Clinical Trial on Digestive Enzymes: Effects on Post-Meal Response to High-Macronutrient Meals

NCT06949735 | Completed Phase 2

• 1 other identifier: P02-24-01-T0074
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to show how digestive enzyme supplements help the body break down fats, proteins, and carbohydrates, especially after eating a high-macronutrient meal. Digestive enzymes are essential for nutrient absorption, but some people-such as those with certain medical conditions or high-protein diets-may not produce enough on their own. Poor digestion can lead to bloating, discomfort, and gut imbalances. This clinical trial tests a delayed-release, porcine-derived enzyme blend to see if it improves digestion and reduces symptoms like bloating and gas after eating a high-macronutrient meal.

Conditions

Healthy; Gastrointestinal Wellbeing; Gastrointestinal Supplements; Gastrointestinal Digestion

Keywords

Digestive enzyme; Gastrointestinal; Digestion; High-macronutrient meal

Outcome Measures

Primary Outcomes (1)

• To Assess the effect of the TP on lipid digestion after a single dose using area under the curve (AUC0-t) - Total Triglycerides

  Comparison of total Triglycerides (TG) up to 360 min in response to the high-macronutrient meal.

  30,60,90,120,180,210,240,270,300,330 and 360 minutes

Secondary Outcomes (15)

• To assess the effect of the TP on lipid digestion after a single dose using maximum concentration (Cmax): Total Triglycerides

  30,60,90,120,180,210,240,270,300,330 and 360 minutes

• To assess the effect of the TP on lipid digestion after a single dose using time to reach maximum concentration (Tmax) - Total Triglycerides

  30,60,90,120,180,210,240,270,300,330 and 360 minutes

• To assess the effect of the TP on protein digestion after a single dose using area under the curve (AUC0-t):Total Free Amino Acids (TFAA)

  30,45,60,75,90,105,120,150,180,210,240,270,300,330,360 minutes

• To assess the effect of the TP on protein digestion after a single dose using maximum concentration (Cmax):Total Free Amino Acids(TFAA)

  30,45,60,75,90,105,120,150,180,210,240,270,300,330,360 minutes

• To assess the effect of the TP on protein digestion after a single dose using time to reach maximum concentration (Tmax):Total Free Amino Acids(TFAA)

  30,45,60,75,90,105,120,150,180,210,240,270,300,330,360 minutes

Other Outcomes (1)

• To assess the safety of the TP

  8 weeks

Study Arms (2)

Digestive Enzyme Blend

ACTIVE COMPARATOR

Active ingredients: Porcine Pancreatic Enzyme

Dietary Supplement: Digestive Enzyme Blend

Placebo

PLACEBO COMPARATOR

Active ingredients: None

Dietary Supplement: Placebo

Interventions

Digestive Enzyme Blend DIETARY_SUPPLEMENT

Oral

Digestive Enzyme Blend

Placebo DIETARY_SUPPLEMENT

Oral

Placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy adults who are 18 to 60 years of age (inclusive).
• In good general health (no underlying diseases or conditions) as deemed by the investigator.
• Have a body mass index (BMI) between 18.5 to 29.9 kg/m2 (inclusive).
• Weigh no less than 60 kilograms at screening and baseline.
• Self-reported presence of GI symptoms after consuming a high-fat meal.
• Are able to orally consume a porcine-based product in a form of capsule.
• Are able to consume a high-macronutrient meal within 20 minutes in-clinic, consisting of the following items:
• x BOOST® Protein+ Chocolate Meal Replacement Shake (325 mL)
• x McDonald's Sausage N'Egg McMuffin®
• x 3.25% Whole Milk (\~250 mL)
• x McDonald's Hash Brown
• x McDonald's Hotcakes with Butter (no syrup)
• Are able to consume a high-macronutrient meal at home each day as per the requirements:
• Supplement participants' meals to ensure the macronutrient targets are met with a supply of CLIF Builders Chocolate Peanut Butter Flavour Protein Bars (\~1 per day) prior to the at-home period.
• Consume the high-macronutrient at-home meal within the hours of 11:00 am to 7:00 pm daily.

You may not qualify if:

• Individuals who are lactating, pregnant or planning to become pregnant during the study, or demonstrate a positive pregnancy test at Visit 2.
• Have a known sensitivity, intolerability, or allergy to any of the study products or their excipients, or any of the ingredients in the high-macronutrient meal (in-clinic and at home).
• Currently following, or plan to follow a restrictive diet during the study, including low-fat, ketogenic or any other diet that significantly alters macronutrient intake.
• Have Type I diabetes, Type II diabetes, high blood pressure (≥140 systolic or ≥90 diastolic mmHg), or thyroid disease.
• Have a diagnosis of hypercholesterolemia or hypertriglyceridemia.
• Have a history of liver or gallbladder disease or stomach ulcers.
• Have a history of irritable bowel syndrome (IBS), inflammatory bowel disease (IBD, including ulcerative colitis), functional constipation or diarrhea (defined by the Rome IV diagnostic criteria), functional dyspepsia, celiac disease, malabsorption, gastroparesis, diverticulosis, gastric or duodenal ulcers, or eating disorder; or have a history of intestinal surgery (excluding appendectomy or herniorrhaphy) or bariatric surgery.
• Have blood or bleeding disorders (e.g. anemia).
• Have medical condition(s) known to interfere with absorption, distribution, metabolism, or excretion of the study product (e.g., Crohn's disease, short bowel, acute or chronic pancreatitis, or pancreatic insufficiency).
• Have a history of heart/cardiovascular disease, renal disease (dialysis or renal failure), hepatic impairment/disease, immune disorders and/or immunocompromised (i.e., HIV/AIDS).
• Have a history of cancer (except localized skin cancer without metastases or in situ cervical cancer), unless recovery occurred more than 5 years before the screening visit.
• Are receiving treatments for or have been hospitalized in the last 12 months for psychiatric disorders (e.g., depression, bipolar disorder, schizophrenia, etc.).
• Reports a clinically significant illness during the 28 days before the first dose of study product.
• Major surgery in 3 months prior to screening or planned major surgery during the study.
• Have a history of alcohol or substance abuse in the 12 months prior to screening (including having been hospitalized for such in an in-patient or out-patient intervention program) or use that in the opinion of the investigator may be of a concern for the study.

Sponsors & Collaborators

• Pancap Pharma Inc.: lead
• Nutrasource Pharmaceutical and Nutraceutical Services, Inc.: collaborator

Study Sites (1)

Apex Trials

Guelph, Ontario - on, N1G 0B4, Canada

Location

Study Officials

• Toni Matoski

  Pancap Pharma Inc.

  STUDY DIRECTOR

• John Mikhail

  Pancap Pharma Inc.

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 22, 2025
• First Posted: April 29, 2025
• Study Start: July 11, 2025
• Primary Completion: February 11, 2026
• Study Completion: February 11, 2026
• Last Updated: May 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)