Athlete Whey Protein Sensitivity: Prevalence and Performance

NCT05482997 | Completed

• 1 other identifier: 2022-1154-EXP
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Food Intolerance

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (3)

• Number of Participants with Declining Measures

  Baseline, 4 weeks, 6 weeks, 10 weeks

• Number of Participants with Increasing Measures

  Baseline, 4 weeks, 6 weeks, 10 weeks

• Number of Athletes with Whey Sensitivity

  Baseline

Study Arms (3)

Control Group: Subjects with no protien intake

NO INTERVENTION

20 subjects will receive no intervention for 10 weeks but complete performance tests and assessments during weeks 0, 4, 6, and 10.

Whey Protein, Then Plant-based Protein

EXPERIMENTAL

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; Dietary Supplement: Pea Protein Isolate, Rice Protein Concentrate, Hemp Protein

Plant-based Protein, Then Whey Protein

EXPERIMENTAL

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; Dietary Supplement: Pea Protein Isolate, Rice Protein Concentrate, Hemp Protein

Interventions

Whey Protein Concentrate DIETARY_SUPPLEMENT

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

Also known as: True Nutrition Whey Protein Concentrate

Plant-based Protein, Then Whey Protein; Whey Protein, Then Plant-based Protein

Pea Protein Isolate, Rice Protein Concentrate, Hemp Protein DIETARY_SUPPLEMENT

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

Also known as: True Nutrition Vegan Protein Optimizer Formula

Plant-based Protein, Then Whey Protein; Whey Protein, Then Plant-based Protein

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Individuals with a diagnosed food allergy, lactose intolerance, or inflammatory bowel disease (such as Chron's, Ulcerative Colitis, or Celiac Sprue)

Sponsors & Collaborators

• University of the Incarnate Word: lead

Study Sites (1)

The University of the Incarnate Word

San Antonio, Texas, 78209, United States

Location

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MeSH Terms

Conditions

Food Intolerance

Interventions

Whey

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Milk; Beverages; Diet, Food, and Nutrition; Physiological Phenomena; Dairy Products; Food; Food and Beverages

Study Officials

• Brittanie L Lockard, PhD

  University of the Incarnate Word

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: single-blinded (subject only)
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: July 28, 2022
• First Posted: August 1, 2022
• Study Start: January 16, 2023
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: June 5, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)