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 range20 Years – 40 Years
SexALL
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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
✓. 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)
✓
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)
. 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