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| Name | Class |
|---|---|
| BIO-CAT, Inc. | INDUSTRY |
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Dietary protein is digested in the stomach and intestines to smaller peptides and 20 individual amino acids which, when absorbed by the gut into circulation and taken up by skeletal muscle, help stimulate muscle protein synthesis (MPS). Amino acids also provide the building blocks for muscle proteins that contribute to lean mass gains and increased strength following resistance exercise. Therefore, strategies to efficiently maximize amino acid exposure without overconsumption are warranted.
Oral enzyme supplementation is a candidate approach to optimize amino acid absorption from dietary protein and protein supplements. Microbial proteases, approved for dietary supplement use, can theoretically speed up the conversion of protein and peptides to amino acids. Protease supplements have been marketed to promote muscle strength by optimizing amino acid absorption, however the clinical evidence is limited. This work will support that ingestion of protease supplements with a meal can allow individuals to more efficiently increase amino acid levels from a given amount of dietary protein.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Microbial Protease Supplement | Experimental | A microbial protease supplement (31,875 Hemoglobin Unit Tyrosine base (HUT); protease activity) is taken with a 25g pea protein beverage. The test article will be provided in 250mg capsule form. Capsules will be opened and mixed into protein shake 5 minutes before ingestion. |
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| Placebo (Maltodextrin) | Placebo Comparator | The placebo (maltodextrin) article will be provided in 250mg capsule form. Capsules will be opened and mixed into 25g pea protein shake 5 minutes before ingestion. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Protease + Protein | Dietary Supplement | Participant will consume a microbial protease supplement (31,875 Hemoglobin Unit Tyrosine base (HUT); protease activity) combined with a pea protein beverage (25 g pea protein; Roquette Nutralys® S85F) |
| Measure | Description | Time Frame |
|---|---|---|
| Total plasma branched chain amino acid(BCAA) area under the curve(AUC) | Five-hour area under the curve plasma levels of total BCAA following a protein shake tolerance test, change from baseline Free leucine, isoleucine, and valine (combined) | Five-hours postprandial |
| Plasma BCAA time-to-peak | Time to peak plasma levels of total BCAA following a protein shake tolerance test, change from baseline Total of free leucine, isoleucine, and valine (combined) | Five-hours postprandial |
| Plasma BCAA C(MAX) | C(MAX) plasma levels of total BCAA levels following a protein shake tolerance test, change from baseline Total of free leucine, isoleucine, and valine (combined) | Five-hours postprandial |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma essential amino acid (EAA) AUC | Five-hour area under the curve plasma levels of total EAA following a protein shake tolerance test, change from baseline Free leucine, isoleucine, valine, histidine, lysine, methionine, phenylalanine, threonine, tryptophan | Five-hours postprandial |
| Plasma Leucine AUC |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma Glucose AUC | <safety outcome> Five-hour AUC plasma glucose following a protein shake tolerance test, change from baseline | Five-hours postprandial |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Freer Hall; University of Illinois at Urbana-Champaign | Urbana | Illinois | 61801 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38467279 | Result | Paulussen KJM, Askow AT, Deutz MT, McKenna CF, Garvey SM, Guice JL, Kesler RM, Barnes TM, Tinker KM, Paluska SA, Ulanov AV, Bauer LL, Dilger RN, Burd NA. 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. J Nutr. 2024 May;154(5):1549-1560. doi: 10.1016/j.tjnut.2024.03.009. Epub 2024 Mar 11. |
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| ID | Term |
|---|---|
| D010447 | Peptide Hydrolases |
| D011506 | Proteins |
| ID | Term |
|---|---|
| D006867 | Hydrolases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
| D000602 | Amino Acids, Peptides, and Proteins |
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Supplement and placebo powders will be provided to the clinic in blindly coded containers. The code was generated by parties not responsible for data collection, analysis, or interpretation.
| Placebo + Protein | Dietary Supplement | Participant will consume a placebo supplement (250 mg maltodextrin) combined with a pea protein beverage (25 g pea protein; Roquette Nutralys® S85F) |
|
Five-hour area under the curve plasma levels of total EAA following a protein shake tolerance test, change from baseline Free leucine |
| Five-hours postprandial |
| Plasma Total amino acid (AA) AUC | Five-hour area under the curve plasma levels of total AA following a protein shake tolerance test, change from baseline Free leucine, isoleucine, valine, histidine, lysine, methionine, phenylalanine, threonine, tryptophan, arginine, glutamine, glycine, alanine, serine, glutamic acid, aspartic acid, asparagine, tyrosine, cysteine, proline | Five-hours postprandial |
| Plasma Insulin AUC | Five-hour AUC plasma insulin following a protein shake tolerance test, change from baseline | Five-hours postprandial |
| Postprandial appetite, hunger, desire-to-eat | Visual analog scale questionnaires designed to assess appetite, hunger, desire to eat, administered hourly. Scales from 0 - 100mm. Higher scores indicate higher appetite, hunger or desire to eat. | Five-hours postprandial |
| Gastrointestinal comfort | Questionnaire (Y/N questions) to determine presence/absence of gastrointestinal discomfort, pain, bloating, and nausea. | Five-hours postprandial |