Effect of Creatine Supplementation on Physical Performance in Vegan Subjects

NCT ID: NCT06483321

Last Updated: 2024-07-17

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-30
• Study Completion Date: 2024-09-30

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.

Conditions

Deficiency; Diet

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Creatine Supplementation

Normocaloric vegan diet supplemented with 0.1 g/kg/day of creatine monohydrate

Group Type: EXPERIMENTAL

Creatine Supplementation

Intervention Type: 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

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

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

Interventions

Creatine Supplementation

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)

Intervention Type: DIETARY_SUPPLEMENT

Placebo

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

Intervention Type: DIETARY_SUPPLEMENT

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Universidad Francisco de Vitoria

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Francisco de Vitoria University

Madrid, , Spain

Site Status: RECRUITING

Countries

Spain

Facility Contacts

Miguel López Moreno, PhD

Role: primary

miguel.lopez@ufv.es

647892334 ext. 32

Other Identifiers

12/2024

Identifier Type: -

Identifier Source: org_study_id