Protease + Whey Protein for Digestive Health

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

24 Participants Needed

Trial Summary

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.

What data supports the effectiveness of the treatment OPTIZIOME® P³ HYDROLYZER® - WHEY for digestive health?

Research shows that whey protein, a component of the treatment, has been studied for its potential to improve nutrient absorption and reduce gastrointestinal symptoms. Additionally, a study found that a blend of digestive enzymes with whey protein increased the rate of protein absorption, which could support digestive health. ^{1 2 3 4 5}

Is the combination of protease and whey protein generally safe for human use?

Research suggests that hydrolyzed whey protein, which is broken down by enzymes like protease, may reduce allergenicity compared to regular whey protein. Studies in animals and infants indicate that these hydrolysates are less likely to cause allergic reactions and may be safe for those with milk protein intolerance. ^{6 7 8 9 10}

How is the treatment OPTIZIOME® P³ HYDROLYZER® - WHEY different from other digestive health treatments?

OPTIZIOME® P³ HYDROLYZER® - WHEY is unique because it combines protease enzymes with whey protein, which may enhance protein digestion and absorption. This treatment leverages the benefits of whey protein hydrolysates, which have shown potential in other studies for their protective effects against conditions like colon cancer and their enhanced bioactivity compared to regular whey protein. ^{1 2 11 12 13}

What is the purpose of this trial?

This trial is testing whether adding special enzymes to a protein shake can increase amino acid levels in the blood of healthy adults. The enzymes help break down the protein more efficiently. The study aims to see if this combination works better than just the protein shake alone. The enzymes have been studied for their ability to increase the rate of protein absorption, resulting in higher blood levels of amino acids and reduced levels of certain proteins linked to inflammation.

Research Team

Tyler A Churchward-Venne, PhD

Principal Investigator

McGill University

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

References

1. England pubmed.ncbi.nlm.nih.gov

Different digestion of caprine whey proteins by human and porcine gastrointestinal enzymes. [2018]

2. Spain pubmed.ncbi.nlm.nih.gov

Safe intake of an oral supplement containing carbohydrates and whey protein shortly before sedation to gastroscopy; a double blind, randomized trial. [2015]

3. England pubmed.ncbi.nlm.nih.gov

Bactericidal effect of a whey protein concentrate with anti-Helicobacter pylori activity. [2019]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Peptides surviving the simulated gastrointestinal digestion of milk proteins: biological and toxicological implications. [2015]

5. United States pubmed.ncbi.nlm.nih.gov

A Double-Blind Clinical Study to Investigate the Effects of a Fungal Protease Enzyme System on Metabolic, Hepato-renal, and Cardiovascular Parameters Following 30 Days of Supplementation in Active, Healthy Men. [2021]

6. England pubmed.ncbi.nlm.nih.gov

Increase in degranulation of mucosal mast cells in rats sensitized with milk whey protein hydrolysates compared with native proteins. [2019]

7. Iran pubmed.ncbi.nlm.nih.gov

Effects of enzymatic hydrolysis on the allergenicity of whey protein concentrates. [2018]

8. Korea (South) pubmed.ncbi.nlm.nih.gov

Preparation of Hypoallergenic Whey Protein Hydrolysate by a Mixture of Alcalase and Prozyme and Evaluation of Its Digestibility and Immunoregulatory Properties. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

Whey protein hydrolysate formula for infants with gastrointestinal intolerance to cow milk and soy protein in infant formulas. [2023]

10. United States pubmed.ncbi.nlm.nih.gov

Allergenicity of whey protein: its modification by tryptic in vitro hydrolysis of the protein. [2013]

11. Brazil pubmed.ncbi.nlm.nih.gov

[Influence of proles vegetable enzymes on meat]. [2006]

12. Switzerland pubmed.ncbi.nlm.nih.gov

Whey protein versus whey protein hydrolyzate for the protection of azoxymethane and dextran sodium sulfate induced colonic tumors in rats. [2021]

13. United States pubmed.ncbi.nlm.nih.gov

Inhibitory properties of camel whey protein hydrolysates toward liver cancer cells, dipeptidyl peptidase-IV, and inflammation. [2019]