Francisco de Vitoria University
Madrid, 28223, Spain
NCT Number: NCT06483321
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.
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Notify Me18 year–40 year
All sexes
Interventional
Not applicable
Madrid, 28223, Spain
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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)
Time frame: 4 weeks
Time (in seconds) taken to complete the 30-meter distance
Time frame: 4 weeks
Force output and calculates jump height based on flight time and take-off velocity
Time frame: 4 weeks
Height of each individual jump,recorded in centimeters
Time frame: 4 weeks
Body weight in kg
Time frame: 4 weeks
Lean mass in kg
Time frame: 4 weeks
Peak force exerted during the test, typically recorded inkilograms-force (kg)
Time frame: 4 weeks
Milligrams of creatine per deciliter of blood (mg/dL) and in micromoles of creatine per liter of blood (micromoles/L)
Time frame: 4 weeks
Milligrams of creatinine per deciliter of blood (mg/dL) and in micromoles of creatinine per liter of blood (micromoles/L)
Universidad Francisco de Vitoria
Other
Effect of Creatine Supplementation on Physical Performance and Body Composition in Vegan Subjects
Acronym: CREATINVEG
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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