Effect of Microbial Protease Supplementation on Postprandial Amino Acid Levels

NCT ID: NCT04821557

Last Updated: 2024-07-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-30
• Study Completion Date: 2021-09-03

Brief Summary

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.

Conditions

Protein Metabolism

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: TRIPLE

Study Groups

Microbial Protease Supplement

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.

Group Type: EXPERIMENTAL

Protease + Protein

Intervention Type: 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)

Placebo (Maltodextrin)

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.

Group Type: PLACEBO_COMPARATOR

Placebo + Protein

Intervention Type: DIETARY_SUPPLEMENT

Participant will consume a placebo supplement (250 mg maltodextrin) combined with a pea protein beverage (25 g pea protein; Roquette Nutralys® S85F)

Interventions

Protease + Protein

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)

Intervention Type: DIETARY_SUPPLEMENT

Placebo + Protein

Participant will consume a placebo supplement (250 mg maltodextrin) combined with a pea protein beverage (25 g pea protein; Roquette Nutralys® S85F)

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

• Aged between 20 - 50 years
• Body mass index = 18.0-29.9 kg∙m-2

Exclusion Criteria

• Age outside of range (20 - 50 y)
• Pregnancy
• 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)
• 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)
• 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)
• Diabetes (fasting glucose ≥ 126 mg/dL)
• Active malignant disease, except basal or squamous cell skin carcinoma or carcinoma in situ of the uterine cervix
• Liver failure (decompensated chronic liver disease)
• History of a significant cardiovascular event (e.g., myocardial infarction, heart failure, or stroke) ≤ 3 months prior to the screening visit
• 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
• 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])
• Alcohol intake an average of 3 or more servings per day (a serving defined as 4 oz wine, 12 oz beer, 1 oz spirits)
• Subject is deemed unsuitable for study based upon study physician assessment
• Irregular menstrual cycles
• Participation in other ongoing research that interferes with this study (e.g., conflicting diet, activity interventions, etc.)
• Any hospitalization or surgery for a metabolic, cardiovascular, or neuromusculoskeletal complication within the past year
• Allergy or hypersensitivity to latex or adhesives (bandages, medical tape, etc.)
• Chronic or frequent dizziness/fainting, and arm or leg weakness/numbness
• Mental Illness
• Hepatorenal, cardiovascular musculoskeletal, autoimmune, or neurological disease or disorder
• Consumption of thyroid, androgenic, or other medications known to affect endocrine function
• Consumption of medications known to affect protein metabolism (e.g., prescription-strength corticosteroids, non-steroidal anti-inflammatories, or acne medication)
• Unwillingness to comply with study procedures
• Weight unstable (variation >5% of bodyweight in last 6 months)
• Current or previous tobacco or marijuana use within the last 6 months

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

BIO-CAT, Inc.

INDUSTRY

Sponsor Role: collaborator

University of Illinois at Urbana-Champaign

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Freer Hall; University of Illinois at Urbana-Champaign

Urbana, Illinois, United States

Countries

United States

References

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.

Reference Type: RESULT

PMID: 38467279 (View on PubMed)

Other Identifiers

21545

Identifier Type: -

Identifier Source: org_study_id