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Completed

NCT Number: NCT04821557

Effect of Microbial Protease Supplementation on Postprandial Amino Acid Levels

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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Key information

Conditions

Age range

20 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Freer Hall; University of Illinois at Urbana-Champaign

Urbana, Illinois, 61801, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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)

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)

Primary outcomes

  1. Total plasma branched chain amino acid(BCAA) area under the curve(AUC)

    Time frame: Five-hours postprandial

    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)

  2. Plasma BCAA time-to-peak

    Time frame: Five-hours postprandial

    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)

  3. Plasma BCAA C(MAX)

    Time frame: Five-hours postprandial

    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)

Secondary outcomes

  1. Plasma essential amino acid (EAA) AUC

    Time frame: Five-hours postprandial

    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

  2. Plasma Leucine AUC

    Time frame: Five-hours postprandial

    Five-hour area under the curve plasma levels of total EAA following a protein shake tolerance test, change from baseline

    Free leucine

  3. Plasma Total amino acid (AA) AUC

    Time frame: Five-hours postprandial

    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

  4. Plasma Insulin AUC

    Time frame: Five-hours postprandial

    Five-hour AUC plasma insulin following a protein shake tolerance test, change from baseline

  5. Postprandial appetite, hunger, desire-to-eat

    Time frame: Five-hours postprandial

    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.

  6. Gastrointestinal comfort

    Time frame: Five-hours postprandial

    Questionnaire (Y/N questions) to determine presence/absence of gastrointestinal discomfort, pain, bloating, and nausea.

Other outcomes

  1. Plasma Glucose AUC

    Time frame: Five-hours postprandial

    <safety outcome> Five-hour AUC plasma glucose following a protein shake tolerance test, change from baseline

Sponsors and collaborators

Lead sponsor

University of Illinois at Urbana-Champaign

Other

Collaborators

  • BIO-CAT, Inc.

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Mar 29, 2021
Registry last updated
Jul 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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