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Completed

NCT Number: NCT06483321

Effect of Creatine Supplementation on Physical Performance in Vegan Subjects

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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Key information

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Francisco de Vitoria University

Madrid, 28223, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

creatine supplementation

Dietary Supplement

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

Dietary Supplement

Normocaloric vegan diet supplemented with 0.1 g/kg/day of placebo (maltodextrin)

Primary outcomes

  1. 30-meter sprint

    Time frame: 4 weeks

    Time (in seconds) taken to complete the 30-meter distance

  2. Countermovement jump (CMJ)

    Time frame: 4 weeks

    Force output and calculates jump height based on flight time and take-off velocity

  3. 15-repeated-jumps test

    Time frame: 4 weeks

    Height of each individual jump,recorded in centimeters

  4. Body weight

    Time frame: 4 weeks

    Body weight in kg

  5. Lean mass

    Time frame: 4 weeks

    Lean mass in kg

Secondary outcomes

  1. Maximum isometric force

    Time frame: 4 weeks

    Peak force exerted during the test, typically recorded inkilograms-force (kg)

  2. 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)

  3. 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)

Sponsors and collaborators

Lead sponsor

Universidad Francisco de Vitoria

Other

Registry information

Official study title

Effect of Creatine Supplementation on Physical Performance and Body Composition in Vegan Subjects

Acronym: CREATINVEG

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jul 3, 2024
Registry last updated
Mar 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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