Athlete Whey Protein Sensitivity: Prevalence and Performance

Study Overview
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Brief Summary
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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
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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.

Official Title
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Athlete Whey Protein Sensitivity: Prevalence and Performance

Conditions
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Food Intolerance

Intervention / Treatment
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* Dietary Supplement: Whey Protein Concentrate
* Dietary Supplement: Pea Protein Isolate, Rice Protein Concentrate, Hemp Protein


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control Group: Subjects with no protien intake<br>20 subjects will receive no intervention for 10 weeks but complete performance tests and assessments during weeks 0, 4, 6, and 10. | |
| Experimental: Whey Protein, Then Plant-based Protein<br>Performance tests/assessments will be conducted as baseline testing without whey protein, followed by four weeks of whey protein intervention consisting of one 70cc (32g) scoop of supplement provided within an hour after athletic practice, five days a week. For athletes with more than one practice a day, the supplement will be provided after the strength training session. The powder will be shaken with 8-12oz water. Performance measured at the end of 4 weeks. After a two-week washout period, they will undergo another performance evaluation and begin the same protein supplement regimen, but with a 70cc (32g) scoop of the plant-based protein supplement. | Dietary Supplement: Whey Protein Concentrate<br>* whey-based protein powder 32g powder mixed with 8-12 oz water<br>* Other names: True Nutrition Whey Protein Concentrate;Dietary Supplement: Pea Protein Isolate, Rice Protein Concentrate, Hemp Protein<br>* plant-based protein powder. 32g powder mixed with 8-12 oz water<br>* Other names: True Nutrition Vegan Protein Optimizer Formula;|
| Experimental: Plant-based Protein, Then Whey Protein<br>Performance tests/assessments will be conducted as baseline testing without plant-based protein, followed by four weeks of plant-based protein intervention consisting of one 70cc (32g) scoop of supplement provided within an hour after athletic practice, five days a week, for four weeks. For athletes with more than one practice a day, the supplement will be provided after the strength training session. The powder will be shaken with 8-12oz water. Performance measured at the end of 4 weeks. After a two-week washout period, they will undergo another performance evaluation and begin the same protein supplement regimen, but with a 70cc (32g) scoop of the whey protein supplement. | Dietary Supplement: Whey Protein Concentrate<br>* whey-based protein powder 32g powder mixed with 8-12 oz water<br>* Other names: True Nutrition Whey Protein Concentrate;Dietary Supplement: Pea Protein Isolate, Rice Protein Concentrate, Hemp Protein<br>* plant-based protein powder. 32g powder mixed with 8-12 oz water<br>* Other names: True Nutrition Vegan Protein Optimizer Formula;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline Performance Questionnaire at 4 weeks | subject assesses food sensitivity symptoms, perceived recovery after athletic event, and satisfaction with athletic performance. | Baseline, 4 weeks, 6 weeks, 10 weeks | 
| Change from Baseline InBody Body Composition Test at 4 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. | Baseline, 4 weeks, 6 weeks, 10 weeks | 
| Change from Baseline Vertical Jump Test at 4 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. | Baseline, 4 weeks, 6 weeks, 10 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants with Declining Measures | The number of subjects whose self assessment, body composition, and vertical jump depreciate. | Baseline, 4 weeks, 6 weeks, 10 weeks | 
| Number of Participants with Increasing Measures | The number of subjects whose self assessment, body composition, and vertical jump improve. | Baseline, 4 weeks, 6 weeks, 10 weeks | 
| Number of Athletes with Whey Sensitivity | Whey sensitivity assessed with IgG food sensitivity test, where small blood sample is collected from subject and IgG antibody level measured when introduced to whey. | Baseline |