |
| Maltodextrin placebo | Placebo comparator | Not described Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle ATP concentration
Concentration of ATP in skeletal muscle tissue (mmol/kg dry weight)
Measured: 4 hours
Secondary outcomes (10)
Total work performed during exercise
Work performed during glycogen depleting exercise on a cycle ergometer (J)
Measured: 2 hours
Blood ATP concentration
Concentration of ATP in blood (mmol/L)
Measured: 4 hours
Substrate oxidation
Substrate oxidation over 1 h steady state cycle (g/min)
Measured: 1 hour
Blood glucose concentration
Concentration of glucose in blood (mmol/L)
Measured: 4 hours
Blood lactate concentration
Concentration of lactate in blood (mmol/L)
Measured: 4 hours
Muscle glycogen
Muscle glycogen concentration in skeletal muscle tissue (mmol/kg dry weight)
Measured: 4 hours
Muscle ADP concentration
Concentration of muscle metabolites
Measured: 4 hours (mmol/kg dry weight)
Muscle ATP concentration
Concentration of muscle metabolites
Measured: 4 hours (mmol/kg dry weight)
Muscle creatine concentration
Concentration of muscle metabolites
Measured: 4 hours (mmol/kg dry weight)
Muscle phosphocreatine concentration
Concentration of muscle metabolites
Measured: 4 hours (mmol/kg dry weight)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2022
- Study start17 Oct 2022
- Primary completion15 Feb 2023
- Study completion15 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Caffeine and Endurance PerformanceStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Exeter
- Sponsor type
- University, hospital or other
- Collaborators
- VDF FutureCeuticals Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05641454
- Sponsor's protocol ID
- 516252
- Acronym
- APEX
- Status last verified
- Mar 2023
- First submitted
- 1 Nov 2022
- Last updated
- 22 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of a Peat and Apple Extract on Muscle ATP and Exercise Performance
- ClinicalTrials.gov ID
- NCT05641454
- Acronym / sponsor ID
- APEX / 516252
- Conditions
- Caffeine and Endurance Performance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of ExeterUniversity, hospital or other
- Collaborators
- VDF FutureCeuticals Inc.
- Study start
- 17 Oct 2022 (actual)
- Primary completion
- 15 Feb 2023 (actual)
- Study completion
- 15 Feb 2023 (actual)
- First posted
- 7 Dec 2022 (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.
A study to test the hypothesis that a combined peat and apple extract will increase blood and muscle ATP, which will increase cycling performance
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ElevATP supplement | Experimental | Dietary Supplement: ElevATP supplement |
| Maltodextrin placebo | Placebo comparator | Dietary Supplement: Placebo |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age 18 - 40
- Healthy
- Recreationally active (i.e. Participants will be deemed as too trained if they are defined as participating in structured resistance exercise 3 or more times per week for >6 months or participating in structured endurance exercise for >6h per week for >6 months. Participants will be defined as too sedentary if they do not exceed the governments guidelines of 150 / 75 min per week of light / heavy exercise.)
Key exclusion criteria (8 listed)
- Allergy to Lidocaine
- Any diagnosed metabolic health condition
- Pregnant
- Non-habitual caffeine intake
- Smoker
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 |
|---|---|---|
| ElevATP supplementElevATP supplement containing apple and ancient peat extract | Dietary supplement | ElevATP supplement |
| PlaceboMaltodextrin placebo | Dietary supplement | Maltodextrin placebo |
Primary outcome
Muscle ATP concentration
Time frame: 4 hours
Concentration of ATP in skeletal muscle tissue (mmol/kg dry weight)
10 secondary outcomes
Total work performed during exercise
Time frame: 2 hours
Blood ATP concentration
Time frame: 4 hours
Substrate oxidation
Time frame: 1 hour
Blood glucose concentration
Time frame: 4 hours
Blood lactate concentration
Time frame: 4 hours
Muscle glycogen
Time frame: 4 hours
Muscle ADP concentration
Time frame: 4 hours (mmol/kg dry weight)
Muscle ATP concentration
Time frame: 4 hours (mmol/kg dry weight)
Muscle creatine concentration
Time frame: 4 hours (mmol/kg dry weight)
Muscle phosphocreatine concentration
Time frame: 4 hours (mmol/kg dry weight)
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 22 Mar 2023.
- Individual participant dataSharing planned: No
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 ElevATP supplement in people with Caffeine and Endurance Performance, 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 3 inclusion and 8 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 22 Mar 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 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?
Muscle ATP concentration (time frame: 4 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Mar 2023.