Back to resultsAthlete Whey Protein Sensitivity: Prevalence and Performance
Primary Purpose
Food Intolerance
Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Whey Protein Concentrate
Pea Protein Isolate, Rice Protein Concentrate, Hemp Protein
Sponsored by
About this trial
This is an interventional supportive care trial for Food Intolerance
Eligibility Criteria
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)
Sites / Locations
- The University of the Incarnate Word
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
No Intervention
Experimental
Experimental
Arm Label
Control Group: Subjects with no protien intake
Whey Protein, Then Plant-based Protein
Plant-based Protein, Then Whey Protein
Arm Description
20 subjects will receive no intervention for 10 weeks but complete performance tests and assessments during weeks 0, 4, 6, and 10.
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.
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.
Outcomes
Primary Outcome Measures
Change from Baseline Performance Questionnaire at 4 weeks
subject assesses food sensitivity symptoms, perceived recovery after athletic event, and satisfaction with athletic performance.
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.
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.
Secondary Outcome Measures
Number of Participants with Declining Measures
The number of subjects whose self assessment, body composition, and vertical jump depreciate.
Number of Participants with Increasing Measures
The number of subjects whose self assessment, body composition, and vertical jump improve.
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.
Full Information
NCT ID
NCT05482997
First Posted
July 28, 2022
Last Updated
July 22, 2023
Sponsor
University of the Incarnate Word
1. Study Identification
Unique Protocol Identification Number
NCT05482997
Brief Title
Athlete Whey Protein Sensitivity: Prevalence and Performance
Official Title
Athlete Whey Protein Sensitivity: Prevalence and Performance
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
January 16, 2023 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of the Incarnate Word
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Food Intolerance
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Masking Description
single-blinded (subject only)
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control Group: Subjects with no protien intake
Arm Type
No Intervention
Arm Description
20 subjects will receive no intervention for 10 weeks but complete performance tests and assessments during weeks 0, 4, 6, and 10.
Arm Title
Whey Protein, Then Plant-based Protein
Arm Type
Experimental
Arm Description
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.
Arm Title
Plant-based Protein, Then Whey Protein
Arm Type
Experimental
Arm Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Whey Protein Concentrate
Other Intervention Name(s)
True Nutrition Whey Protein Concentrate
Intervention Description
whey-based protein powder 32g powder mixed with 8-12 oz water
Intervention Type
Dietary Supplement
Intervention Name(s)
Pea Protein Isolate, Rice Protein Concentrate, Hemp Protein
Other Intervention Name(s)
True Nutrition Vegan Protein Optimizer Formula
Intervention Description
plant-based protein powder. 32g powder mixed with 8-12 oz water
Primary Outcome Measure Information:
Title
Change from Baseline Performance Questionnaire at 4 weeks
Description
subject assesses food sensitivity symptoms, perceived recovery after athletic event, and satisfaction with athletic performance.
Time Frame
Baseline, 4 weeks, 6 weeks, 10 weeks
Title
Change from Baseline InBody Body Composition Test at 4 weeks
Description
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.
Time Frame
Baseline, 4 weeks, 6 weeks, 10 weeks
Title
Change from Baseline Vertical Jump Test at 4 weeks
Description
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.
Time Frame
Baseline, 4 weeks, 6 weeks, 10 weeks
Secondary Outcome Measure Information:
Title
Number of Participants with Declining Measures
Description
The number of subjects whose self assessment, body composition, and vertical jump depreciate.
Time Frame
Baseline, 4 weeks, 6 weeks, 10 weeks
Title
Number of Participants with Increasing Measures
Description
The number of subjects whose self assessment, body composition, and vertical jump improve.
Time Frame
Baseline, 4 weeks, 6 weeks, 10 weeks
Title
Number of Athletes with Whey Sensitivity
Description
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.
Time Frame
Baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brittanie L Lockard, PhD
Organizational Affiliation
University of the Incarnate Word
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of the Incarnate Word
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78209
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Athlete Whey Protein Sensitivity: Prevalence and Performance
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