Athlete Whey Protein Sensitivity: Prevalence and Performance
NCT ID: NCT05482997
Last Updated: 2024-06-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
36 participants
INTERVENTIONAL
2023-01-16
2023-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
The Effects of Whey Protein Supplements on Markers of Exercise-induced Muscle Damage in Resistance-trained Individuals
NCT05100459
Effect of Daily Doses of Rice or Whey Protein on Resistance Training Adaptations
NCT04411173
Whole Milk Versus Whey Protein Supplement and Resistance Exercise
NCT01580189
Pea Protein Supplementation and Muscle Damage
NCT03448328
Protein Supplementation and Recovery of Muscle Function
NCT03297151
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
CROSSOVER
SUPPORTIVE_CARE
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
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.
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
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.
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
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Must complete a medical history form
* Must be cleared by sports medicine staff for intercollegiate athletic participation
Exclusion Criteria
18 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University of the Incarnate Word
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Brittanie L. Lockard
Assistant Professor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Brittanie L Lockard, PhD
Role: PRINCIPAL_INVESTIGATOR
University of the Incarnate Word
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
The University of the Incarnate Word
San Antonio, Texas, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Protein Supplements Market Size Report, 2021-2030. 2022, 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.
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.
US BioTek Laboratories, L. See All Our Tests | US BioTek Laboratories, 2022.
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.
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.
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.
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.
Klavora, P. Vertical-jump Tests: A Critical Review. Strength and Conditioning Journal. October 2000 22:5.
Jenni. WHOOP Strain. Retrieved April 22, 2022, from https://support.whoop.com/hc/en-us/articles/360019453214-WHOOP-Strain
Van Deusen, M. Heart Rate Variability | The Ultimate Guide to HRV. 2022, 2021.
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.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2022-1154-EXP
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.