Your session is about to expire
← Back to Search
Protein Supplement
Whey Protein Supplementation for Food Intolerance
N/A
Waitlist Available
Led By Brittanie L Lockard, PhD
Research Sponsored by University of the Incarnate Word
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 4 weeks, 6 weeks, 10 weeks
Awards & highlights
Study Summary
This trial is testing whether whey protein supplementation affects athletic performance and recovery in people with and without whey protein sensitivity.
Who is the study for?
This trial is for NCAA Division I athletes at the University of the Incarnate Word who have completed a medical history form and are cleared for sports. It's not open to those with diagnosed food allergies, lactose intolerance, or inflammatory bowel diseases like Crohn's.Check my eligibility
What is being tested?
The study aims to find out how common whey protein sensitivity is among these athletes and compare the effects of 4 weeks of supplementation with whey protein versus plant-based proteins (pea, rice, hemp) on their performance and recovery.See study design
What are the potential side effects?
Potential side effects may include digestive discomfort or allergic reactions in those sensitive to whey. Plant-based proteins might also cause gastrointestinal issues depending on individual tolerance.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, 4 weeks, 6 weeks, 10 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 4 weeks, 6 weeks, 10 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change from Baseline InBody Body Composition Test at 4 weeks
Change from Baseline Performance Questionnaire at 4 weeks
Change from Baseline Vertical Jump Test at 4 weeks
Secondary outcome measures
Number of Athletes with Whey Sensitivity
Number of Participants with Declining Measures
Number of Participants with Increasing Measures
Trial Design
3Treatment groups
Experimental Treatment
Active Control
Group I: Whey Protein, Then Plant-based ProteinExperimental Treatment2 Interventions
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 II: Plant-based Protein, Then Whey ProteinExperimental Treatment2 Interventions
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 III: Control Group: Subjects with no protien intakeActive Control1 Intervention
20 subjects will receive no intervention for 10 weeks but complete performance tests and assessments during weeks 0, 4, 6, and 10.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Whey Protein Concentrate
2023
N/A
~20
Find a Location
Who is running the clinical trial?
University of the Incarnate WordLead Sponsor
17 Previous Clinical Trials
2,519 Total Patients Enrolled
Brittanie L Lockard, PhDPrincipal InvestigatorUniversity of the Incarnate Word
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have been diagnosed with a food allergy, lactose intolerance, or a chronic digestive disorder like Crohn's disease, Ulcerative Colitis, or Celiac Sprue.
Research Study Groups:
This trial has the following groups:- Group 1: Plant-based Protein, Then Whey Protein
- Group 2: Control Group: Subjects with no protien intake
- Group 3: Whey Protein, Then Plant-based Protein
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there still opportunities for volunteers to join the experiment?
"Data hosted on clinicaltrials.gov confirms that this experiment is not presently seeking candidates, as it was last updated 19th September 2022. Fortunately, there are 2 other studies which are actively recruiting participants at the moment."
Answered by AI
Recent research and studies
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger