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OpenTrials
Completed

NCT Number: NCT05482997

Athlete Whey Protein Sensitivity: Prevalence and Performance

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.

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Key information

Conditions

Food Intolerance Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The University of the Incarnate Word

San Antonio, Texas, 78209, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Whey Protein Concentrate

Dietary Supplement

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

Other names: True Nutrition Whey Protein Concentrate

Pea Protein Isolate, Rice Protein Concentrate, Hemp Protein

Dietary Supplement

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

Other names: True Nutrition Vegan Protein Optimizer Formula

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Secondary outcomes

  1. Number of Participants with Declining Measures

    Time frame: Baseline, 4 weeks, 6 weeks, 10 weeks

    The number of subjects whose self assessment, body composition, and vertical jump depreciate.

  2. Number of Participants with Increasing Measures

    Time frame: Baseline, 4 weeks, 6 weeks, 10 weeks

    The number of subjects whose self assessment, body composition, and vertical jump improve.

  3. Number of Athletes with Whey Sensitivity

    Time frame: Baseline

    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.

Sponsors and collaborators

Lead sponsor

University of the Incarnate Word

Other

Registry information

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Aug 1, 2022
Registry last updated
Jun 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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