Deficiency; DietCREATINVEGNCT06483321
Effect of Creatine Supplementation on Physical Performance in Vegan Subjects
A study testing Creatine Supplementation in people with Deficiency; Diet, run by Universidad Francisco de Vitoria at 1 site in Spain.
Trial summary
The primary objective of this study is to investigate the effect of creatine monohydrate supplementation on body composition, physical performance, and muscle creatine levels in vegan individuals over four weeks. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Deficiency; Diet
- What is being tested?
- Creatine Supplementation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteSpain
- Study dates
- 30 Jul 2024to 30 Sep 2024
- 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
- Vegan diet for at least 6 months prior to the study's start.
- Aged between 18-40 years.
- Physically active according to the recommendations of the World Health Organization (WHO).
- Body Mass Index (BMI) between 18.5-24.9 kg/m2.
- No tobacco use.
- No or low alcohol consumption and no orthopedic limitations that would interfere with the performance of the study tests.
Who cannot join
- Chronic diseases that impair athletic performance (cardiovascular, metabolic, gastrointestinal, respiratory) within the last six months.
- Musculoskeletal disease within the last six months.
- Creatine supplementation prior to the study's start
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Creatine Supplementation on Physical Performance and Body Composition in Vegan Subjects
The primary objective of this study is to investigate the effect of creatine monohydrate supplementation on body composition, physical performance, and muscle creatine levels in vegan individuals over four weeks.
Read the detailed description
This randomized, double-blind, placebo-controlled clinical study aims to evaluate the effect of creatine monohydrate supplementation on body composition, physical performance, and plasma biomarkers in 20 vegan individuals (10 men and 10 women) over a 4-week period. Participants, who will have followed a strict vegan diet for at least 6 months prior to the study's start, will be randomly assigned to one of two groups: one receiving 0.1 grams of creatine monohydrate daily and the other receiving a placebo (maltodextrin). A dietitian-nutritionist will standardize the participants' diet to ensure it is normocaloric and equivalent in macronutrient distribution. To ensure proper dietary control, 3-day dietary records (two weekdays and one weekend day) will be maintained both at the start of the study and during the last week of the intervention.
Assessments will be conducted before the start of the study (week 0) and at the end (week 4), and will include body composition measurements using the InBody system, physical tests (30-meter sprint, dynamometry, countermovement jump (CMJ), maximum isometric force, and a 15-repeated-jumps test), as well as blood analyses for creatine, creatinine, and creatine kinase (CK) levels, and urine analyses for creatine excretion. It is expected that creatine supplementation in vegan subjects will significantly increase lean muscle mass, improve physical performance in the mentioned tests, and elevate muscle creatine levels while decreasing markers of muscle damage (CK). Statistical analysis will include a repeated measures ANOVA to evaluate changes in dependent variables between groups over time, with a significance level set at p < 0.05.
- Conditions
- Deficiency; Diet
- Being tested
- Creatine Supplementation, Placebo
- Keywords
- Performance, Vegan diet, Creatine, Strenght
- Medical subject headings
- Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Creatine SupplementationDietary supplement
Normocaloric vegan diet supplemented with 0.1 g/kg/day of creatine monohydrate
Normocaloric diet based solely on foods of plant sources with creatine supplementatio (0.1 g/kg/day)
PlaceboDietary supplement
Normocaloric vegan diet supplemented with 0.1 g/kg/day of placebo (maltodextrin)
| Study group | Role | What they receive |
|---|---|---|
| Creatine Supplementation | Experimental | Normocaloric vegan diet supplemented with 0.1 g/kg/day of creatine monohydrate Receives: Dietary Supplement: Creatine Supplementation |
| Placebo | Placebo comparator | Normocaloric vegan diet supplemented with 0.1 g/kg/day of placebo (maltodextrin) Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
30-meter sprint
Time (in seconds) taken to complete the 30-meter distance
Measured: 4 weeks
Countermovement jump (CMJ)
Force output and calculates jump height based on flight time and take-off velocity
Measured: 4 weeks
15-repeated-jumps test
Height of each individual jump,recorded in centimeters
Measured: 4 weeks
Body weight
Body weight in kg
Measured: 4 weeks
Lean mass
Lean mass in kg
Measured: 4 weeks
Secondary outcomes (3)
Maximum isometric force
Peak force exerted during the test, typically recorded inkilograms-force (kg)
Measured: 4 weeks
Blood creatine
Milligrams of creatine per deciliter of blood (mg/dL) and in micromoles of creatine per liter of blood (micromoles/L)
Measured: 4 weeks
Blood creatinine
Milligrams of creatinine per deciliter of blood (mg/dL) and in micromoles of creatinine per liter of blood (micromoles/L)
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2024
- Study start30 Jul 2024
- Primary completion30 Aug 2024
- Study completion30 Sep 2024
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 Deficiency; DietStudies 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
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Francisco de Vitoria
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06483321
- Sponsor's protocol ID
- 12/2024
- Acronym
- CREATINVEG
- Status last verified
- Jul 2024
- First submitted
- 27 Jun 2024
- Last updated
- 24 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lopez-Moreno M, Munoz A, Aguilar-Navarro M, Gutierrez-Hellin J, Franco-Andres A, Lopez-Lopez P, Crespo-Canizares A, Marrero-Fernandez P, Forbes SC. Does creatine supplementation improve strength and power in physically active individuals on a vegan diet? a randomized, triple-blind, placebo-controlled trial. Eur J Appl Physiol. 2026 Jul 2. doi: 10.1007/s00421-026-06323-5. Online ahead of print.
PubMed 42390589
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Creatine Supplementation on Physical Performance and Body Composition in Vegan Subjects
- ClinicalTrials.gov ID
- NCT06483321
- Acronym / sponsor ID
- CREATINVEG / 12/2024
- Conditions
- Deficiency; Diet
- Keywords
- Performance, Vegan diet, Creatine, Strenght
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Universidad Francisco de VitoriaUniversity, hospital or other
- Study start
- 30 Jul 2024 (actual)
- Primary completion
- 30 Aug 2024 (actual)
- Study completion
- 30 Sep 2024 (actual)
- First posted
- 3 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.
The primary objective of this study is to investigate the effect of creatine monohydrate supplementation on body composition, physical performance, and muscle creatine levels in vegan individuals over four weeks.
Detailed description
This randomized, double-blind, placebo-controlled clinical study aims to evaluate the effect of creatine monohydrate supplementation on body composition, physical performance, and plasma biomarkers in 20 vegan individuals (10 men and 10 women) over a 4-week period. Participants, who will have followed a strict vegan diet for at least 6 months prior to the study's start, will be randomly assigned to one of two groups: one receiving 0.1 grams of creatine monohydrate daily and the other receiving a placebo (maltodextrin). A dietitian-nutritionist will standardize the participants' diet to ensure it is normocaloric and equivalent in macronutrient distribution. To ensure proper dietary control, 3-day dietary records (two weekdays and one weekend day) will be maintained both at the start of the study and during the last week of the intervention.
Assessments will be conducted before the start of the study (week 0) and at the end (week 4), and will include body composition measurements using the InBody system, physical tests (30-meter sprint, dynamometry, countermovement jump (CMJ), maximum isometric force, and a 15-repeated-jumps test), as well as blood analyses for creatine, creatinine, and creatine kinase (CK) levels, and urine analyses for creatine excretion. It is expected that creatine supplementation in vegan subjects will significantly increase lean muscle mass, improve physical performance in the mentioned tests, and elevate muscle creatine levels while decreasing markers of muscle damage (CK). Statistical analysis will include a repeated measures ANOVA to evaluate changes in dependent variables between groups over time, with a significance level set at p < 0.05.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Creatine Supplementation | Experimental | Dietary Supplement: Creatine SupplementationNormocaloric vegan diet supplemented with 0.1 g/kg/day of creatine monohydrate |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboNormocaloric vegan diet supplemented with 0.1 g/kg/day of placebo (maltodextrin) |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Vegan diet for at least 6 months prior to the study's start.
- Aged between 18-40 years.
- Physically active according to the recommendations of the World Health Organization (WHO).
- Body Mass Index (BMI) between 18.5-24.9 kg/m2.
- No tobacco use.
Key exclusion criteria (3 listed)
- Chronic diseases that impair athletic performance (cardiovascular, metabolic, gastrointestinal, respiratory) within the last six months.
- Musculoskeletal disease within the last six months.
- Creatine supplementation prior to the study's start
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 |
|---|---|---|
| Creatine SupplementationNormocaloric vegan diet supplemented with 0.1 g/kg/day of creatine monohydrate Normocaloric diet based solely on foods of plant sources with creatine supplementatio (0.1 g/kg/day) | Dietary supplement | Creatine Supplementation |
| PlaceboNormocaloric vegan diet supplemented with 0.1 g/kg/day of placebo (maltodextrin) | Dietary supplement | Placebo |
Primary outcome
30-meter sprint
Time frame: 4 weeks
Time (in seconds) taken to complete the 30-meter distance
Countermovement jump (CMJ)
Time frame: 4 weeks
Force output and calculates jump height based on flight time and take-off velocity
15-repeated-jumps test
Time frame: 4 weeks
Height of each individual jump,recorded in centimeters
Body weight
Time frame: 4 weeks
Body weight in kg
Lean mass
Time frame: 4 weeks
Lean mass in kg
3 secondary outcomes
Maximum isometric force
Time frame: 4 weeks
Blood creatine
Time frame: 4 weeks
Blood creatinine
Time frame: 4 weeks
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 24 Mar 2026.
- Derived from this study: PubMed 42390589Lopez-Moreno M, Munoz A, Aguilar-Navarro M, Gutierrez-Hellin J, Franco-Andres A, Lopez-Lopez P, Crespo-Canizares A, Marrero-Fernandez P, Forbes SC. Does creatine supplementation improve strength and power in physically active individuals on a vegan diet? a randomized, triple-blind, placebo-controlled trial. Eur J Appl Physiol. 2026 Jul 2. doi: 10.1007/s00421-026-06323-5. Online ahead of print.
- Individual participant dataSharing planned: No
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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 Creatine Supplementation in people with Deficiency; Diet, run by Universidad Francisco de Vitoria at 1 site in Spain.
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 6 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 24 Mar 2026. 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 Spain. 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?
30-meter sprint (time frame: 4 weeks). The study lists 5 primary outcomes in all. 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 NCT06483321, 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 24 Mar 2026.