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Clinical Trials/NCT05482997
NCT05482997CompletedNot Applicable

Athlete Whey Protein Sensitivity: Prevalence and Performance

University of the Incarnate Word2 sites in 1 country36 target enrollmentStarted: January 16, 2023Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
36
Locations
2
Primary Endpoint
Change from Baseline Performance Questionnaire at 4 weeks

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Primary Purpose
Supportive Care
Masking
Single (Participant)

Masking Description

single-blinded (subject only)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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)

Outcomes

Primary Outcomes

Change from Baseline Performance Questionnaire at 4 weeks

Time Frame: 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

Time Frame: 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

Time Frame: 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.

Secondary Outcomes

  • 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)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Brittanie L. Lockard

Assistant Professor

University of the Incarnate Word

Study Sites (2)

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