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Athlete Whey Protein Sensitivity: Prevalence and Performance

Athlete Whey Protein Sensitivity: Prevalence and Performance

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05482997
Enrollment
36
Registered
2022-08-01
Start date
2023-01-16
Completion date
2023-12-31
Last updated
2024-06-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Food Intolerance

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.

Interventions

DIETARY_SUPPLEMENTWhey Protein Concentrate

whey-based protein powder 32g powder mixed with 8-12 oz water

DIETARY_SUPPLEMENTPea Protein Isolate, Rice Protein Concentrate, Hemp Protein

plant-based protein powder. 32g powder mixed with 8-12 oz water

Sponsors

University of the Incarnate Word
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)

Masking description

single-blinded (subject only)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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)

Design outcomes

Primary

MeasureTime frameDescription
Change from Baseline Performance Questionnaire at 4 weeksBaseline, 4 weeks, 6 weeks, 10 weekssubject assesses food sensitivity symptoms, perceived recovery after athletic event, and satisfaction with athletic performance.
Change from Baseline InBody Body Composition Test at 4 weeksBaseline, 4 weeks, 6 weeks, 10 weeksBody 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.
Change from Baseline Vertical Jump Test at 4 weeksBaseline, 4 weeks, 6 weeks, 10 weeksThe 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.

Secondary

MeasureTime frameDescription
Number of Participants with Declining MeasuresBaseline, 4 weeks, 6 weeks, 10 weeksThe number of subjects whose self assessment, body composition, and vertical jump depreciate.
Number of Participants with Increasing MeasuresBaseline, 4 weeks, 6 weeks, 10 weeksThe number of subjects whose self assessment, body composition, and vertical jump improve.
Number of Athletes with Whey SensitivityBaselineWhey sensitivity assessed with IgG food sensitivity test, where small blood sample is collected from subject and IgG antibody level measured when introduced to whey.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026