Food IntoleranceNCT05482997
Athlete Whey Protein Sensitivity: Prevalence and Performance
A study testing Whey Protein Concentrate and Pea Protein Isolate, Rice Protein Concentrate, Hemp Protein in people with Food Intolerance, run by University of the Incarnate Word at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Food Intolerance
- What is being tested?
- Whey Protein Concentrate and Pea Protein Isolate, Rice Protein Concentrate, Hemp Protein
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Jan 2023to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Individuals with a diagnosed food allergy, lactose intolerance, or inflammatory bowel disease (such as Chron's, Ulcerative Colitis, or Celiac Sprue)
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of the Incarnate Word
San Antonio, Texas, 78209
About this study
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.
Read the 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.
- Conditions
- Food Intolerance
- Being tested
- Whey Protein Concentrate, Pea Protein Isolate, Rice Protein Concentrate, Hemp Protein
- Medical subject headings
- Food Intolerance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Whey Protein ConcentrateDietary supplement
Also called True Nutrition Whey Protein Concentrate
whey-based protein powder 32g powder mixed with 8-12 oz water
Pea Protein Isolate, Rice Protein Concentrate, Hemp ProteinDietary supplement
Also called True Nutrition Vegan Protein Optimizer Formula
plant-based protein powder. 32g powder mixed with 8-12 oz water
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Dietary Supplement: Whey Protein Concentrate; Dietary Supplement: Pea Protein Isolate, Rice Protein Concentrate, Hemp Protein |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline Performance Questionnaire at 4 weeks
subject assesses food sensitivity symptoms, perceived recovery after athletic event, and satisfaction with athletic performance.
Measured: 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.
Measured: 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.
Measured: Baseline, 4 weeks, 6 weeks, 10 weeks
Secondary outcomes (3)
Number of Participants with Declining Measures
The number of subjects whose self assessment, body composition, and vertical jump depreciate.
Measured: Baseline, 4 weeks, 6 weeks, 10 weeks
Number of Participants with Increasing Measures
The number of subjects whose self assessment, body composition, and vertical jump improve.
Measured: Baseline, 4 weeks, 6 weeks, 10 weeks
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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2022
- Study start16 Jan 2023
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (28)Papers the sponsor has linked to this study.
- Other trials for Food IntoleranceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of the Incarnate Word
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Brittanie L. Lockard, University of the Incarnate Word
- Investigators
- Brittanie L Lockard, PhD, Principal investigator, University of the Incarnate Word
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05482997
- Sponsor's protocol ID
- 2022-1154-EXP
- Status last verified
- Jun 2024
- First submitted
- 28 Jul 2022
- Last updated
- 5 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Boirie Y, Dangin M, Gachon P, Vasson MP, Maubois JL, Beaufrere B. Slow and fast dietary proteins differently modulate postprandial protein accretion. Proc Natl Acad Sci U S A. 1997 Dec 23;94(26):14930-5. doi: 10.1073/pnas.94.26.14930.
PubMed 9405716Zopf Y, Baenkler HW, Silbermann A, Hahn EG, Raithel M. The differential diagnosis of food intolerance. Dtsch Arztebl Int. 2009 May;106(21):359-69; quiz 369-70; 4 p following 370. doi: 10.3238/arztebl.2009.0359. Epub 2009 May 22.
PubMed 19547751Anthoni S, Savilahti E, Rautelin H, Kolho KL. Milk protein IgG and IgA: the association with milk-induced gastrointestinal symptoms in adults. World J Gastroenterol. 2009 Oct 21;15(39):4915-8. doi: 10.3748/wjg.15.4915.
PubMed 19842221Malsagova, K, Stepanov, A, Sinitsyna, AA, Izotov, A, Klyuchnikov, MS, Kopylov, AT, and Kaysheva, AL. Determination of Specific IgG to Identify Possible Food Intolerance in Athletes Using ELISA. Data 6: 122, 2021.
Stockton S, Breshears K, Baker DM. The Impact of a Food Elimination Diet on Collegiate Athletes' 300-meter Run Time and Concentration. Glob Adv Health Med. 2014 Nov;3(6):25-40. doi: 10.7453/gahmj.2014.046.
PubMed 25568830Lee LA, Burks AW. Food allergies: prevalence, molecular characterization, and treatment/prevention strategies. Annu Rev Nutr. 2006;26:539-65. doi: 10.1146/annurev.nutr.26.061505.111211.
PubMed 16602930Ozdemir O, Mete E, Catal F, Ozol D. Food intolerances and eosinophilic esophagitis in childhood. Dig Dis Sci. 2009 Jan;54(1):8-14. doi: 10.1007/s10620-008-0331-x. Epub 2008 Jul 2.
PubMed 18594978Zhou LM, Xu JY, Rao CP, Han S, Wan Z, Qin LQ. Effect of whey supplementation on circulating C-reactive protein: a meta-analysis of randomized controlled trials. Nutrients. 2015 Feb 9;7(2):1131-43. doi: 10.3390/nu7021131.
PubMed 25671415Benjamin J, Makharia G, Ahuja V, Anand Rajan KD, Kalaivani M, Gupta SD, Joshi YK. Glutamine and whey protein improve intestinal permeability and morphology in patients with Crohn's disease: a randomized controlled trial. Dig Dis Sci. 2012 Apr;57(4):1000-12. doi: 10.1007/s10620-011-1947-9. Epub 2011 Oct 26.
PubMed 22038507Antico A, Pagani M, Vescovi PP, Bonadonna P, Senna G. Food-specific IgG4 lack diagnostic value in adult patients with chronic urticaria and other suspected allergy skin symptoms. Int Arch Allergy Immunol. 2011;155(1):52-6. doi: 10.1159/000318736. Epub 2010 Nov 26.
PubMed 21109748Shakoor Z, AlFaifi A, AlAmro B, AlTawil LN, AlOhaly RY. Prevalence of IgG-mediated food intolerance among patients with allergic symptoms. Ann Saudi Med. 2016 Nov-Dec;36(6):386-390. doi: 10.5144/0256-4947.2016.386.
PubMed 27920409de Oliveira EP, Burini RC, Jeukendrup A. Gastrointestinal complaints during exercise: prevalence, etiology, and nutritional recommendations. Sports Med. 2014 May;44 Suppl 1(Suppl 1):S79-85. doi: 10.1007/s40279-014-0153-2.
PubMed 24791919Lambert GP. Intestinal barrier dysfunction, endotoxemia, and gastrointestinal symptoms: the 'canary in the coal mine' during exercise-heat stress? Med Sport Sci. 2008;53:61-73. doi: 10.1159/000151550.
PubMed 19208999Marija, KV, Michalickova D, Dikic N, Stojmenovic T, Andjelkovic M, Nikolik I, Vukasinovic-Vesic M, and Malic T. Food elimination based on immunoglobulin G antibodies improves gastrointestinal discomfort symptoms and sport performance in professional athletes. Med Sport 70: 480-494, 2017.
Jager R, Kerksick CM, Campbell BI, Cribb PJ, Wells SD, Skwiat TM, Purpura M, Ziegenfuss TN, Ferrando AA, Arent SM, Smith-Ryan AE, Stout JR, Arciero PJ, Ormsbee MJ, Taylor LW, Wilborn CD, Kalman DS, Kreider RB, Willoughby DS, Hoffman JR, Krzykowski JL, Antonio J. International Society of Sports Nutrition Position Stand: protein and exercise. J Int Soc Sports Nutr. 2017 Jun 20;14:20. doi: 10.1186/s12970-017-0177-8. eCollection 2017.
PubMed 28642676
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Athlete Whey Protein Sensitivity: Prevalence and Performance
- ClinicalTrials.gov ID
- NCT05482997
- Acronym / sponsor ID
- 2022-1154-EXP
- Conditions
- Food Intolerance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- University of the Incarnate WordUniversity, hospital or other
- Study start
- 16 Jan 2023 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 1 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 | Dietary Supplement: Whey Protein Concentrate, Dietary Supplement: Pea Protein Isolate, Rice Protein Concentrate, Hemp ProteinPerformance 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. |
| Plant-based Protein, Then Whey Protein | Experimental | Dietary Supplement: Whey Protein Concentrate, Dietary Supplement: Pea Protein Isolate, Rice Protein Concentrate, Hemp ProteinPerformance 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- Individuals with a diagnosed food allergy, lactose intolerance, or inflammatory bowel disease (such as Chron's, Ulcerative Colitis, or Celiac Sprue)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Whey Protein ConcentrateAlso: True Nutrition Whey Protein Concentratewhey-based protein powder 32g powder mixed with 8-12 oz water | Dietary supplement | Plant-based Protein, Then Whey Protein, Whey Protein, Then Plant-based Protein |
| Pea Protein Isolate, Rice Protein Concentrate, Hemp ProteinAlso: True Nutrition Vegan Protein Optimizer Formulaplant-based protein powder. 32g powder mixed with 8-12 oz water | Dietary supplement | Plant-based Protein, Then Whey Protein, Whey Protein, Then Plant-based Protein |
Primary outcome
Change from Baseline Performance Questionnaire at 4 weeks
Time frame: Baseline, 4 weeks, 6 weeks, 10 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
Time frame: Baseline, 4 weeks, 6 weeks, 10 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
Time frame: Baseline, 4 weeks, 6 weeks, 10 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.
3 secondary outcomes
Number of Participants with Declining Measures
Time frame: Baseline, 4 weeks, 6 weeks, 10 weeks
Number of Participants with Increasing Measures
Time frame: Baseline, 4 weeks, 6 weeks, 10 weeks
Number of Athletes with Whey Sensitivity
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2024.
- Background: PubMed 9405716Boirie Y, Dangin M, Gachon P, Vasson MP, Maubois JL, Beaufrere B. Slow and fast dietary proteins differently modulate postprandial protein accretion. Proc Natl Acad Sci U S A. 1997 Dec 23;94(26):14930-5. doi: 10.1073/pnas.94.26.14930.
- Background: PubMed 19547751Zopf Y, Baenkler HW, Silbermann A, Hahn EG, Raithel M. The differential diagnosis of food intolerance. Dtsch Arztebl Int. 2009 May;106(21):359-69; quiz 369-70; 4 p following 370. doi: 10.3238/arztebl.2009.0359. Epub 2009 May 22.
- Background: PubMed 19842221Anthoni S, Savilahti E, Rautelin H, Kolho KL. Milk protein IgG and IgA: the association with milk-induced gastrointestinal symptoms in adults. World J Gastroenterol. 2009 Oct 21;15(39):4915-8. doi: 10.3748/wjg.15.4915.
- BackgroundMalsagova, K, Stepanov, A, Sinitsyna, AA, Izotov, A, Klyuchnikov, MS, Kopylov, AT, and Kaysheva, AL. Determination of Specific IgG to Identify Possible Food Intolerance in Athletes Using ELISA. Data 6: 122, 2021.
- Background: PubMed 25568830Stockton S, Breshears K, Baker DM. The Impact of a Food Elimination Diet on Collegiate Athletes' 300-meter Run Time and Concentration. Glob Adv Health Med. 2014 Nov;3(6):25-40. doi: 10.7453/gahmj.2014.046.
- Background: PubMed 16602930Lee LA, Burks AW. Food allergies: prevalence, molecular characterization, and treatment/prevention strategies. Annu Rev Nutr. 2006;26:539-65. doi: 10.1146/annurev.nutr.26.061505.111211.
- Background: PubMed 18594978Ozdemir O, Mete E, Catal F, Ozol D. Food intolerances and eosinophilic esophagitis in childhood. Dig Dis Sci. 2009 Jan;54(1):8-14. doi: 10.1007/s10620-008-0331-x. Epub 2008 Jul 2.
- Background: PubMed 25671415Zhou LM, Xu JY, Rao CP, Han S, Wan Z, Qin LQ. Effect of whey supplementation on circulating C-reactive protein: a meta-analysis of randomized controlled trials. Nutrients. 2015 Feb 9;7(2):1131-43. doi: 10.3390/nu7021131.
- Background: PubMed 22038507Benjamin J, Makharia G, Ahuja V, Anand Rajan KD, Kalaivani M, Gupta SD, Joshi YK. Glutamine and whey protein improve intestinal permeability and morphology in patients with Crohn's disease: a randomized controlled trial. Dig Dis Sci. 2012 Apr;57(4):1000-12. doi: 10.1007/s10620-011-1947-9. Epub 2011 Oct 26.
- Background: PubMed 21109748Antico A, Pagani M, Vescovi PP, Bonadonna P, Senna G. Food-specific IgG4 lack diagnostic value in adult patients with chronic urticaria and other suspected allergy skin symptoms. Int Arch Allergy Immunol. 2011;155(1):52-6. doi: 10.1159/000318736. Epub 2010 Nov 26.
- Background: PubMed 27920409Shakoor Z, AlFaifi A, AlAmro B, AlTawil LN, AlOhaly RY. Prevalence of IgG-mediated food intolerance among patients with allergic symptoms. Ann Saudi Med. 2016 Nov-Dec;36(6):386-390. doi: 10.5144/0256-4947.2016.386.
- Background: PubMed 24791919de Oliveira EP, Burini RC, Jeukendrup A. Gastrointestinal complaints during exercise: prevalence, etiology, and nutritional recommendations. Sports Med. 2014 May;44 Suppl 1(Suppl 1):S79-85. doi: 10.1007/s40279-014-0153-2.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brittanie L Lockard, PhD principal investigator
University of the Incarnate Word
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Whey Protein Concentrate and Pea Protein Isolate, Rice Protein Concentrate, Hemp Protein in people with Food Intolerance, run by University of the Incarnate Word at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline Performance Questionnaire at 4 weeks (time frame: Baseline, 4 weeks, 6 weeks, 10 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05482997, which also lists 28 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2024.