Athlete Whey Protein Sensitivity: Prevalence and Performance

NCT ID: NCT05482997

Last Updated: 2024-06-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-16

Study Completion Date

2023-12-31

Brief Summary

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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

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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.

Conditions

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Food Intolerance

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants
single-blinded (subject only)

Study Groups

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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.

Group Type NO_INTERVENTION

No interventions assigned to this group

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.

Group Type EXPERIMENTAL

Whey Protein Concentrate

Intervention Type DIETARY_SUPPLEMENT

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

Pea Protein Isolate, Rice Protein Concentrate, Hemp Protein

Intervention Type DIETARY_SUPPLEMENT

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

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.

Group Type EXPERIMENTAL

Whey Protein Concentrate

Intervention Type DIETARY_SUPPLEMENT

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

Pea Protein Isolate, Rice Protein Concentrate, Hemp Protein

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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Whey Protein Concentrate

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

Intervention Type DIETARY_SUPPLEMENT

Pea Protein Isolate, Rice Protein Concentrate, Hemp Protein

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

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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True Nutrition Whey Protein Concentrate True Nutrition Vegan Protein Optimizer Formula

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of the Incarnate Word

OTHER

Sponsor Role lead

Responsible Party

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Brittanie L. Lockard

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Brittanie L Lockard, PhD

Role: PRINCIPAL_INVESTIGATOR

University of the Incarnate Word

Locations

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The University of the Incarnate Word

San Antonio, Texas, United States

Site Status

Countries

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United States

References

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Other Identifiers

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2022-1154-EXP

Identifier Type: -

Identifier Source: org_study_id

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