NCT06483321

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 27, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 3, 2024

Completed
27 days until next milestone

Study Start

First participant enrolled

July 30, 2024

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2024

Completed
Last Updated

March 24, 2026

Status Verified

July 1, 2024

Enrollment Period

1 month

First QC Date

June 27, 2024

Last Update Submit

March 19, 2026

Conditions

Deficiency; Diet

Keywords

PerformanceVegan dietCreatineStrenght

Outcome Measures

Primary Outcomes (5)

  • 30-meter sprint

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

    4 weeks

  • Countermovement jump (CMJ)

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

    4 weeks

  • 15-repeated-jumps test

    Height of each individual jump,recorded in centimeters

    4 weeks

  • Body weight

    Body weight in kg

    4 weeks

  • Lean mass

    Lean mass in kg

    4 weeks

Secondary Outcomes (3)

  • Maximum isometric force

    4 weeks

  • Blood creatine

    4 weeks

  • Blood creatinine

    4 weeks

Study Arms (2)

Creatine Supplementation

EXPERIMENTAL

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

Dietary Supplement: Creatine Supplementation

Placebo

PLACEBO COMPARATOR

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

Dietary Supplement: Placebo

Interventions

Creatine SupplementationDIETARY_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)

Creatine Supplementation
PlaceboDIETARY_SUPPLEMENT

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

Placebo

Eligibility Criteria

Age18 Years - 40 Years
Sexall(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Francisco de Vitoria University

Madrid, Madrid, 28223, Spain

Location

MeSH Terms

Conditions

Malnutrition

Interventions

Creatine

Condition Hierarchy (Ancestors)

Nutrition DisordersNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

GuanidinesAmidinesOrganic ChemicalsAmino AcidsAmino Acids, Peptides, and Proteins

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 27, 2024

First Posted

July 3, 2024

Study Start

July 30, 2024

Primary Completion

August 30, 2024

Study Completion

September 30, 2024

Last Updated

March 24, 2026

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)