Effect of Creatine Supplementation on Physical Performance in Vegan Subjects (CREATINVEG)
Effect of Creatine Supplementation on Physical Performance and Body Composition in Vegan Subjects
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Madrid
-
Madrid, Madrid, Spain, 28223
- Francisco de Vitoria University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Creatine Supplementation
Normocaloric vegan diet supplemented with 0.1 g/kg/day of creatine monohydrate
|
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) |
|
Placebo Comparator: Placebo
Normocaloric vegan diet supplemented with 0.1 g/kg/day of placebo (maltodextrin)
|
Normocaloric vegan diet supplemented with 0.1 g/kg/day of placebo (maltodextrin)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Body weight
Time Frame: 4 weeks
|
Body weight in kg
|
4 weeks
|
|
30-meter sprint
Time Frame: 4 weeks
|
Time (in seconds) taken to complete the 30-meter distance
|
4 weeks
|
|
Countermovement jump (CMJ)
Time Frame: 4 weeks
|
Force output and calculates jump height based on flight time and take-off velocity
|
4 weeks
|
|
15-repeated-jumps test
Time Frame: 4 weeks
|
Height of each individual jump,recorded in centimeters
|
4 weeks
|
|
Lean mass
Time Frame: 4 weeks
|
Lean mass in kg
|
4 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Maximum isometric force
Time Frame: 4 weeks
|
Peak force exerted during the test, typically recorded inkilograms-force (kg)
|
4 weeks
|
|
Blood creatine
Time Frame: 4 weeks
|
Milligrams of creatine per deciliter of blood (mg/dL) and in micromoles of creatine per liter of blood (micromoles/L)
|
4 weeks
|
|
Blood creatinine
Time Frame: 4 weeks
|
Milligrams of creatinine per deciliter of blood (mg/dL) and in micromoles of creatinine per liter of blood (micromoles/L)
|
4 weeks
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 12/2024
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.