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临床试验/NCT06483321
NCT06483321已完成不适用

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

Universidad Francisco de Vitoria1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2024年7月30日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
20
试验地点
1
主要终点
Countermovement jump (CMJ)

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Investigator)

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 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/m
  • No tobacco use.
  • No or low alcohol consumption and no orthopedic limitations that would interfere with the performance of the study tests.

排除标准

  • 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

结局指标

主要结局

Countermovement jump (CMJ)

时间窗: 4 weeks

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

Body weight

时间窗: 4 weeks

Body weight in kg

15-repeated-jumps test

时间窗: 4 weeks

Height of each individual jump,recorded in centimeters

Lean mass

时间窗: 4 weeks

Lean mass in kg

30-meter sprint

时间窗: 4 weeks

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

次要结局

  • Maximum isometric force(4 weeks)
  • Blood creatine(4 weeks)
  • Blood creatinine(4 weeks)

研究者

发起方
Universidad Francisco de Vitoria
申办方类型
Other
责任方
Sponsor

研究点 (1)

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