Clinical trial NCT05482997: Athlete Whey Protein Sensitivity: Prevalence and Performance
Official title: Athlete Whey Protein Sensitivity: Prevalence and Performance
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Food Intolerance
Lead sponsor: University of the Incarnate Word
Sponsor class: OTHER
First posted: 2022-08-01
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

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

Primary outcomes:
measure: Change from Baseline Performance Questionnaire at 4 weeks
timeFrame: Baseline, 4 weeks, 6 weeks, 10 weeks
measure: Change from Baseline InBody Body Composition Test at 4 weeks
timeFrame: Baseline, 4 weeks, 6 weeks, 10 weeks
measure: Change from Baseline Vertical Jump Test at 4 weeks
timeFrame: Baseline, 4 weeks, 6 weeks, 10 weeks
Secondary outcomes:
measure: Number of Participants with Declining Measures
timeFrame: Baseline, 4 weeks, 6 weeks, 10 weeks
measure: Number of Participants with Increasing Measures
timeFrame: Baseline, 4 weeks, 6 weeks, 10 weeks
measure: Number of Athletes with Whey Sensitivity
timeFrame: Baseline
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: The University of the Incarnate Word
state: Texas
Study officials:
affiliation: University of the Incarnate Word
name: Brittanie L Lockard, PhD
role: PRINCIPAL_INVESTIGATOR
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