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临床试验/NCT05482997
NCT05482997已完成不适用

Athlete Whey Protein Sensitivity: Prevalence and Performance

University of the Incarnate Word2 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2023年1月16日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
36
试验地点
2
主要终点
Change from Baseline Performance Questionnaire at 4 weeks

研究概览

简要总结

The objective of this study is to identify the prevalence of whey protein sensitivity in UIW athletes and to assess the effectiveness of 4-weeks of whey versus plant-based protein supplementation on athletic performance and recovery, specifically in those with whey sensitivity.

详细描述

Dependent t-tests and repeated measures analysis of variance (ANOVA) will offer comparative analyses between whey and plant protein conditions in subjects with and without whey sensitivity. Symptom questionnaires, perceived performance questionnaires, wearable fitness tracking data, and strength test results will be compared across all four conditions (baseline, washout, whey supplementation, and plant supplementation).

Related variables will be analyzed using GLM univariate, multivariate, and repeated measures. The overall multivariate Wilks' Lambda and Greenhouse-Geisser univariate p-levels will be reported. Differences among groups will be determined using Tukey's least significant differences (LSD) post hoc analyses.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Supportive Care
盲法
Single (Participant)

盲法说明

single-blinded (subject only)

入排标准

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

入选标准

  • NCAA Division I collegiate athletes at the University of the Incarnate Word
  • Must complete a medical history form
  • Must be cleared by sports medicine staff for intercollegiate athletic participation

排除标准

  • Individuals with a diagnosed food allergy, lactose intolerance, or inflammatory bowel disease (such as Chron's, Ulcerative Colitis, or Celiac Sprue)

结局指标

主要结局

Change from Baseline Performance Questionnaire at 4 weeks

时间窗: Baseline, 4 weeks, 6 weeks, 10 weeks

subject assesses food sensitivity symptoms, perceived recovery after athletic event, and satisfaction with athletic performance.

Change from Baseline Vertical Jump Test at 4 weeks

时间窗: Baseline, 4 weeks, 6 weeks, 10 weeks

The vertical jump measures explosive leg power and is an effective indirect measurement of athletic performance. The participant will utilize the Just Jump Mat to electronically assess vertical height.

Change from Baseline InBody Body Composition Test at 4 weeks

时间窗: Baseline, 4 weeks, 6 weeks, 10 weeks

Body composition assessed by subjects standing on bioelectrical impedance analysis scale that measures total body water, lean body mass, dy lean mass, body fat mass, and weight.

次要结局

  • Number of Participants with Declining Measures(Baseline, 4 weeks, 6 weeks, 10 weeks)
  • Number of Athletes with Whey Sensitivity(Baseline)
  • Number of Participants with Increasing Measures(Baseline, 4 weeks, 6 weeks, 10 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Brittanie L. Lockard

Assistant Professor

University of the Incarnate Word

研究点 (2)

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