Ignite Creation Date:
2024-07-17 @ 11:01 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06483321
Status:
RECRUITING
Last Update Posted:
2024-07-03
First Post:
2024-06-27
Brief Title:
Effect of Creatine Supplementation on Physical Performance in Vegan Subjects
Sponsor:
Universidad Francisco de Vitoria
Organization:
Universidad Francisco de Vitoria
Study Overview
Official Title:
Effect of Creatine Supplementation on Physical Performance and Body Composition in Vegan Subjects
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CREATINVEG
Brief 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
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 studys start will be randomly assigned to one of two groups one receiving 001 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 005
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 005
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None