Effect of Microbial Protease Supplementation on Postprandial Amino Acid Levels

NCT04821557 | Completed

• 1 other identifier: 21545
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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

Keywords

Protein; Amino Acids; Branched Chain Amino Acids; Leucine; Postprandial

Outcome Measures

Primary Outcomes (3)

• 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

Secondary Outcomes (6)

• Plasma essential amino acid (EAA) AUC

  Five-hours postprandial

• Plasma Leucine AUC

  Five-hours postprandial

• Plasma Total amino acid (AA) AUC

  Five-hours postprandial

• Plasma Insulin AUC

  Five-hours postprandial

• Postprandial appetite, hunger, desire-to-eat

  Five-hours postprandial

Other Outcomes (1)

• Plasma Glucose AUC

  Five-hours postprandial

Study Arms (2)

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.

Dietary Supplement: Protease + Protein

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.

Dietary Supplement: Placebo + Protein

Interventions

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)

Microbial Protease Supplement

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)

Placebo (Maltodextrin)

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.)

Sponsors & Collaborators

• University of Illinois at Urbana-Champaign: lead
• BIO-CAT, Inc.: collaborator

Study Sites (1)

Freer Hall; University of Illinois at Urbana-Champaign

Urbana, Illinois, 61801, United States

Location

Related Publications (1)

• 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.

  PMID: 38467279 RESULT

MeSH Terms

Interventions

Peptide Hydrolases; Proteins

Intervention Hierarchy (Ancestors)

Hydrolases; Enzymes; Enzymes and Coenzymes; Amino Acids, Peptides, and Proteins

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 22, 2021
• First Posted: March 29, 2021
• Study Start: March 30, 2021
• Primary Completion: September 3, 2021
• Study Completion: September 3, 2021
• Last Updated: July 5, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)