Effect of Creatine Supplementation on Physical Performance in Vegan Subjects

Last updated: July 16, 2024
Sponsor: Universidad Francisco de Vitoria
Overall Status: Active - Recruiting

Phase

N/A

Condition

Weight Loss

Diet And Nutrition

Treatment

Creatine Supplementation

Placebo

Clinical Study ID

NCT06483321
12/2024
  • Ages 18-40
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

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 interferewith the performance of the study tests.

Exclusion

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 Design

Total Participants: 20
Treatment Group(s): 2
Primary Treatment: Creatine Supplementation
Phase:
Study Start date:
July 30, 2024
Estimated Completion Date:
September 30, 2024

Study 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.

Connect with a study center

  • Francisco de Vitoria University

    Madrid, 28223
    Spain

    Active - Recruiting

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