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AzTrials

Protein MetabolismNCT04821557

Effect of Microbial Protease Supplementation on Postprandial Amino Acid Levels

A study testing Protease + Protein in people with Protein Metabolism, run by University of Illinois at Urbana-Champaign at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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). Read more about this study

Who is it for?
Ages 20 to 50 yearsHealthy volunteers can take part
Conditions the study is for
Protein Metabolism
What is being tested?
Protease + Protein
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
24 participants
Where
1 siteUnited States
Study dates
30 Mar 2021to 3 Sep 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 50 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

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

Who cannot join

  • 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)
Show all 25Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Freer Hall; University of Illinois at Urbana-Champaign

    Urbana, Illinois, 61801

Other trials in United States

About this study

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

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.

Being tested
Protease + Protein, Placebo + Protein
Keywords
Protein, Amino Acids, Branched Chain Amino Acids, Leucine, Postprandial

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Protease + ProteinDietary 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 + ProteinDietary supplement

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

Study groups in NCT04821557
Study groupRoleWhat they receive
Microbial Protease SupplementExperimentalA 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.
Receives: Dietary Supplement: Protease + Protein
Placebo (Maltodextrin)Placebo comparatorThe 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.
Receives: Dietary Supplement: Placebo + Protein

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)

    Measured: Five-hours postprandial

  2. 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)

    Measured: Five-hours postprandial

  3. 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)

    Measured: Five-hours postprandial

Secondary outcomes (6)

  1. 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

    Measured: Five-hours postprandial

  2. 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

    Measured: Five-hours postprandial

  3. 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

    Measured: Five-hours postprandial

  4. Plasma Insulin AUC

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

    Measured: Five-hours postprandial

  5. 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.

    Measured: Five-hours postprandial

  6. Gastrointestinal comfort

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

    Measured: Five-hours postprandial

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Mar 2021
  2. Study start30 Mar 2021
  3. Primary completion3 Sep 2021
  4. Study completion3 Sep 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Crossover
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
24 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04821557
Sponsor's protocol ID
21545
Status last verified
Jul 2024
First submitted
22 Mar 2021
Last updated
5 Jul 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 38467279

Questions about this trial

What is this clinical trial studying?

A study testing Protease + Protein in people with Protein Metabolism, run by University of Illinois at Urbana-Champaign at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Total plasma branched chain amino acid(BCAA) area under the curve(AUC) (time frame: Five-hours postprandial). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04821557, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jul 2024.

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