HealthyNCT05354999
Effects of Combinations of Performance-enhancing Supplements on Exercise Performance
A study testing Sodium bicarbonate and caffeine in people with Healthy, run by Morten Hostrup, PhD at 1 site in Denmark.
Trial summary
The purpose of the study is to investigate the effect of combinations of creatine monohydrate, sodium bicarbonate and caffeine on exercise performance and fatigability. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Sodium bicarbonate and caffeine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 23 participants
- Where
- 1 siteDenmark
- Study dates
- 18 Apr 2022to Dec 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy
- VO2max of >50 ml/min/kg for men and >45 ml/min/kg for women
- Performs endurance training >3 times per week
Who cannot join
- Chronic disease deemed by the study responsible medical doctor to interfere with any part of the study
- Smoking
- Chronic use of prescription medicine deemed by the study responsible medical doctor to interfere with any part of the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Different Combinations of Performance-enhancing Supplements on High Intensity Exercise Performance
The purpose of the study is to investigate the effect of combinations of creatine monohydrate, sodium bicarbonate and caffeine on exercise performance and fatigability.
- Conditions
- Healthy
- Being tested
- Sodium bicarbonate and caffeine
- Keywords
- Exercise, Performance, Supplementation
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sodium bicarbonate and caffeineDietary supplement
On experimental days subjects ingest a combination of sodium bicarbonate, caffeine and placebo.
| Study group | Role | What they receive |
|---|---|---|
| Creatine | Experimental | Subjects ingest creatine monohydrate daily. Receives: Dietary Supplement: Sodium bicarbonate and caffeine |
| Placebo | Placebo comparator | Subjects ingest placebo daily. Receives: Dietary Supplement: Sodium bicarbonate and caffeine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Work performed (kJ/Watt)
Work performed during a 6 minute time trial
Measured: Measured at each trial throughout the study, on average 4 weeks
Secondary outcomes (2)
Work performed (kJ/Watt)
Work performed during a 15 second sprint test
Measured: Measured at each trial throughout the study, on average 4 weeks
Muscle strength (Nm)
Maximal voluntary isometric contraction of m. quadriceps femoris
Measured: Measured at each trial throughout the study, on average 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2022
- Study start18 Apr 2022
- Primary completionMar 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Morten Hostrup, PhD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Morten Hostrup, PhD, University of Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05354999
- Sponsor's protocol ID
- COCKTAIL
- Status last verified
- Aug 2022
- First submitted
- 18 Apr 2022
- Last updated
- 12 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Different Combinations of Performance-enhancing Supplements on High Intensity Exercise Performance
- ClinicalTrials.gov ID
- NCT05354999
- Acronym / sponsor ID
- COCKTAIL
- Conditions
- Healthy
- Keywords
- Exercise, Performance, Supplementation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Morten Hostrup, PhDUniversity, hospital or other
- Study start
- 18 Apr 2022 (actual)
- Primary completion
- Mar 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 2 May 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.
The purpose of the study is to investigate the effect of combinations of creatine monohydrate, sodium bicarbonate and caffeine on exercise performance and fatigability.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Creatine | Experimental | Dietary Supplement: Sodium bicarbonate and caffeineSubjects ingest creatine monohydrate daily. |
| Placebo | Placebo comparator | Dietary Supplement: Sodium bicarbonate and caffeineSubjects ingest placebo daily. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy
- VO2max of >50 ml/min/kg for men and >45 ml/min/kg for women
- Performs endurance training >3 times per week
Key exclusion criteria (3 listed)
- Chronic disease deemed by the study responsible medical doctor to interfere with any part of the study
- Smoking
- Chronic use of prescription medicine deemed by the study responsible medical doctor to interfere with any part of the study
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 |
|---|---|---|
| Sodium bicarbonate and caffeineOn experimental days subjects ingest a combination of sodium bicarbonate, caffeine and placebo. | Dietary supplement | Creatine, Placebo |
Primary outcome
Work performed (kJ/Watt)
Time frame: Measured at each trial throughout the study, on average 4 weeks
Work performed during a 6 minute time trial
2 secondary outcomes
Work performed (kJ/Watt)
Time frame: Measured at each trial throughout the study, on average 4 weeks
Muscle strength (Nm)
Time frame: Measured at each trial throughout the study, on average 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2022.
- Individual participant dataSharing planned: Undecided
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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 Sodium bicarbonate and caffeine in people with Healthy, run by Morten Hostrup, PhD at 1 site in Denmark.
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 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: status not confirmed, as of the sponsor's last update on 12 Aug 2022. 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 Denmark. 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?
Results are not available in the source record.
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 performed (kJ/Watt) (time frame: Measured at each trial throughout the study, on average 4 weeks). 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 12 Aug 2022.