Effects of Microbial Protease Supplementation on Postprandial Plasma Amino Acid Concentrations an… (NCT05957185) | Clinical Trial Compass
CompletedNot Applicable
Effects of Microbial Protease Supplementation on Postprandial Plasma Amino Acid Concentrations and Appetite
Canada24 participantsStarted 2023-08-07
Plain-language 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. 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.
Who can participate
Age range
20 Years – 40 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Early (0-2 h) postprandial plasma total amino acid concentration incremental area-under-the-curve (P3 - WHEY vs. placebo treatment)
. Agree to avoid strenuous exercise 48 hours prior to each visit
. 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
Exclusion criteria
. 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
. 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