Athlete Whey Protein Sensitivity: Prevalence and Performance

Food Intolerance Clinical Trial

Official title:

Athlete Whey Protein Sensitivity: Prevalence and Performance

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05482997
• Other study ID #: 2022-1154-EXP
• Status: Enrolling by invitation
• Phase: N/A
• Start date: January 16, 2023
• Est. completion date: December 31, 2023

Study information

• Verified date: July 2023
• Source: University of the Incarnate Word
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 60
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Food Intolerance

Intervention

Dietary Supplement:
• Whey Protein Concentrate
whey-based protein powder 32g powder mixed with 8-12 oz water
• Pea Protein Isolate, Rice Protein Concentrate, Hemp Protein
plant-based protein powder. 32g powder mixed with 8-12 oz water

Locations

Country	Name	City	State
United States	The University of the Incarnate Word	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
University of the Incarnate Word

Country where clinical trial is conducted

United States, 

References & Publications (28)

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* Note: There are 28 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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