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Protein Supplement
Protease + Whey Protein for Digestive Health
N/A
Waitlist Available
Led By Tyler A Churchward-Venne, PhD
Research Sponsored by BIO-CAT, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 72 days
Awards & highlights
Study Summary
This trial tests the effects of microbial proteases & whey protein concentrate on post-meal blood amino acid & glucose levels, gut hormones, appetite & GI tolerability in healthy adults.
Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Potential side effects may include gastrointestinal discomfort such as bloating or gas due to the protease enzyme activity on proteins which could alter digestion patterns for some individuals.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 72 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~72 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Early (0-2 h) postprandial plasma total amino acid concentration incremental area-under-the-curve (P3 - WHEY vs. placebo treatment)
Secondary outcome measures
5-Item Palatability Questionnaire scores
8-Item Modified Gastrointestinal Tolerance Questionnaire scores
Ad libitum meal energy intake
+21 moreTrial Design
2Treatment groups
Active Control
Placebo Group
Group I: P3 - WHEYActive Control1 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: PlaceboPlacebo Group1 Intervention
Maltodextrin from waxy maize at 265 mg per dose.
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Who is running the clinical trial?
BIO-CAT, Inc.Lead Sponsor
4 Previous Clinical Trials
153 Total Patients Enrolled
McGill UniversityOTHER
395 Previous Clinical Trials
999,353 Total Patients Enrolled
Tyler A Churchward-Venne, PhDPrincipal InvestigatorMcGill University
1 Previous Clinical Trials
30 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility 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.You have smoked or used tobacco products in the past 6 months.You follow a diet, like veganism, that does not allow you to eat dairy products.You are known to have a bad reaction or allergy to any of the study products or their ingredients.You have had problems with your liver, gallbladder, or stomach ulcers in the past.You have a history of certain bowel or digestive conditions like irritable bowel disease, inflammatory bowel disease, celiac disease, or gastric ulcers. You have also had intestinal surgery or bariatric surgery in the past.You have a history of unstable thyroid disease, serious mental health issues, weakened immune system, or immune disorders like HIV/AIDS.You have had problems with alcohol or drug abuse, including marijuana, in the past year. This includes being hospitalized for treatment related to substance abuse.You have lost or gained more than 3 kilograms of weight in the 3 months before the study starts.You are willing to continue using cannabinoids (if you already use them) during the study.
Research Study Groups:
This trial has the following groups:- Group 1: P3 - WHEY
- Group 2: Placebo
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does this medical trial seek out participants who are octogenarians?
"According to the requirements of this medical trial, only individuals aged 20 to 40 are eligible for participation."
Answered by AI
Does the protocol allow me to join this experiment?
"Eligibility criteria for this experiment requires participants to have an issue with compulsive eating and be aged between 20-40 years. At the moment, 24 people are being recruited into the trial."
Answered by AI
Are there still slots available for those wishing to take part in this study?
"The particulars on clinicaltrials.gov signify that, as of the moment, this trial is not accepting applicants. It was initially uploaded to the platform in July 1st 2023 and last updated 14 days later; however, there are 12 additional studies currently looking for participants."
Answered by AI
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