Effects of Microbial Protease Supplementation on Postprandial Plasma Amino Acid Concentrations and Appetite

NCT05957185 | Completed

• 2 other identifiers: BCCT-TACV-0010A05-M24-23A
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Digestive Health; Gastrointestinal Health; Appetitive Behavior

Keywords

protease; digestive enzyme; digestion; dietary supplement

Outcome Measures

Primary Outcomes (1)

• Early (0-2 h) postprandial plasma total amino acid concentration incremental area-under-the-curve (P3 - WHEY vs. placebo treatment)

  Free leucine, isoleucine, valine, histidine, lysine, methionine, phenylalanine, threonine, tryptophan, arginine, glutamine, glycine, alanine, serine, glutamic acid, aspartic acid, asparagine, tyrosine, cysteine, proline (combined) (µmol·L\^(-1)·120 min)

  2 hours

Secondary Outcomes (24)

• Early (0-2 h) postprandial plasma essential amino acid concentration incremental area-under-the-curve

  2 hours

• Early (0-2 h) postprandial plasma branched chain amino acid concentration incremental area-under-the-curve

  2 hours

• Early (0-2 h) postprandial plasma leucine concentration incremental area-under-the-curve

  2 hours

• Total (0-4 h) postprandial plasma total amino acid concentration incremental area-under-the-curve

  4 hours

• Total (0-4 h) postprandial plasma essential amino acid concentration incremental area-under-the-curve

  4 hours

Study Arms (2)

P3 - WHEY

ACTIVE COMPARATOR

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.

Dietary Supplement: OPTIZIOME® P³ HYDROLYZER® - WHEY

Placebo

PLACEBO COMPARATOR

Maltodextrin from waxy maize at 265 mg per dose.

Other: Placebo

Interventions

OPTIZIOME® P³ HYDROLYZER® - WHEY DIETARY_SUPPLEMENT

One dose of P3 - WHEY will be combined with 31.9 grams whey protein concentrate in 300 mL water and consumed within 5 minutes at the start of each of the aminoacidemia trials.

Also known as: P3 - WHEY, P3 HYDROLYZER® - WHEY

P3 - WHEY

Placebo OTHER

One dose of placebo maltodextrain will be combined with 31.9 grams whey protein concentrate in 300 mL water and consumed within 5 minutes at the start of each of the aminoacidemia trials.

Placebo

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)
• Willing to maintain current use of cannabinoids (if applicable) throughout the study
• Willing and able to agree to the requirements and restrictions of this study, be willing to give voluntary consent, be able to understand and read the questionnaires, and carry out all study-related procedures

You may not qualify if:

• 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
• Have a history of irritable bowel disease (IBS), inflammatory bowel disease (IBD, including ulcerative colitis and Crohn's disease), functional constipation or diarrhea (defined by the Rome IV diagnostic criteria), celiac disease, malabsorption, gastroparesis, diverticulosis, gastric or duodenal ulcers, pancreatitis, or eating disorder; or have a history of intestinal surgery (excluding appendectomy or herniorrhaphy) or bariatric surgery
• Have an abnormality or obstruction of the gastrointestinal tract precluding swallowing (e.g., dysphagia) and/or digestion (e.g., history of bowel obstruction)
• Participated in upper gastrointestinal endoscopy and/or colonoscopy or preparation within 3 months prior to Visit 2 (Day 1)
• Diagnosed with hypercholesterolemia or hypertriglyceridemia (i.e., elevated fasting low-density lipoprotein (LDL) (≥ 135 mg/dL; ≥ 3.5 mmol/L) or elevated triglycerides (≥ 150 mg/dL; ≥1.7 mmol/L)
• Has a history of heart disease/cardiovascular disease, uncontrolled hypertension (≥ 140 systolic or ≥ 90 diastolic mmHg), kidney disease (dialysis or renal failure), hepatic impairment or disease
• Is Type I or Type II diabetic or pre-diabetic \[i.e., elevated fasting blood glucose levels (≥ 100 mg/dL; ≥ 5.6 mmol/L) and/or elevated hemoglobin A1c (≥ 6.0%)\]
• Has a history of liver or gallbladder disease or stomach ulcers

Sponsors & Collaborators

• BIO-CAT, Inc.: lead
• McGill University: collaborator

Study Sites (1)

McGill University, Currie Gymnasium (Exercise Metabolism and Nutrition Research Laboratory)

Montreal, Quebec, H2W 1S4, Canada

Location

Related Publications (1)

• Huang Y, Bell ZW, Alhamwi A, Sauvageau B, Malenda D, Gardy S, Krauth-Ibarz T, Hannaian SJ, Correa JA, Gritsas A, Garvey SM, Tinker KM, Abou Sawan S, Morais JA, Churchward-Venne TA. Acute Effects of Oral Microbial Protease Co-ingestion with Whey Protein on Postprandial Plasma Amino Acid Concentrations, Appetite, and Satiety in Healthy Adults: A Randomized, Double-Blind, Placebo-Controlled, Crossover Clinical Trial. J Nutr. 2025 Oct;155(10):3356-3373. doi: 10.1016/j.tjnut.2025.07.006. Epub 2025 Jul 15.

  PMID: 40675336 DERIVED

MeSH Terms

Conditions

Appetitive Behavior

Condition Hierarchy (Ancestors)

Behavior, Animal; Behavior

Study Officials

• Tyler A Churchward-Venne, PhD

  McGill University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 14, 2023
• First Posted: July 24, 2023
• Study Start: August 7, 2023
• Primary Completion: January 18, 2024
• Study Completion: January 18, 2024
• Last Updated: January 19, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)