Healthy VolunteersMIPSNCT05230862
Does a Multi-ingredient Pre-workout Supplement Enhance Cycling Time Trial Performance?
A study testing Ladder Supplement in people with Healthy Volunteers, run by University of Exeter at 1 site in United Kingdom.
Trial summary
The aim of the present study is to test the effect of ingesting a multi-ingredient pre- exercise supplement containing caffeine, creatine, beta-alanine and L-Citrulline compared to a placebo, on endurance exercise performance. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Ladder Supplement
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 2 Dec 2021to 30 Sep 2022
- 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
- Age 18-40
- Healthy
- Highly trained endurance athletes (V̇O2max: males >55 and females >50 mL⋅kg bm-1⋅min-1)
- Both males and females are allowed to participate. If females are on the oral contraceptive pill they are to be tested on consecutive weeks. If they are not on the oral contraceptive pill, then female subjects are to be tested every 4 weeks, at the same point of their menstrual cycle.
Who cannot join
- Any diagnosed metabolic health condition
- Pregnant
- Non-habitual caffeine intake
- Smoker
- No endurance training
- Diagnosed Cardiovascular disease
- Recent history of musculoskeletal injury
- Anti-depressant and anti-anxiety medication
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Does a Multi-ingredient Pre-workout Supplement Enhance Cycling Time Trial
The aim of the present study is to test the effect of ingesting a multi-ingredient pre- exercise supplement containing caffeine, creatine, beta-alanine and L-Citrulline compared to a placebo, on endurance exercise performance.
- Conditions
- Healthy Volunteers
- Being tested
- Ladder Supplement, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ladder SupplementDietary supplement
Caffeine 200mg L-Theanine 200mg L-Citrulline 6g Creatine 5g Beta-Alanine 1.6g Phosphatidylserine 100mg
PlaceboDietary supplement
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Ladder Supplement | Experimental | Ladder Supplement Receives: Dietary Supplement: Ladder Supplement |
| Placebo | Placebo comparator | Placebo Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Exercise Performance
Work done during 15 min time trial (TT)
Measured: 15 Minitues
Secondary outcomes (4)
Alertness
Visual analog scale
Measured: 1 Hour
Motivation
Visual analog scale
Measured: 1 Hour
Rate of perceived exertion
Visual analog scale
Measured: 1 Hour
Gas analysis
Analysis of expired gas
Measured: 1 Hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2022
- Study start2 Dec 2021
- Primary completion31 Aug 2022
- Study completion30 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies 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
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Exeter
- Sponsor type
- University, hospital or other
- Collaborators
- OpenFit LLC
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05230862
- Sponsor's protocol ID
- 2021-M-38
- Acronym
- MIPS
- Status last verified
- Jul 2025
- First submitted
- 10 Jan 2022
- Last updated
- 31 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does a Multi-ingredient Pre-workout Supplement Enhance Cycling Time Trial
- ClinicalTrials.gov ID
- NCT05230862
- Acronym / sponsor ID
- MIPS / 2021-M-38
- Conditions
- Healthy Volunteers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of ExeterUniversity, hospital or other
- Collaborators
- OpenFit LLC
- Study start
- 2 Dec 2021 (actual)
- Primary completion
- 31 Aug 2022 (actual)
- Study completion
- 30 Sep 2022 (actual)
- First posted
- 9 Feb 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 aim of the present study is to test the effect of ingesting a multi-ingredient pre- exercise supplement containing caffeine, creatine, beta-alanine and L-Citrulline compared to a placebo, on endurance exercise performance.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ladder Supplement | Experimental | Dietary Supplement: Ladder SupplementLadder Supplement |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboPlacebo |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age 18-40
- Healthy
- Highly trained endurance athletes (V̇O2max: males >55 and females >50 mL⋅kg bm-1⋅min-1)
- Both males and females are allowed to participate. If females are on the oral contraceptive pill they are to be tested on consecutive weeks. If they are not on the oral contraceptive pill, then female subjects are to be tested every 4 weeks, at the same point of their menstrual cycle.
Key exclusion criteria (8 listed)
- Any diagnosed metabolic health condition
- Pregnant
- Non-habitual caffeine intake
- Smoker
- No endurance training
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 |
|---|---|---|
| Ladder SupplementCaffeine 200mg L-Theanine 200mg L-Citrulline 6g Creatine 5g Beta-Alanine 1.6g Phosphatidylserine 100mg | Dietary supplement | Ladder Supplement |
| PlaceboPlacebo | Dietary supplement | Placebo |
Primary outcome
Exercise Performance
Time frame: 15 Minitues
Work done during 15 min time trial (TT)
4 secondary outcomes
Alertness
Time frame: 1 Hour
Motivation
Time frame: 1 Hour
Rate of perceived exertion
Time frame: 1 Hour
Gas analysis
Time frame: 1 Hour
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 31 Jul 2025.
Related trials for Healthy Volunteers
Not yet recruitingPhase 1
A Study of Phenytoin Mucoadhesive Film for Oral Ulcers in Healthy Volunteers
Oral Ulcer, Oral Mucositis
Not yet recruiting
SUVY VerSus SAccharose (SUVISA)
Healthy Volunteers, Erythritol
Not yet recruitingObservational study
Microneurographic Assessment of Peripheral Nerves in Healthy Volunteers and Individuals With Sensory Dysfunction Caused by Inherited Mutations in the PIEZO2 Gene
PIEZO2-Deficiency Syndrome
Enrolling by invitationObservational study
Connors Protocol for the Management and Use of Stored Human Specimens (Stored Human Specimens)
Healthy Volunteer Samples
RecruitingPhase 1
First-in-Human Evaluation of [11C]JMJ-129-d2 for PDE4D Imaging in Healthy Volunteers
Healthy
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 Ladder Supplement in people with Healthy Volunteers, 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 4 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 31 Jul 2025. 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?
Exercise Performance (time frame: 15 Minitues). 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 31 Jul 2025.