Clinical trial NCT06483321: Effect of Creatine Supplementation on Physical Performance in Vegan Subjects
Official title: Effect of Creatine Supplementation on Physical Performance and Body Composition in Vegan Subjects
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Deficiency; Diet
Keywords: Performance
Vegan diet
Creatine
Strenght
Lead sponsor: Universidad Francisco de Vitoria
Sponsor class: OTHER
First posted: 2024-07-03
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 study's start, will be randomly assigned to one of two groups: one receiving 0.01 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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

Primary outcomes:
measure: 30-meter sprint
timeFrame: 4 weeks
measure: Countermovement jump (CMJ)
timeFrame: 4 weeks
measure: 15-repeated-jumps test
timeFrame: 4 weeks
measure: Body weight
timeFrame: 4 weeks
measure: Lean mass
timeFrame: 4 weeks
Secondary outcomes:
measure: Maximum isometric force
timeFrame: 4 weeks
measure: Blood creatine
timeFrame: 4 weeks
measure: Blood creatinine
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Francisco de Vitoria University
Study officials:
References: