Athlete Whey Protein Sensitivity: Prevalence and Performance

July 22, 2023 updated by: Brittanie L. Lockard, University of the Incarnate Word
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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • San Antonio, Texas, United States, 78209
        • The University of the Incarnate Word

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control Group: Subjects with no protien intake
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

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
whey-based protein powder 32g powder mixed with 8-12 oz water
Other Names:
  • True Nutrition Whey Protein Concentrate
Dietary supplement: Pea Protein Isolate, Rice Protein Concentrate, Hemp Protein
plant-based protein powder. 32g powder mixed with 8-12 oz water
Other Names:
  • True Nutrition Vegan Protein Optimizer Formula
Experimental: Plant-based Protein, Then Whey Protein

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
whey-based protein powder 32g powder mixed with 8-12 oz water
Other Names:
  • True Nutrition Whey Protein Concentrate
Dietary supplement: Pea Protein Isolate, Rice Protein Concentrate, Hemp Protein
plant-based protein powder. 32g powder mixed with 8-12 oz water
Other Names:
  • True Nutrition Vegan Protein Optimizer Formula

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline, 4 weeks, 6 weeks, 10 weeks
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.
Baseline, 4 weeks, 6 weeks, 10 weeks
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.
Baseline, 4 weeks, 6 weeks, 10 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline, 4 weeks, 6 weeks, 10 weeks
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.
Baseline, 4 weeks, 6 weeks, 10 weeks
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.
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of the Incarnate Word

Investigators

  • Principal Investigator: Brittanie L Lockard, PhD, University of the Incarnate Word

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 16, 2023

Primary Completion (Estimated)

December 31, 2023

Study Completion (Estimated)

December 31, 2023

Study Registration Dates

First Submitted

July 28, 2022

First Submitted That Met QC Criteria

July 28, 2022

First Posted (Actual)

August 1, 2022

Study Record Updates

Last Update Posted (Actual)

July 25, 2023

Last Update Submitted That Met QC Criteria

July 22, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022-1154-EXP

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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