Effect of Microbial Protease Supplementation on Postprandial Amino Acid Levels

Protein Metabolism Clinical Trial

Official title:

Effect of Microbial Protease Supplementation on Postprandial Amino Acid Levels in Healthy Adults

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04821557
• Other study ID #: 21545
• Status: Completed
• Phase: N/A
• Start date: March 30, 2021
• Est. completion date: September 3, 2021

Study information

• Verified date: February 2021
• Source: University of Illinois at Urbana-Champaign
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: September 3, 2021
• Est. primary completion date: September 3, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Protein Metabolism

Intervention

Dietary Supplement:
• 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)
• Placebo + Protein
Participant will consume a placebo supplement (250 mg maltodextrin) combined with a pea protein beverage (25 g pea protein; Roquette Nutralys® S85F)

Locations

Country	Name	City	State
United States	Freer Hall; University of Illinois at Urbana-Champaign	Urbana	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
University of Illinois at Urbana-Champaign	BIO-CAT Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Plasma Glucose AUC		Five-hours postprandial
Primary	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
Primary	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
Primary	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	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
Secondary	Plasma Leucine AUC	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
Secondary	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
Secondary	Plasma Insulin AUC	Five-hour AUC plasma insulin following a protein shake tolerance test, change from baseline	Five-hours postprandial
Secondary	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
Secondary	Gastrointestinal comfort	Questionnaire (Y/N questions) to determine presence/absence of gastrointestinal discomfort, pain, bloating, and nausea.	Five-hours postprandial