Athlete Whey Protein Sensitivity: Prevalence and Performance

Food Intolerance Clinical Trial

Official title:

Athlete Whey Protein Sensitivity: Prevalence and Performance

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05482997
• Other study ID #: 2022-1154-EXP
• Status: Completed
• Phase: N/A
• Start date: January 16, 2023
• Est. completion date: December 31, 2023

Study information

• Verified date: June 2024
• Source: University of the Incarnate Word
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Food Intolerance

Intervention

Dietary Supplement:
• Whey Protein Concentrate
whey-based protein powder 32g powder mixed with 8-12 oz water
• Pea Protein Isolate, Rice Protein Concentrate, Hemp Protein
plant-based protein powder. 32g powder mixed with 8-12 oz water

Locations

Country	Name	City	State
United States	The University of the Incarnate Word	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
University of the Incarnate Word

Country where clinical trial is conducted

United States, 

References & Publications (28)

Anthoni 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. — View Citation

Antico 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. — View Citation

Benjamin 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. — View Citation

Berryhill S, Morton CJ, Dean A, Berryhill A, Provencio-Dean N, Patel SI, Estep L, Combs D, Mashaqi S, Gerald LB, Krishnan JA, Parthasarathy S. Effect of wearables on sleep in healthy individuals: a randomized crossover trial and validation study. J Clin Sleep Med. 2020 May 15;16(5):775-783. doi: 10.5664/jcsm.8356. Epub 2020 Feb 11. — View Citation

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. — View Citation

Bukhari, FK, Fahd, S, Tahira, R, and Yaseen, M. Impact of Sports Anxiety on Sports Performance of Players. Pakistan Journal of Humanities and Social Sciences 9, 2021.

de 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. — View Citation

Garza B, Ege T, Ramos S, Lockard B. Comparison of Actual versus Recommended Intake of Collegiate Athletes Across Gender and Season at a Small Division I University. International Journal of Exercise Science: Conference Proceedings, 2022.

Gorissen SHM, Crombag JJR, Senden JMG, Waterval WAH, Bierau J, Verdijk LB, van Loon LJC. Protein content and amino acid composition of commercially available plant-based protein isolates. Amino Acids. 2018 Dec;50(12):1685-1695. doi: 10.1007/s00726-018-2640-5. Epub 2018 Aug 30. — View Citation

Hooper SL, Mackinnon LT. Monitoring overtraining in athletes. Recommendations. Sports Med. 1995 Nov;20(5):321-7. doi: 10.2165/00007256-199520050-00003. No abstract available. — View Citation

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. — View Citation

Jenni. WHOOP Strain. Retrieved April 22, 2022, from https://support.whoop.com/hc/en-us/articles/360019453214-WHOOP-Strain

Klavora, P. Vertical-jump Tests: A Critical Review. Strength and Conditioning Journal. October 2000 22:5.

Lambert 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. — View Citation

Laurent CM, Green JM, Bishop PA, Sjokvist J, Schumacker RE, Richardson MT, Curtner-Smith M. A practical approach to monitoring recovery: development of a perceived recovery status scale. J Strength Cond Res. 2011 Mar;25(3):620-8. doi: 10.1519/JSC.0b013e3181c69ec6. — View Citation

Lee 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. — View Citation

Lim MT, Pan BJ, Toh DWK, Sutanto CN, Kim JE. Animal Protein versus Plant Protein in Supporting Lean Mass and Muscle Strength: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. Nutrients. 2021 Feb 18;13(2):661. doi: 10.3390/nu13020661. — View Citation

Ling CH, de Craen AJ, Slagboom PE, Gunn DA, Stokkel MP, Westendorp RG, Maier AB. Accuracy of direct segmental multi-frequency bioimpedance analysis in the assessment of total body and segmental body composition in middle-aged adult population. Clin Nutr. 2011 Oct;30(5):610-5. doi: 10.1016/j.clnu.2011.04.001. Epub 2011 May 8. — View Citation

Malsagova, 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.

Marija, 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.

Ozdemir 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. — View Citation

Protein Supplements Market Size Report, 2021-2030. 2022, 2022.

Shakoor 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. — View Citation

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. — View Citation

US BioTek Laboratories, L. See All Our Tests | US BioTek Laboratories, 2022.

Van Deusen, M. Heart Rate Variability | The Ultimate Guide to HRV. 2022, 2021.

Zhou 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. — View Citation

Zopf 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. — View Citation

* Note: There are 28 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	Number of Participants with Declining Measures	The number of subjects whose self assessment, body composition, and vertical jump depreciate.	Baseline, 4 weeks, 6 weeks, 10 weeks
Secondary	Number of Participants with Increasing Measures	The number of subjects whose self assessment, body composition, and vertical jump improve.	Baseline, 4 weeks, 6 weeks, 10 weeks
Secondary	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.	Baseline