Digestive HealthNCT05957185
Effects of Microbial Protease Supplementation on Postprandial Plasma Amino Acid Concentrations and Appetite
A study testing OPTIZIOME® P³ HYDROLYZER® - WHEY in people with Digestive Health and Gastrointestinal Health, run by BIO-CAT, Inc. at 1 site in Canada.
Trial summary
The primary purpose of this study is to assess the effect of co-ingestion of microbial proteases and whey protein concentrate (WPC) on postprandial plasma amino acid concentrations in healthy adult participants compared to WPC with placebo. Read more about this study
- Who is it for?
- Ages 20 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Digestive Health, Gastrointestinal Health, Appetitive Behavior
- What is being tested?
- OPTIZIOME® P³ HYDROLYZER® - WHEY
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteCanada
- Study dates
- 7 Aug 2023to 18 Jan 2024
- 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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy adult female or male participants who are 20 to 40 years of age at screening (inclusive)
- Has a BMI between 18.5 to 29.9 kg·m^(-2) (inclusive) at Visit 1
- In good general health (no uncontrolled diseases or conditions) as deemed by the investigator and able to consume the study product
- Individuals with childbearing potential must agree to practice an acceptable form of birth control (i.e., use for at least 3 months prior to the first dose of study product: hormonal contraceptives including oral contraceptives, hormone birth control patch (e.g., Ortho Evra), or hormone implant (e.g., Norplant System); or condoms)
- Has maintained stable use of medication and supplements defined in the study protocol (Section 7.6), stable dietary and lifestyle habits, and stable body weight, for the last 3 months prior to screening and agree to maintain them throughout the study
- Agree to avoid strenuous exercise 48 hours prior to each visit
Show all 9Show fewer
- Willing to limit daily alcohol consumption to no more than 3 standard drinks per day throughout the study, and agree to entirely avoid alcohol consumption 48 hours prior to each visit (a standard serving is defined here as 4 oz wine, 12 oz beer, 1 oz spirits)
- Willing to maintain current use of cannabinoids (if applicable) throughout the study
- Willing and able to agree to the requirements and restrictions of this study, be willing to give voluntary consent, be able to understand and read the questionnaires, and carry out all study-related procedures
Who cannot join
- Individuals who are lactating, pregnant or planning to become pregnant during the study
- Individual with irregular menstrual cycles (defined as outside 24-38 days cycle range, based on self-reports)
- Individuals who adhere to a diet (e.g., vegan diet) that restricts consumption of dairy products
- Has a known sensitivity, intolerability, or allergy to any of the study products or their excipients
- Weight loss or gain > 3 kg in the 3 months prior to Visit 2 (Day 1)
- Currently or planning to be on a weight loss regimen during the study
Show all 25Show fewer
- Received a vaccine for COVID-19 in the two weeks prior to screening or plans to receive a vaccine for COVID-19 during the study period, currently has COVID-19 or tests positive for COVID-19 within 28 days prior to baseline visit, or currently has any post COVID-19 condition(s) as defined by World Health Organization (WHO) (i.e., individuals with a history of probable or confirmed SARS-CoV-2 infection, usually three months from the onset of COVID-19 with symptoms that last for at least 2 months and cannot be explained by an alternative diagnosis)
- Recent [within 2 weeks of Visit 2 (Day 1)] history of an episode of acute GI illness such as nausea/vomiting or diarrhea
- Have a history of irritable bowel disease (IBS), inflammatory bowel disease (IBD, including ulcerative colitis and Crohn's disease), functional constipation or diarrhea (defined by the Rome IV diagnostic criteria), celiac disease, malabsorption, gastroparesis, diverticulosis, gastric or duodenal ulcers, pancreatitis, or eating disorder; or have a history of intestinal surgery (excluding appendectomy or herniorrhaphy) or bariatric surgery
- Have an abnormality or obstruction of the gastrointestinal tract precluding swallowing (e.g., dysphagia) and/or digestion (e.g., history of bowel obstruction)
- Participated in upper gastrointestinal endoscopy and/or colonoscopy or preparation within 3 months prior to Visit 2 (Day 1)
- Diagnosed with hypercholesterolemia or hypertriglyceridemia (i.e., elevated fasting low-density lipoprotein (LDL) (≥ 135 mg/dL; ≥ 3.5 mmol/L) or elevated triglycerides (≥ 150 mg/dL; ≥1.7 mmol/L)
- Has a history of heart disease/cardiovascular disease, uncontrolled hypertension (≥ 140 systolic or ≥ 90 diastolic mmHg), kidney disease (dialysis or renal failure), hepatic impairment or disease
- Is Type I or Type II diabetic or pre-diabetic [i.e., elevated fasting blood glucose levels (≥ 100 mg/dL; ≥ 5.6 mmol/L) and/or elevated hemoglobin A1c (≥ 6.0%)]
- Has a history of liver or gallbladder disease or stomach ulcers
- Has a positive medical history of unstable thyroid disease, previously diagnosed major affective disorder, psychiatric disorder that required hospitalization in the prior year, immune disorders and/or immunocompromised (e.g., HIV/AIDS)
- Diagnosed with cancer (except localized skin cancer without metastases or in situ cervical cancer) within 5 years prior to the screening visit, or any clinically significant disease or disorder which, in the opinion of the investigator, may either put the potential participant at risk because of participation in the study, or influences the results or the potential participant's ability to participate in the study
- Major surgery in 3 months prior to screening or planned major surgery during the study
- History of alcohol or substance abuse (including cannabinoids) in the 12 months prior to screening (including having been hospitalized for such in an in-patient or out-patient intervention program)
- Use of any treatment listed in the study protocol (Section 7.6) outside of the permitted timeframes and/or conditions.
- Receipt or use of test products in another research study within 30 days prior to Visit 2 or longer if the previous test product is deemed by the investigator to have lasting effects that might influence the eligibility criteria or outcomes of current study
- Current or previous tobacco use within the last 6 months
- Self-report of blood donation totaling between 101 mL to 449 mL of blood within 30 days prior to screening or a blood donation of more than 450 mL within 56 days prior to baseline
- Self-report of donating plasma (e.g., plasmapheresis) within 14 days prior to screening.
- Any other active or unstable medical conditions or use of medications/supplements/therapies that, in the opinion of the investigator, may adversely affect the participant's ability to complete the study or its measures or pose a significant risk to the participant
Trial locations and contacts
1 site in 1 country.
Canada1 site
McGill University, Currie Gymnasium (Exercise Metabolism and Nutrition Research Laboratory)
Montreal, Quebec, H2W 1S4
About this study
Official title: Effects of Oral Microbial Protease Supplementation on Postprandial Plasma Amino Acid Concentrations and Appetite in Healthy Adults: A Randomized, Double-Blind, Placebo-Controlled, Crossover Clinical Trial
The primary purpose of this study is to assess the effect of co-ingestion of microbial proteases and whey protein concentrate (WPC) on postprandial plasma amino acid concentrations in healthy adult participants compared to WPC with placebo. The secondary purpose is to assess the effect of co-ingestion of microbial proteases and WPC on postprandial glycemic response, subjective appetite sensations, gut-derived appetite regulating hormones, ad libitum meal intake, and gastrointestinal tolerability in healthy adult participants compared to WPC with placebo.
Read the detailed description
A within-subject crossover design will be used for this randomized, double-blind, placebo-controlled study in health adults to assess the efficacy of a microbial protease mixture (from Aspergillus species) on enhancing postprandial aminoacidemia after consumption of a whey protein shake. There are two treatment groups in this crossover trial, including one microbial protease group and one placebo group. A total of 24 participants will be enrolled and undergo both treatment phases with a minimum 7-day washout.
The study will last no less than 8 days and up to 72 days for each participant, including screening, washout, and end of study (EOS) visit. The study will include a screening visit (Visit 1) followed by a screening period lasting up to 30 days, the phase 1 aminoacidemia trial on Day 1 (Visit 2), minimum 7-day washout with a window of +35 days, followed by the phase 2 aminoacidemia trial (EOS Visit 3, Day 8 +35 days).
During the aminoacidemia trials, participants will arrive to the clinic in a fasted state, and 31.9 grams whey protein concentrate (WPC) in 300 mL water with microbial proteases or placebo will be administered. Blood will be collected at baseline and 11 postprandial timepoints across 4 hours for plasma amino acid, glucose, and insulin quantitation. Blood will also be utilized for quantitation of the anorexigenic, satiety-related peptide hormones glucagon-like peptide 1 (GLP-1) and peptide YY (PYY), and the orexigenic peptide hormone ghrelin.
Additionally, changes in appetite sensations will be assessed by visual analog score (VAS) responses to 5 questions at baseline, directly after consumption of study products, and postprandially every half hour. Palatability of the study products will be assessed by 5-item Palatability Questionnaire. Gastrointestinal tolerability will be assessed by 8-item modified Gastrointestinal Tolerance Questionnaire (mGITQ) at the end of the 4-hour aminoacidemia trial.
To further investigate appetite and satiety, an test meal will be provided at 4 hours for the determination of energy intake, followed by a final appetite VAS questionnaire immediately after the test meal. The maximum time to finish the test meal is 30 minutes.
To account for the potential influence of menstrual cycle timing on the outcomes of interest, female subjects will be instructed to contact the clinic on day 1 of their menses so that Visit 2 (Day 1) can be scheduled at the end of menses, but still during the follicular phase of their menstrual cycle. The follicular phase is defined as days 1-14, where day 1 is the first day of menses. Therefore, Visit 2 (Day 1) and Visit 3 for female participants will occur approximately 3-5 days after start of menses, but on or before day 14 of the follicular phase (+4 day window), unless Visit 3 can be scheduled within the same follicular phase as Visit 2, with an at least 7-day washout.
The study will include a total of three in-person visit days: screening (Visit 1), phase 1 (Visit 2), and phase 2/EOS (Visit 3). Study endpoints include postprandial plasma amino acid concentrations, postprandial plasma glucose and insulin concentrations, and postprandial plasma GLP-1, PYY, and ghrelin concentrations. Endpoints also include appetite VAS scores, ad libitum meal consumption, mGITQ scores, vital signs, anthropometric measures, and reports of adverse events, which will be assessed at all clinic visits.
- Being tested
- OPTIZIOME® P³ HYDROLYZER® - WHEY, Placebo
- Keywords
- protease, digestive enzyme, digestion, dietary supplement
- Medical subject headings
- Appetitive Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OPTIZIOME® P³ HYDROLYZER® - WHEYDietary supplement
Also called P3 - WHEY, P3 HYDROLYZER® - WHEY
One dose of P3 - WHEY will be combined with 31.9 grams whey protein concentrate in 300 mL water and consumed within 5 minutes at the start of each of the aminoacidemia trials.
PlaceboOther
One dose of placebo maltodextrain will be combined with 31.9 grams whey protein concentrate in 300 mL water and consumed within 5 minutes at the start of each of the aminoacidemia trials.
| Study group | Role | What they receive |
|---|---|---|
| P3 - WHEY | Active comparator | OPTIZIOME® P3 HYDROLYZER® - WHEY (P3 - WHEY) is a mixture of 3 microbial protease preparations with 50,000 HUT fungal proteolytic activity units per 250 mg dose. Receives: Dietary Supplement: OPTIZIOME® P³ HYDROLYZER® - WHEY |
| Placebo | Placebo comparator | Maltodextrin from waxy maize at 265 mg per dose. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Early (0-2 h) postprandial plasma total amino acid concentration incremental area-under-the-curve (P3 - WHEY vs. placebo treatment)
Free leucine, isoleucine, valine, histidine, lysine, methionine, phenylalanine, threonine, tryptophan, arginine, glutamine, glycine, alanine, serine, glutamic acid, aspartic acid, asparagine, tyrosine, cysteine, proline (combined) (µmol·L^(-1)·120 min)
Measured: 2 hours
Secondary outcomes (24)
Early (0-2 h) postprandial plasma essential amino acid concentration incremental area-under-the-curve
Free leucine, isoleucine, valine, histidine, lysine, methionine, phenylalanine, threonine, tryptophan (combined) (µmol·L^(-1)·120 min)
Measured: 2 hours
Early (0-2 h) postprandial plasma branched chain amino acid concentration incremental area-under-the-curve
Free leucine, isoleucine, valine (combined) (µmol·L^(-1)·120 min)
Measured: 2 hours
Early (0-2 h) postprandial plasma leucine concentration incremental area-under-the-curve
Free leucine (µmol·L^(-1)·120 min)
Measured: 2 hours
Total (0-4 h) postprandial plasma total amino acid concentration incremental area-under-the-curve
Free leucine, isoleucine, valine, histidine, lysine, methionine, phenylalanine, threonine, tryptophan, arginine, glutamine, glycine, alanine, serine, glutamic acid, aspartic acid, asparagine, tyrosine, cysteine, proline (combined) (µmol·L^(-1)·240 min)
Measured: 4 hours
Total (0-4 h) postprandial plasma essential amino acid concentration incremental area-under-the-curve
Free leucine, isoleucine, valine, histidine, lysine, methionine, phenylalanine, threonine, tryptophan (combined) (µmol·L^(-1)·240 min)
Measured: 4 hours
Total (0-4 h) postprandial plasma branched chain amino acid concentration incremental area-under-the-curve
Free leucine, isoleucine, valine (combined) (µmol·L^(-1)·240 min)
Measured: 4 hours
Total (0-4 h) postprandial plasma leucine concentration incremental area-under-the-curve
Free leucine (µmol·L^(-1)·240 min)
Measured: 4 hours
Postprandial plasma amino acid concentration, absolute change from baseline to 45 minutes
Total amino acids, essential amino acids, branched chain amino acids, leucine (µmol/L)
Measured: 45 minutes
Postprandial plasma amino acid concentration, baseline-adjusted change from baseline to 45 minutes
Total amino acids, essential amino acids, branched chain amino acids, leucine (µmol/L)
Measured: 45 minutes
Postprandial plasma amino acid concentration, absolute change from baseline to 60 minutes
Total amino acids, essential amino acids, branched chain amino acids, leucine (µmol/L)
Measured: 60 minutes
Postprandial plasma amino acid concentration, baseline-adjusted change from baseline to 60 minutes
Total amino acids, essential amino acids, branched chain amino acids, leucine (µmol/L)
Measured: 60 minutes
Postprandial plasma amino acid maximum concentration
Total amino acids, essential amino acids, branched chain amino acids, leucine (µmol/L)
Measured: 4 hours
Postprandial plasma amino acid time to peak concentration
Total amino acids, essential amino acids, branched chain amino acids, leucine (minutes)
Measured: 4 hours
Postprandial plasma glucose concentration incremental area-under-the-curve
Plasma glucose (mmol·L^(-1)·240 min)
Measured: 4 hours
Postprandial plasma insulin concentration incremental area-under-the-curve
Plasma insulin (mmol·L^(-1)·240 min)
Measured: 4 hours
Postprandial appetite sensation scores
Participants will be asked to complete visual analog scales (VAS) for measurements of appetite sensations at 10 timepoints (t = 0, 30, 60, 90, 120, 150, 180, 210, 240, and 270 min). Five sensations related to appetite are queried by VAS (i.e., "How hungry are you?", "How full are you?", "How satiated are you?", "How strong is your desire to eat?" on a scale from "Not at all" to "Extremely"; and "How much do you think you could (or would want to) eat right now" on a scale from "nothing at all" to "a very large amount"). Outcomes are measured in millimeters (mm) along a 100-mm horizontal line.
Measured: 4.5 hours
Postprandial appetite sensation incremental-area-under-the-curve
Participants will be asked to complete visual analog scales (VAS) for measurements of appetite sensations at 9 timepoints (t = 0, 30, 60, 90, 120, 150, 180, 210, 240). Five sensations related to appetite are queried by VAS (i.e., "How hungry are you?", "How full are you?", "How satiated are you?", "How strong is your desire to eat?" on a scale from "Not at all" to "Extremely"; and "How much do you think you could (or would want to) eat right now" on a scale from "nothing at all" to "a very large amount"). Responses are measured in mm·240 min.
Measured: 4 hours
Total (0-4 h) postprandial plasma glucagon-like peptide 1 incremental-area-under-the-curve
Plasma glucagon-like peptide 1 (pg ·L^(-1)·240 min)
Measured: 4 hours
Total (0-4 h) postprandial plasma peptide YY incremental-area-under-the-curve
Plasma peptide YY (pg·L^(-1)·240 min)
Measured: 4 hours
Total (0-4 h) postprandial plasma ghrelin incremental-area-under-the-curve
Plasma ghrelin (pg·L^(-1)·240 min)
Measured: 4 hours
Ad libitum meal energy intake
The ad libitum test meal will contain 562 kJ per 100 g with 20% energy from protein, 65% energy from carbohydrate, and 15% energy from fat. The participants will be provided with approximately 1 kg of the test meal on a plate with utensils. Participants will be instructed to "eat as much or as little as desired until feeling "comfortably full" within 30 minutes. The meal will be weighed before consumption and remaining contents will be weighed after achieving comfortable fullness to calculate the energy intake. The outcome will be measure in kilojoules (kJ).
Measured: 4.5 hours
5-Item Palatability Questionnaire scores
Visual analog score (VAS) outcomes are measured in millimeters (mm) along a 100-mm horizontal line. The most positive and most negative ratings are anchored at each end of the line. The VAS statements on palatability include: (1) "Visual appeal". Responses can range from "Good" to "Bad"; (2) "Smell". Responses can range from "Good" to "Bad"; (3) "Taste". Responses can range from "Good" to "Bad"; (4) "Aftertaste". Responses can range from "Much" to "None"; and (5) "Palatability". Responses can range from "Good" to "Bad".
Measured: 4 hours
8-Item Modified Gastrointestinal Tolerance Questionnaire scores
Participants will be asked to complete an 8-item modified Gastrointestinal Tolerance Questionnaire at the conclusion of each aminoacidemia trial (t = 4 hours). Gastrointestinal symptoms including abdominal bloating/distension, burping, gas/flatulence, borborygmus/stomach rumbling, abdominal cramping, reflux (heartburn), nausea, and vomiting, will be ranked on a 4-point scale ranging from "none" to "severe".
Measured: 4 hours
Incidence of adverse events
Number of participants with adverse events
Measured: 72 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2023
- Study start7 Aug 2023
- Primary completion18 Jan 2024
- Study completion18 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Digestive HealthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- BIO-CAT, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- McGill University
- Responsible party
- Sponsor
- Investigators
- Tyler A Churchward-Venne, PhD, Principal investigator, McGill University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05957185
- Sponsor's protocol ID
- BCCT-TACV-0010
- Other IDs
- A05-M24-23A
- Status last verified
- Jan 2024
- First submitted
- 14 Jul 2023
- Last updated
- 19 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Huang Y, Bell ZW, Alhamwi A, Sauvageau B, Malenda D, Gardy S, Krauth-Ibarz T, Hannaian SJ, Correa JA, Gritsas A, Garvey SM, Tinker KM, Abou Sawan S, Morais JA, Churchward-Venne TA. Acute Effects of Oral Microbial Protease Co-ingestion with Whey Protein on Postprandial Plasma Amino Acid Concentrations, Appetite, and Satiety in Healthy Adults: A Randomized, Double-Blind, Placebo-Controlled, Crossover Clinical Trial. J Nutr. 2025 Oct;155(10):3356-3373. doi: 10.1016/j.tjnut.2025.07.006. Epub 2025 Jul 15.
PubMed 40675336
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Oral Microbial Protease Supplementation on Postprandial Plasma Amino Acid Concentrations and Appetite in Healthy Adults: A Randomized, Double-Blind, Placebo-Controlled, Crossover Clinical Trial
- ClinicalTrials.gov ID
- NCT05957185
- Acronym / sponsor ID
- BCCT-TACV-0010
- Keywords
- protease, digestive enzyme, digestion, dietary supplement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- BIO-CAT, Inc.Industry (pharma, biotech, devices)
- Collaborators
- McGill University
- Study start
- 7 Aug 2023 (actual)
- Primary completion
- 18 Jan 2024 (actual)
- Study completion
- 18 Jan 2024 (actual)
- First posted
- 24 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary purpose of this study is to assess the effect of co-ingestion of microbial proteases and whey protein concentrate (WPC) on postprandial plasma amino acid concentrations in healthy adult participants compared to WPC with placebo. The secondary purpose is to assess the effect of co-ingestion of microbial proteases and WPC on postprandial glycemic response, subjective appetite sensations, gut-derived appetite regulating hormones, ad libitum meal intake, and gastrointestinal tolerability in healthy adult participants compared to WPC with placebo.
Detailed description
A within-subject crossover design will be used for this randomized, double-blind, placebo-controlled study in health adults to assess the efficacy of a microbial protease mixture (from Aspergillus species) on enhancing postprandial aminoacidemia after consumption of a whey protein shake. There are two treatment groups in this crossover trial, including one microbial protease group and one placebo group. A total of 24 participants will be enrolled and undergo both treatment phases with a minimum 7-day washout.
The study will last no less than 8 days and up to 72 days for each participant, including screening, washout, and end of study (EOS) visit. The study will include a screening visit (Visit 1) followed by a screening period lasting up to 30 days, the phase 1 aminoacidemia trial on Day 1 (Visit 2), minimum 7-day washout with a window of +35 days, followed by the phase 2 aminoacidemia trial (EOS Visit 3, Day 8 +35 days).
During the aminoacidemia trials, participants will arrive to the clinic in a fasted state, and 31.9 grams whey protein concentrate (WPC) in 300 mL water with microbial proteases or placebo will be administered. Blood will be collected at baseline and 11 postprandial timepoints across 4 hours for plasma amino acid, glucose, and insulin quantitation. Blood will also be utilized for quantitation of the anorexigenic, satiety-related peptide hormones glucagon-like peptide 1 (GLP-1) and peptide YY (PYY), and the orexigenic peptide hormone ghrelin.
Additionally, changes in appetite sensations will be assessed by visual analog score (VAS) responses to 5 questions at baseline, directly after consumption of study products, and postprandially every half hour. Palatability of the study products will be assessed by 5-item Palatability Questionnaire. Gastrointestinal tolerability will be assessed by 8-item modified Gastrointestinal Tolerance Questionnaire (mGITQ) at the end of the 4-hour aminoacidemia trial.
To further investigate appetite and satiety, an test meal will be provided at 4 hours for the determination of energy intake, followed by a final appetite VAS questionnaire immediately after the test meal. The maximum time to finish the test meal is 30 minutes.
To account for the potential influence of menstrual cycle timing on the outcomes of interest, female subjects will be instructed to contact the clinic on day 1 of their menses so that Visit 2 (Day 1) can be scheduled at the end of menses, but still during the follicular phase of their menstrual cycle. The follicular phase is defined as days 1-14, where day 1 is the first day of menses. Therefore, Visit 2 (Day 1) and Visit 3 for female participants will occur approximately 3-5 days after start of menses, but on or before day 14 of the follicular phase (+4 day window), unless Visit 3 can be scheduled within the same follicular phase as Visit 2, with an at least 7-day washout.
The study will include a total of three in-person visit days: screening (Visit 1), phase 1 (Visit 2), and phase 2/EOS (Visit 3). Study endpoints include postprandial plasma amino acid concentrations, postprandial plasma glucose and insulin concentrations, and postprandial plasma GLP-1, PYY, and ghrelin concentrations. Endpoints also include appetite VAS scores, ad libitum meal consumption, mGITQ scores, vital signs, anthropometric measures, and reports of adverse events, which will be assessed at all clinic visits.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| P3 - WHEY | Active comparator | Dietary Supplement: OPTIZIOME® P³ HYDROLYZER® - WHEYOPTIZIOME® P3 HYDROLYZER® - WHEY (P3 - WHEY) is a mixture of 3 microbial protease preparations with 50,000 HUT fungal proteolytic activity units per 250 mg dose. |
| Placebo | Placebo comparator | Other: PlaceboMaltodextrin from waxy maize at 265 mg per dose. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Healthy adult female or male participants who are 20 to 40 years of age at screening (inclusive)
- Has a BMI between 18.5 to 29.9 kg·m^(-2) (inclusive) at Visit 1
- In good general health (no uncontrolled diseases or conditions) as deemed by the investigator and able to consume the study product
- Individuals with childbearing potential must agree to practice an acceptable form of birth control (i.e., use for at least 3 months prior to the first dose of study product: hormonal contraceptives including oral contraceptives, hormone birth control patch (e.g., Ortho Evra), or hormone implant (e.g., Norplant System); or condoms)
- Has maintained stable use of medication and supplements defined in the study protocol (Section 7.6), stable dietary and lifestyle habits, and stable body weight, for the last 3 months prior to screening and agree to maintain them throughout the study
Key exclusion criteria (25 listed)
- Individuals who are lactating, pregnant or planning to become pregnant during the study
- Individual with irregular menstrual cycles (defined as outside 24-38 days cycle range, based on self-reports)
- Individuals who adhere to a diet (e.g., vegan diet) that restricts consumption of dairy products
- Has a known sensitivity, intolerability, or allergy to any of the study products or their excipients
- Weight loss or gain > 3 kg in the 3 months prior to Visit 2 (Day 1)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OPTIZIOME® P³ HYDROLYZER® - WHEYAlso: P3 - WHEY, P3 HYDROLYZER® - WHEYOne dose of P3 - WHEY will be combined with 31.9 grams whey protein concentrate in 300 mL water and consumed within 5 minutes at the start of each of the aminoacidemia trials. | Dietary supplement | P3 - WHEY |
| PlaceboOne dose of placebo maltodextrain will be combined with 31.9 grams whey protein concentrate in 300 mL water and consumed within 5 minutes at the start of each of the aminoacidemia trials. | Other | Placebo |
Primary outcome
Early (0-2 h) postprandial plasma total amino acid concentration incremental area-under-the-curve (P3 - WHEY vs. placebo treatment)
Time frame: 2 hours
Free leucine, isoleucine, valine, histidine, lysine, methionine, phenylalanine, threonine, tryptophan, arginine, glutamine, glycine, alanine, serine, glutamic acid, aspartic acid, asparagine, tyrosine, cysteine, proline (combined) (µmol·L^(-1)·120 min)
24 secondary outcomes
Early (0-2 h) postprandial plasma essential amino acid concentration incremental area-under-the-curve
Time frame: 2 hours
Early (0-2 h) postprandial plasma branched chain amino acid concentration incremental area-under-the-curve
Time frame: 2 hours
Early (0-2 h) postprandial plasma leucine concentration incremental area-under-the-curve
Time frame: 2 hours
Total (0-4 h) postprandial plasma total amino acid concentration incremental area-under-the-curve
Time frame: 4 hours
Total (0-4 h) postprandial plasma essential amino acid concentration incremental area-under-the-curve
Time frame: 4 hours
Total (0-4 h) postprandial plasma branched chain amino acid concentration incremental area-under-the-curve
Time frame: 4 hours
Total (0-4 h) postprandial plasma leucine concentration incremental area-under-the-curve
Time frame: 4 hours
Postprandial plasma amino acid concentration, absolute change from baseline to 45 minutes
Time frame: 45 minutes
Postprandial plasma amino acid concentration, baseline-adjusted change from baseline to 45 minutes
Time frame: 45 minutes
Postprandial plasma amino acid concentration, absolute change from baseline to 60 minutes
Time frame: 60 minutes
Postprandial plasma amino acid concentration, baseline-adjusted change from baseline to 60 minutes
Time frame: 60 minutes
Postprandial plasma amino acid maximum concentration
Time frame: 4 hours
Postprandial plasma amino acid time to peak concentration
Time frame: 4 hours
Postprandial plasma glucose concentration incremental area-under-the-curve
Time frame: 4 hours
Postprandial plasma insulin concentration incremental area-under-the-curve
Time frame: 4 hours
Postprandial appetite sensation scores
Time frame: 4.5 hours
Postprandial appetite sensation incremental-area-under-the-curve
Time frame: 4 hours
Total (0-4 h) postprandial plasma glucagon-like peptide 1 incremental-area-under-the-curve
Time frame: 4 hours
Total (0-4 h) postprandial plasma peptide YY incremental-area-under-the-curve
Time frame: 4 hours
Total (0-4 h) postprandial plasma ghrelin incremental-area-under-the-curve
Time frame: 4 hours
Ad libitum meal energy intake
Time frame: 4.5 hours
5-Item Palatability Questionnaire scores
Time frame: 4 hours
8-Item Modified Gastrointestinal Tolerance Questionnaire scores
Time frame: 4 hours
Incidence of adverse events
Time frame: 72 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2024.
- Derived from this study: PubMed 40675336Huang Y, Bell ZW, Alhamwi A, Sauvageau B, Malenda D, Gardy S, Krauth-Ibarz T, Hannaian SJ, Correa JA, Gritsas A, Garvey SM, Tinker KM, Abou Sawan S, Morais JA, Churchward-Venne TA. Acute Effects of Oral Microbial Protease Co-ingestion with Whey Protein on Postprandial Plasma Amino Acid Concentrations, Appetite, and Satiety in Healthy Adults: A Randomized, Double-Blind, Placebo-Controlled, Crossover Clinical Trial. J Nutr. 2025 Oct;155(10):3356-3373. doi: 10.1016/j.tjnut.2025.07.006. Epub 2025 Jul 15.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tyler A Churchward-Venne, PhD principal investigator
McGill University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing OPTIZIOME® P³ HYDROLYZER® - WHEY in people with Digestive Health and Gastrointestinal Health, run by BIO-CAT, Inc. at 1 site in Canada.
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 9 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 19 Jan 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 Canada. 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?
Early (0-2 h) postprandial plasma total amino acid concentration incremental area-under-the-curve (P3 - WHEY vs. placebo treatment) (time frame: 2 hours). 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 NCT05957185, 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 19 Jan 2024.