An interventional study of Creatine Supplementation and Placebo in Deficiency; Diet, sponsored by Universidad Francisco de Vitoria. Completed at 1 site in Spain. Open to participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-03-24.
Sponsored by Universidad Francisco de Vitoria · Not applicable, Interventional, and Treatment
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.
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.
1,587 studies on the registry are indexed under Malnutrition; 237 are open to participants now.
This study's enrollment of 20 is below the median of 90 across 1,134 interventional studies indexed under Malnutrition.
Browse Malnutrition studies →Universidad Francisco de Vitoria is the lead sponsor of 52 studies on the registry; 15 are open to participants now.
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Exclusion Criteria:
Normocaloric vegan diet supplemented with 0.1 g/kg/day of creatine monohydrate
Dietary Supplement: Creatine Supplementation
Normocaloric vegan diet supplemented with 0.1 g/kg/day of placebo (maltodextrin)
Dietary Supplement: Placebo
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)
Normocaloric vegan diet supplemented with 0.1 g/kg/day of placebo (maltodextrin)
30-meter sprint
Time (in seconds) taken to complete the 30-meter distance
Time frame: 4 weeks
Countermovement jump (CMJ)
Force output and calculates jump height based on flight time and take-off velocity
Time frame: 4 weeks
15-repeated-jumps test
Height of each individual jump,recorded in centimeters
Time frame: 4 weeks
Body weight
Body weight in kg
Time frame: 4 weeks
Lean mass
Lean mass in kg
Time frame: 4 weeks
Maximum isometric force
Peak force exerted during the test, typically recorded inkilograms-force (kg)
Time frame: 4 weeks
Blood creatine
Milligrams of creatine per deciliter of blood (mg/dL) and in micromoles of creatine per liter of blood (micromoles/L)
Time frame: 4 weeks
Blood creatinine
Milligrams of creatinine per deciliter of blood (mg/dL) and in micromoles of creatinine per liter of blood (micromoles/L)
Time frame: 4 weeks
Plan to share: No
This study is completed, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.
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Universidad Francisco de Vitoria