Ignite Creation Date:
2025-12-24 @ 6:36 PM
Ignite Modification Date:
2025-12-28 @ 3:36 PM
Study NCT ID:
NCT04821557
Status:
COMPLETED
Last Update Posted:
2024-07-05
First Post:
2021-03-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Microbial Protease Supplementation on Postprandial Amino Acid Levels
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D010447', 'term': 'Peptide Hydrolases'}, {'id': 'D011506', 'term': 'Proteins'}], 'ancestors': [{'id': 'D006867', 'term': 'Hydrolases'}, {'id': 'D004798', 'term': 'Enzymes'}, {'id': 'D045762', 'term': 'Enzymes and Coenzymes'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': '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.'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-03-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2021-09-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-07-02', 'studyFirstSubmitDate': '2021-03-22', 'studyFirstSubmitQcDate': '2021-03-26', 'lastUpdatePostDateStruct': {'date': '2024-07-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-03-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-09-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Plasma Glucose AUC', 'timeFrame': 'Five-hours postprandial', 'description': '\\<safety outcome\\> Five-hour AUC plasma glucose following a protein shake tolerance test, change from baseline'}], 'primaryOutcomes': [{'measure': 'Total plasma branched chain amino acid(BCAA) area under the curve(AUC)', 'timeFrame': 'Five-hours postprandial', 'description': 'Five-hour area under the curve plasma levels of total BCAA following a protein shake tolerance test, change from baseline\n\nFree leucine, isoleucine, and valine (combined)'}, {'measure': 'Plasma BCAA time-to-peak', 'timeFrame': 'Five-hours postprandial', 'description': 'Time to peak plasma levels of total BCAA following a protein shake tolerance test, change from baseline\n\nTotal of free leucine, isoleucine, and valine (combined)'}, {'measure': 'Plasma BCAA C(MAX)', 'timeFrame': 'Five-hours postprandial', 'description': 'C(MAX) plasma levels of total BCAA levels following a protein shake tolerance test, change from baseline\n\nTotal of free leucine, isoleucine, and valine (combined)'}], 'secondaryOutcomes': [{'measure': 'Plasma essential amino acid (EAA) AUC', 'timeFrame': 'Five-hours postprandial', 'description': 'Five-hour area under the curve plasma levels of total EAA following a protein shake tolerance test, change from baseline\n\nFree leucine, isoleucine, valine, histidine, lysine, methionine, phenylalanine, threonine, tryptophan'}, {'measure': 'Plasma Leucine AUC', 'timeFrame': 'Five-hours postprandial', 'description': 'Five-hour area under the curve plasma levels of total EAA following a protein shake tolerance test, change from baseline\n\nFree leucine'}, {'measure': 'Plasma Total amino acid (AA) AUC', 'timeFrame': 'Five-hours postprandial', 'description': 'Five-hour area under the curve plasma levels of total AA following a protein shake tolerance test, change from baseline\n\nFree leucine, isoleucine, valine, histidine, lysine, methionine, phenylalanine, threonine, tryptophan, arginine, glutamine, glycine, alanine, serine, glutamic acid, aspartic acid, asparagine, tyrosine, cysteine, proline'}, {'measure': 'Plasma Insulin AUC', 'timeFrame': 'Five-hours postprandial', 'description': 'Five-hour AUC plasma insulin following a protein shake tolerance test, change from baseline'}, {'measure': 'Postprandial appetite, hunger, desire-to-eat', 'timeFrame': 'Five-hours postprandial', 'description': '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.'}, {'measure': 'Gastrointestinal comfort', 'timeFrame': 'Five-hours postprandial', 'description': 'Questionnaire (Y/N questions) to determine presence/absence of gastrointestinal discomfort, pain, bloating, and nausea.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Protein', 'Amino Acids', 'Branched Chain Amino Acids', 'Leucine', 'Postprandial'], 'conditions': ['Protein Metabolism']}, 'referencesModule': {'references': [{'pmid': '38467279', 'type': 'RESULT', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.\n\nOral 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged between 20 - 50 years\n* Body mass index = 18.0-29.9 kg∙m-2\n\nExclusion Criteria:\n\n* Age outside of range (20 - 50 y)\n* Pregnancy\n* Subject states they regularly consume probiotic supplements and are unwilling to stop at least one week prior to screening and throughout the study (Supplemental probiotics may include standalone probiotic supplements, vitamins with probiotics, and any foods supplemented with probiotics)\n* Subject states they regularly consume supplemental enzymes and are unwilling to stop at least one week prior to screening and throughout the study (Supplemental enzymes may include standalone enzyme supplements, probiotic supplements with enzymes, and any medications containing enzymes)\n* Abnormality or obstruction of the gastrointestinal tract precluding swallowing (e.g. dysphagia) and digestion (e.g., known intestinal malabsorption, celiac disease, inflammatory bowel disease, chronic pancreatitis, steatorrhea)\n* Diabetes (fasting glucose ≥ 126 mg/dL)\n* Active malignant disease, except basal or squamous cell skin carcinoma or carcinoma in situ of the uterine cervix\n* Liver failure (decompensated chronic liver disease)\n* History of a significant cardiovascular event (e.g., myocardial infarction, heart failure, or stroke) ≤ 3 months prior to the screening visit\n* Subject reports having undergone major surgery less than 6 weeks prior to enrollment in the study, or subject has planned inpatient surgery requiring 2 or more days of hospitalization during the entire study\n* Currently being prescribed (by primary care physician or other health professional) medication or using an over the counter product that in the opinion of the study physician will have an effect on food digestion or nutrient absorption during the study (e.g., prescription orlistat \\[Xenical\\], over the counter orlistat \\[Alli\\])\n* Alcohol intake an average of 3 or more servings per day (a serving defined as 4 oz wine, 12 oz beer, 1 oz spirits)\n* Subject is deemed unsuitable for study based upon study physician assessment\n* Irregular menstrual cycles\n* Participation in other ongoing research that interferes with this study (e.g., conflicting diet, activity interventions, etc.)\n* Any hospitalization or surgery for a metabolic, cardiovascular, or neuromusculoskeletal complication within the past year\n* Allergy or hypersensitivity to latex or adhesives (bandages, medical tape, etc.)\n* Chronic or frequent dizziness/fainting, and arm or leg weakness/numbness\n* Mental Illness\n* Hepatorenal, cardiovascular musculoskeletal, autoimmune, or neurological disease or disorder\n* Consumption of thyroid, androgenic, or other medications known to affect endocrine function\n* Consumption of medications known to affect protein metabolism (e.g., prescription-strength corticosteroids, non-steroidal anti-inflammatories, or acne medication)\n* Unwillingness to comply with study procedures\n* Weight unstable (variation \\>5% of bodyweight in last 6 months)\n* Current or previous tobacco or marijuana use within the last 6 months'}, 'identificationModule': {'nctId': 'NCT04821557', 'briefTitle': 'Effect of Microbial Protease Supplementation on Postprandial Amino Acid Levels', 'organization': {'class': 'OTHER', 'fullName': 'University of Illinois at Urbana-Champaign'}, 'officialTitle': 'Effect of Microbial Protease Supplementation on Postprandial Amino Acid Levels in Healthy Adults', 'orgStudyIdInfo': {'id': '21545'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Microbial Protease Supplement', 'description': '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.', 'interventionNames': ['Dietary Supplement: Protease + Protein']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo (Maltodextrin)', 'description': '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.', 'interventionNames': ['Dietary Supplement: Placebo + Protein']}], 'interventions': [{'name': 'Protease + Protein', 'type': 'DIETARY_SUPPLEMENT', 'description': '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)', 'armGroupLabels': ['Microbial Protease Supplement']}, {'name': 'Placebo + Protein', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Participant will consume a placebo supplement (250 mg maltodextrin) combined with a pea protein beverage (25 g pea protein; Roquette Nutralys® S85F)', 'armGroupLabels': ['Placebo (Maltodextrin)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '61801', 'city': 'Urbana', 'state': 'Illinois', 'country': 'United States', 'facility': 'Freer Hall; University of Illinois at Urbana-Champaign', 'geoPoint': {'lat': 40.11059, 'lon': -88.20727}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Illinois at Urbana-Champaign', 'class': 'OTHER'}, 'collaborators': [{'name': 'BIO-CAT, Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}