Protease + Whey Protein for Digestive Health

No longer recruiting at 1 trial location

Overseen By Sean M Garvey, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: BIO-CAT, Inc.

Disqualifiers: Pregnancy, Dairy-free diet, COVID-19, others

Compensation: Varies

Number of Visits: 3

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to examine how a combination of enzymes (proteases) and whey protein affects digestion. Researchers seek to determine whether it alters nutrient processing after eating. They also investigate its effects on blood sugar, hunger, and gut health compared to a placebo. Healthy adults comfortable with dairy and maintaining stable health habits might be suitable for this study. As an unphased trial, it offers participants the chance to contribute to foundational research that could enhance understanding of digestion and nutrition.

Will I have to stop taking my current medications?

The trial requires participants to maintain stable use of their current medications and supplements throughout the study, as long as they are defined in the study protocol. It does not specify a need to stop taking any current medications.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that OPTIZIOME® P³ HYDROLYZER® - WHEY, a mix of enzymes and whey protein, improves digestion and protein absorption. Studies found that this combination enhances amino acid absorption after eating, aiding digestion and promoting a feeling of fullness.

Regarding safety, the enzyme blend in OPTIZIOME® is generally well-tolerated, with no major side effects reported in the studies. This suggests it is safe for healthy adults. However, consulting a healthcare professional is advisable if there are any concerns before joining a trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike standard digestive health treatments that often rely on dietary adjustments or medications to aid digestion, OPTIZIOME® P³ HYDROLYZER® - WHEY offers a unique approach by using a mixture of three microbial protease preparations. This treatment specifically targets protein digestion with 50,000 HUT fungal proteolytic activity units per dose, potentially enhancing digestive efficiency more directly than current options. Researchers are particularly excited about this treatment's potential to improve protein breakdown, offering a more targeted solution for individuals struggling with digestive issues related to protein absorption.

What evidence suggests that this trial's treatments could be effective for digestive health?

This trial will compare the effects of OPTIZIOME® P³ HYDROLYZER® - WHEY with a placebo. Studies have shown that OPTIZIOME® P³ HYDROLYZER® - WHEY can enhance protein digestion and increase amino acid levels in the blood after eating. This efficient breakdown of whey protein can aid in muscle repair and growth. Research also suggests that this treatment may help control appetite and increase feelings of fullness, making it easier to manage food intake. Specifically, higher levels of essential amino acids and branched-chain amino acids appeared in the blood 60 minutes after taking the supplement compared to whey protein alone. This suggests the treatment could improve protein absorption and influence appetite in healthy adults. ^{1 2 4 5 6}

Who Is on the Research Team?

Tyler A Churchward-Venne, PhD

Principal Investigator

McGill University

Are You a Good Fit for This Trial?

Healthy adults aged 20-40 with a BMI of 18.5 to 29.9, not on weight loss regimens or having cardiovascular, kidney, liver diseases, or digestive disorders like IBS/IBD. Non-smokers who haven't used tobacco in the last six months and aren't allergic to study products can join if they limit alcohol intake and maintain stable medication/supplement use.

Inclusion Criteria

Healthy adult female or male participants who are 20 to 40 years of age at screening (inclusive)

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 a BMI between 18.5 to 29.9 kg·m^(-2) (inclusive) at Visit 1

Exclusion Criteria

You have recently experienced a bout of stomach or intestinal illness with symptoms like feeling sick to your stomach, throwing up, or having diarrhea within the past two weeks.

You are currently trying to lose weight or planning to start a weight loss program while the study is ongoing.

You have a history of heart or cardiovascular disease, high blood pressure that is not well-controlled, kidney problems requiring dialysis or due to kidney failure, or liver problems.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

Up to 30 days

1 visit (in-person)

Phase 1 Aminoacidemia Trial

Participants receive either microbial proteases or placebo with whey protein concentrate, followed by blood sampling and appetite assessments

1 day

1 visit (in-person)

Washout

A minimum 7-day washout period between treatment phases

7-42 days

Phase 2 Aminoacidemia Trial

Participants receive the alternate treatment (microbial proteases or placebo) with whey protein concentrate, followed by blood sampling and appetite assessments

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• OPTIZIOME® P³ HYDROLYZER® - WHEY
• Placebo

Trial Overview The trial is testing whether adding microbial proteases to whey protein affects amino acid levels in blood after eating compared to just whey protein with placebo. It also looks at how this combination influences blood sugar levels, hunger feelings, hormone regulation of appetite, meal size choices and stomach comfort.

How Is the Trial Designed?

Group I: P3 - WHEY Active Control 1 Intervention

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.

Group II: Placebo Placebo Group 1 Intervention

Maltodextrin from waxy maize at 265 mg per dose.

Who Is Running the Clinical Trial?

BIO-CAT, Inc.

Lead Sponsor

Trials

6

Recruited

210+

McGill University

Collaborator

Trials

421

Recruited

1,017,000+

Citations

1. sciencedirect.com sciencedirect.com/science/article/pii/S0022316625004298

Acute Effects of Oral Microbial Protease Co-ingestion with ... Co-ingestion of WPC with P3 can enhance early postprandial plasma aminoacidemia and alter select indices of appetite and satiety in young adults.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05957185

Study Details | NCT05957185 | Effects of Microbial ... 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 ...

3. jn.nutrition.org jn.nutrition.org/article/S0022-3166(24)00158-5/fulltext

Acute Microbial Protease Supplementation Increases Net ... Microbial protease supplementation may be a strategy for improving protein digestion and subsequent postprandial plasma amino acid availability.

4. withpower.com withpower.com/trial/phase-digestive-health-6-2023-3bf40

Protease + Whey Protein for Digestive Health OPTIZIOME® P³ HYDROLYZER® - WHEY is unique because it combines protease enzymes with whey protein, which may enhance protein digestion and absorption. This ...

5. nutraingredients.com nutraingredients.com/Article/2025/08/07/protease-enzymes-may-enhance-appetite-satiety-effects-of-whey-protein/

Protease enzymes may enhance appetite & satiety effects ... Results showed higher plasma levels of EAAs and BCAAs 60 minutes after consumption of the WPC plus P³ Hydrolyzer, compared to WPC and placebo, ...

6. bio-cat.com bio-cat.com/p3/

OPTIZIOME® P3 HYDROLYZER® OPTIZIOME® P³ HYDROLYZER is an enzyme blend that increases plant and whey protein performance, liberating branched chain amino acids.