*These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure or prevent any disease.

**BIO-CAT Data on File

†This product is not intended to replace a gluten-free diet or treat or prevent celiac disease.

††According to the AAFCO official publication

A1. Paulussen, K. J. M., Askow, A. T., Deutz, M. T., et al. (2024). Acute Microbial Protease Supplementation Increases Net Postprandial Plasma Amino Acid Concentrations after Pea Protein Ingestion in Healthy Adults: A Randomized, Double-Blind, Placebo-Controlled Trial. The Journal of Nutrition (published online, in press). https://doi.org/10.1016/j.tjnut.2024.03.009

A2. Huang, Yijia et al. “Acute effects of oral microbial protease co-ingestion with whey …” The Journal of nutrition, S0022-3166(25)00429-8. 15 Jul. 2025, doi:10.1016/j.tjnut.2025.07.006

A3. ClinicalTrials.gov. (2023, July 24). Effects of Microbial Protease Supplementation on Postprandial Plasma Amino Acid Concentrations and Appetite. U.S. Department of Health and Human Services, National Institutes of Health, National Library of Medicine. Available online at: https://clinicaltrials.gov/study/NCT05957185

A4. Garvey, S. M., & Tinker, K. M. (2024). P3 HYDROLYZER® Promotes Whey Protein Hy drolysis Cooperatively with Pepsin Under Simulated Oro-Gastric Conditions (BIO-CAT Technical Report No. 0034). BIO-CAT, Inc.

A5. Kerksick, C. M., … Antonio, J. (2017). International Society of Sports Nutrition Position Stand: Nutrient Timing. Journal of the International Society of Sports Nutrition, 14, 33.

A6. Miller, P. E., Alexander, D. D., & Perez, V. (2014). Effects of Whey Protein and Resistance Exercise on Body Composition: A Meta-Analysis of Randomized Controlled Trials. Journal of the American College of Nutrition, 33, 163–175.

A7. Atherton, P. J. et al. Muscle full effect after oral protein: time-dependent concordance and discordance between human muscle protein synthesis and mTORC1 signaling. Am J Clin Nutr 92, 1080–1088 (2010).

A8. Baseline-adjusted TAA

A9. Derived from standard in vitro gastric digestion experiments that showed increased amino acid liberation by P3 HYDROLYZER® compared to two top competitors.

B1. Based on in vitro assays (BIO-CAT Microbials Data on File)

B2. Garvey, S. M., et al. (2022). Gut Microbes, 14(1), 2122668.

B3. Based on in vitro germination analysis in the INFOGEST static gastrointestinal model (BIO-CAT Microbials Data on File).

C1. Garvey, S. M., Blonquist, T. M., Brutscher, L. M., Walsh, D. M., Kaden, V. N., Beckman, D. B., … Spears, J. L. (2025). Dietary Supplementation with the Probiotic Bacillus velezensis BV379 Decreases Abdominal Bloating Without Perturbing the Commensal Gut Microbiota: A Randomized, Double-Blind, Placebo-Controlled Trial in Healthy Adults. Journal of the American Nutrition Association, 1–16. https://doi.org/10.1080/27697061.2025.2563894

C2. Garvey, S. M., … Spears, J. L. (2024, February 7). The Probiotic Bacillus velezensis Strain BV379 Decreases Abdominal Bloating Without Disrupting the Commensal Gut Microbiota: A Randomized, Double-Blind, Placebo-Controlled Trial in Healthy Adults [Poster presentation]. Probiota 2024, Milan, Italy.

D1. Madden, E. N., … Garvey, S. M. (2024). OPTIZIOME® Macro Digest Enhances Macronutrient Hydrolysis Under Simulated Oro-Gastric Conditions that Model Digestive Senescence (BIO-CAT Technical Report No. 0033). BIO-CAT, Inc.

D2. Garvey, S. M., … Tinker, K. M. (2022). Fungal Digestive Enzymes Promote Macronutrient Hydrolysis in the INFOGEST Static In Vitro Simulation of Digestion. Food Chemistry, 386, 132777.

D3. Based on standard in vitro salivary-gastric digestion simulations that showed increased nutrient release with OPTIZIOME® Macro Digest compared to control conditions.

D4. Percentage value represents the relative increase in nutrient release from a standardized test meal by OPTIZIOME® Macro Digest compared to control conditions in a standard in vitro salivary-gastric digestion simulation

D5. Feldman, M., …  Lee, E. (1996). Effects of Aging and Gastritis on Gastric Acid and Pepsin Secretion in Humans: A Prospective Study. Gastroenterology, 110, 1043–1052.

D6. Menard, O., … Dupont, D. (2023). Static In Vitro Digestion Model Adapted to the General Older Adult Population: An INFOGEST International Consensus. Food & Function, 14, 4569–4582.

E1. https://www.futuremarketinsights.com/reports/proton-pump-inhibitors-market

E2. Lomer, M. C. (2015). Review Article: The Aetiology, Diagnosis, Mechanisms and Clinical Evidence for Food Intolerance. Alimentary Pharmacology & Therapeutics, 41(3), 262–275. https://doi.org/10.1111/apt.13041

E3. Ballou, S., Singh, P., Nee, J., et al. (2023). Prevalence and Associated Factors of Bloating: Results From the Rome Foundation Global Epidemiology Study. Gastroenterology, 165(3), 647–655.e4. https://doi.org/10.1053/j.gastro.2023.05.049

E4. Nutrition Business Journal Consumer Survey, powered by the Suzy survey platform. N= 1062 collected week of June 10, 2022. Question: “Do you regularly experience any of the following issues? Please select all that apply.”

F1. Based on responses to the Celiac Symptom Index

F2. Ido H, Matsubara H, Kuroda M, et al. Combination of gluten-digesting enzymes improved symptoms of non-celiac gluten sensitivity: a randomized single-blind, placebo-controlled crossover study. Clinical and Translational Gastroenterology. 2018;9(9):181 https://www.doi.org/10.1038/s41424-018-0052-1

F3. Supported by standard in vitro gastric digestion experiments that showed enhanced amino acid release from whole wheat bread (BIO-CAT Data on File; BCTR0012).

G1. Di Stefano, M., … Corazza, G. R. (2007). The effect of oral alpha-galactosidase on intestinal gas production and gas-related symptoms. Digestive Diseases and Sciences, 52, 78–83.

G2. Di Nardo G, Oliva S, Ferrari F, et al. Efficacy and tolerability of α-galactosidase in treating gas-related symptoms in children: a randomized, double-blind, placebo controlled trial. BMC Gastroenterol. 2013;13:142.

G3. Ganiats TG, Norcross WA, Halverson AL, et al. Does Beano prevent gas? A double-blind crossover study of oral alpha-galactosidase to treat dietary oligosaccharide intolerance. J Fam Pract.  1994;39(5):441-445.

G4. Lettieri JT, Dain B. Effects of beano on the tolerability and pharmacodynamics of acarbose. Clinical Ther. 1998;20(3): 497-504.

H1. Biller J, King S, Rosenthal A, et al. Efficacy of lactase-treated milk for lactose-intolerant pediatric patients. The Journal of pediatrics. 1987;111(1):91-94.

H2. DiPalma J, Collins M. Enzyme replacement for lactose malabsorption using a beta-D-galactosidase. J Clin Gastroenterol. 1989;11(3):290-293.

H3. Lin M, DiPalma J, Martini M, et al. Comparative effects of exogenous lactase (beta-galactosidase) preparations on in vivo lactose digestion. Dig Dis Sci. 1993;38(11):2022-2027.

H4. Kobayashi A, Kawai S, Obe Y, et al. Effects of dietary lactose and lactase preparation on the intestinal absorption of calcium and magnesium in normal infants. Am J Clin Nutr. 1975;28(7):681-683.

H5. Medow M, Thek K, Newman L, et al. Beta-galactosidase tablets in the treatment of lactose intolerance in pediatrics. Am J Dis Child. 1990;144(11):1261-1264.

H6. Xenos K, Kyroudis S, Anagnostidis A, Papastathopoulos P. Treatment of lactose intolerance with exogenous beta-D-galactosidase in pellet form. Eur J Drug Metab Pharmacokinet. 1998;23(2):350-355. doi:10.1007/BF03189363

H7. Medow M, Thek K, Newman L, et al. Beta-galactosidase tablets in the treatment of lactose intolerance in pediatrics. Am J Dis Child. 1990;144(11):1261-1264

H8. S Ho, et al. Comparative effects of A1 versus A2 beta-casein on gastrointestinal measures: a blinded randomized cross-over pilot study. Eur J Clin Nutr.  2014 Sep;68(9):994-1000.

H9. Sun Jianqin, et al. Effects of milk containing only A2 beta casein versus milk containing both A1 and A2 beta casein proteins on gastrointestinal physiology, symptoms of discomfort, and cognitive behavior of people with self-reported intolerance to traditional cows’ milk. Nutr J. 2016 Apr 2;15:35

H10. Rosado, J. L., … Bourges, H. (1984). Enzyme replacement therapy for primary adult lactase deficiency. Gastroenterology, 87, 1072–1082.

H11. https://my.clevelandclinic.org/health/diseases/7317-lactose-intolerance

I1. Fernández-Bañares F. (2022). Carbohydrate Maldigestion and Intolerance. Nutrients, 14, 1923.

I2. Guice, J. L., et al. (2023). Microbial Inulinase Promotes Fructan Hydrolysis Under Simulated Gastric Conditions. Frontiers in Nutrition, 10, 1129329.

I3. Shivakoti, R., et al. (2022). Intake and Sources of Dietary Fiber, Inflammation, and Cardiovascular Disease in Older US Adults. JAMA Network Open, 5, e225012.

I4. Peng, A. W., et al. (2019). Effects of the DASH Diet and Sodium Intake on Bloating: Results From the DASH-Sodium Trial. The American Journal of Gastroenterology, 114, 1109–1115.

I5. Garvey, S. M., et al. (2024). Safety and Tolerability of Microbial Inulinase Supplementation in Healthy Adults: A Randomized, Placebo-Controlled Trial. Gastro Hep Advances, 3, 920–930.

I6. ClinicalTrials.gov. (2024, October 08). The Effects of Oral Fructanase Administration on Gastrointestinal Symptoms After Inulin Challenge in Healthy Adults. U.S. Department of Health and Human Services, National Institutes of Health, National Library of Medicine. https://clinicaltrials.gov/study/NCT06628869

I7. Qu, Y., … Garvey, S. M. (2024). Aspergillus tubingensis Fructanase Promotes Fructan Hydrolysis from Inulin and Oatmeal Under Simulated Oro-Gastric Conditions (BIO-CAT Technical Report No. 0035). BIO-CAT, Inc.

J1. Kallur RK, Madapati S, Mathur A, Bhattacharya S. The role of Weizmannia (Bacillus) coagulans LMG S-31876 in treating IBS-diarrhea. Front Nutr. 2024;10:1310462. Published 2024 Feb 5. doi:10.3389/fnut.2023.1310462

K1. FutureBrand Country Index 2020. FutureBrand examines and ranks consumer brands and country indexes.

L1. Jakhar, et al. Gut Liver 1, 1–8 (2024).

L2. Bastos, T. S. et al. BMC Veterinary Research 16, 1–8 (2020)

L3. Kahraman, O. et al. Research Square (2023).

L4. Paap, P. M. et al. Research Opinions in Animal & Veterinary Sciences (2016).

L5. Félix, A. P. et al. Cienc. Rural (2010).

L6. Schauf, S., et al. Journal of Applied Animal Nutrition (2019).

L7. de Lima, D. C. et al. Animal Feed Science and Technology (2020)

L8. BIO-CAT Microbials Data on File.