Exercise PerformanceNCT06489587
Creatine Supplementation At Simulated Altitude
A study testing Creatine in people with Exercise Performance, run by California Polytechnic State University-San Luis Obispo at 1 site in United States.
Trial summary
Creatine supplementation has been shown to increase exercise performance at sea level. The goal of this study is to determine the effects of creatine supplementation on exercise performance at simulated altitude. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Exercise Performance
- What is being tested?
- Creatine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Jun 2024to Jun 2026
- 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
- 18-40 years old
- BMI 18.5 to 40 kg/m2
- Habitually active (>150 minutes per week of moderate-vigorous physical activity)
Who cannot join
- Pregnant or trying to become pregnant
- Recent use of creatine supplementation
- Supplemental allergies
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
California Polytechnic State University
San Luis Obispo, California, 93407
Todd Hagobian, PhD, 805-756-7511, thagobia@calpoly.edu
Eric Benso, BS, 805-756-7525, ecbenson@calpoly.edu
About this study
Creatine supplementation has been shown to increase exercise performance at sea level. The goal of this study is to determine the effects of creatine supplementation on exercise performance at simulated altitude.
Read the detailed description
Military personnel often encounter harsh environments such as high altitudes and hypoxic conditions, leading to significant constraints on their exercise capacity and performance. At sea-level creatine supplementation increases exercise performance; however no experimental studies have examined the effect of creatine supplementation at simulated altitude. The overall objective of this study is to investigate the effects of creatine supplementation on exercise performance, via a repeated sprints test (Wingate Test) after a 2-day supplementation period, compared to a placebo group.
- Conditions
- Exercise Performance
- Being tested
- Placebo, Creatine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDietary supplement
Participants given 40 grams of glucose in total to be taken over 2 days, in 5-gram servings (4 capsules), 4 times per day.
CreatineDietary supplement
Participants given 40 grams of creatine in total to be taken over 2 days, in 5-gram servings (4 capsules), 4 times per day.
| Study group | Role | What they receive |
|---|---|---|
| Placebo Supplementation | Active comparator | Participants given Placebo (20 grams of glucose) daily in 5-gram servings (4 capsules), 4 times per day for 2 days. Receives: Dietary Supplement: Placebo |
| Creatine Supplementation | Experimental | Participants given Creatine (20 grams of glucose) daily in 5-gram servings (4 capsules), 4 times per day for 2 days. Receives: Dietary Supplement: Creatine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak power
Peak power is measured in watts.
Measured: Change from baseline to 3 days
Secondary outcomes (5)
Body Weight
Body weight is measured in kilograms.
Measured: Change from baseline to 3 days
Relative peak power
Relative peak power is measured in watts per kilogram.
Measured: Change from baseline to 3 days
Mean power
Mean power is measured in watts.
Measured: Change from baseline to 3 days
Relative mean power
Relative mean power is measured in watts per kilogram.
Measured: Change from baseline to 3 days
Fatigue index
Fatigue index is measured in watts per second.
Measured: Change from baseline to 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2024
- Study start25 Jun 2024
- Primary completionJun 2025 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Exercise 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized study to two arms: 1) creatine supplementation, 2) glucose supplementation
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- California Polytechnic State University-San Luis Obispo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Todd Hagobian, California Polytechnic State University-San Luis Obispo
- Investigators
- Todd Hagobian, PhD, Principal investigator, California Polytechnic State University-San Luis Obispo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06489587
- Sponsor's protocol ID
- 2023-233
- Status last verified
- Jul 2024
- First submitted
- 25 Jun 2024
- Last updated
- 8 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data and documentation will be available under a data-sharing agreement. Information shared with outside collaborators will link data to two unique study identifiers (de-Identified) to maintain participant anonymity, and outside researchers and the community will not be allowed to have access to participant names and confidential information.
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Creatine Supplementation At Simulated Altitude
- ClinicalTrials.gov ID
- NCT06489587
- Acronym / sponsor ID
- 2023-233
- Conditions
- Exercise Performance
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- California Polytechnic State University-San Luis ObispoUniversity, hospital or other
- Study start
- 25 Jun 2024 (actual)
- Primary completion
- Jun 2025 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 8 Jul 2024 (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.
Creatine supplementation has been shown to increase exercise performance at sea level. The goal of this study is to determine the effects of creatine supplementation on exercise performance at simulated altitude.
Detailed description
Military personnel often encounter harsh environments such as high altitudes and hypoxic conditions, leading to significant constraints on their exercise capacity and performance. At sea-level creatine supplementation increases exercise performance; however no experimental studies have examined the effect of creatine supplementation at simulated altitude. The overall objective of this study is to investigate the effects of creatine supplementation on exercise performance, via a repeated sprints test (Wingate Test) after a 2-day supplementation period, compared to a placebo group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized study to two arms: 1) creatine supplementation, 2) glucose supplementation
| Arm | Type | Receives |
|---|---|---|
| Placebo Supplementation | Active comparator | Dietary Supplement: PlaceboParticipants given Placebo (20 grams of glucose) daily in 5-gram servings (4 capsules), 4 times per day for 2 days. |
| Creatine Supplementation | Experimental | Dietary Supplement: CreatineParticipants given Creatine (20 grams of glucose) daily in 5-gram servings (4 capsules), 4 times per day for 2 days. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 18-40 years old
- BMI 18.5 to 40 kg/m2
- Habitually active (>150 minutes per week of moderate-vigorous physical activity)
Key exclusion criteria (3 listed)
- Pregnant or trying to become pregnant
- Recent use of creatine supplementation
- Supplemental allergies
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 |
|---|---|---|
| PlaceboParticipants given 40 grams of glucose in total to be taken over 2 days, in 5-gram servings (4 capsules), 4 times per day. | Dietary supplement | Placebo Supplementation |
| CreatineParticipants given 40 grams of creatine in total to be taken over 2 days, in 5-gram servings (4 capsules), 4 times per day. | Dietary supplement | Creatine Supplementation |
Primary outcome
Peak power
Time frame: Change from baseline to 3 days
Peak power is measured in watts.
5 secondary outcomes
Body Weight
Time frame: Change from baseline to 3 days
Relative peak power
Time frame: Change from baseline to 3 days
Mean power
Time frame: Change from baseline to 3 days
Relative mean power
Time frame: Change from baseline to 3 days
Fatigue index
Time frame: Change from baseline to 3 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2024.
- Individual participant dataSharing planned: Yes. Data and documentation will be available under a data-sharing agreement. Information shared with outside collaborators will link data to two unique study identifiers (de-Identified) to maintain participant anonymity, and outside researchers and the community will not be allowed to have access to participant names and confidential information.
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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.
Todd Hagobian, PhD principal investigator
California Polytechnic State University-San Luis Obispo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Creatine in people with Exercise Performance, run by California Polytechnic State University-San Luis Obispo at 1 site in United States.
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 8 Jul 2024. 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 States. 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. 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?
Contact Todd Hagobian, PhD (8057567511, thagobia@calpoly.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peak power (time frame: Change from baseline to 3 days). 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 8 Jul 2024.