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Gastrointestinal DigestionPhase 2NCT06949735

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

A Phase 2 study testing Digestive Enzyme Blend in people with Gastrointestinal Digestion and Healthy, run by Pancap Pharma Inc. at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 60 yearsHealthy volunteers can take part
What is being tested?
Digestive Enzyme Blend
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
24 participants
Where
1 siteCanada
Study dates
11 Jul 2025to 11 Feb 2026
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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.
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  • Are able to consume a high-macronutrient meal within 20 minutes in-clinic, consisting of the following items:
  • 1 x BOOST® Protein+ Chocolate Meal Replacement Shake (325 mL)
  • 1 x McDonald's Sausage N'Egg McMuffin®
  • 1 x 3.25% Whole Milk (~250 mL)
  • 2 x McDonald's Hash Brown
  • 1 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.
  • At-home meals must be purchased from commonly available fast food restaurants (e.g., McDonald's, Harvey's, Burger King) that provide publicly accessible nutrition information.
  • Non-smokers (including nicotine vaping) and have not used any nicotine products (patches, gums, etc.) for > 3 months prior to Visit 2.
  • Non-smoker is defined as someone who does not habitually/regularly use products containing nicotine.
  • Have a glycated hemoglobin (HbA1c) below 5.7% as assessed at screening.
  • Agree not to donate blood during the study and within 90 days after completing the study.
  • Have suitable veins for repeated venipuncture.
  • Have maintained consistent dietary habits, including medication and supplement intake, and lifestyle for the last 3 months before screening and agree to maintain them throughout the study (with the exception of the high-macronutrient meals).
  • Agree to follow the restrictions on concomitant treatments
  • Agree to follow the restrictions on lifestyle
  • Agree to use acceptable contraceptive methods
  • Willing and able to agree to the requirements of this study, be willing to give voluntary consent, be able to understand and read the questionnaires, and carry out all study-related procedures.

Who cannot join

  • 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.
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  • 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.
  • Significant blood loss or blood donation totaling between 101 mL to 449 mL of blood within 30 days prior to first dose of study product or a blood donation of more than 450 mL within 90 days prior to first dose of study product.
  • Donation of plasma (e.g., plasmapheresis) within 15 days prior to first dose of study product.
  • Current enrollment or past participation in another study with any product(s) with at least one active ingredient within 28 days before first dose of study product or longer, if the previous test product is deemed by the investigator to have lasting effects that might influence the eligibility criteria or outcomes of current study.
  • Living in the same household as another currently/previously enrolled participant in the present study.
  • Any other medical condition/situation or use of medications/supplements/therapies that, in the opinion of the investigator, may adversely affect the participant's ability to participate in the study or its measures or pose a significant risk to the participant.

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • Apex Trials

    Guelph, Ontario - on, N1G 0B4

Other trials in Canada

About this study

Official title: A Randomized, Double-blind, Placebo-controlled, Crossover Clinical Trial to Investigate the Effect of Digestive Enzyme Supplementation on Postprandial Responses to a High-macronutrient Meal

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.

Read the detailed description

This study explores the potential benefits of digestive enzyme supplementation for individuals consuming high-macronutrient meals. Digestive enzymes play an important role in breaking down macronutrients to facilitate nutrient absorption. While the body naturally produces these enzymes, certain factors such as genetic predisposition, aging, or high dietary intake of fats and proteins can strain the digestive system, leading to incomplete digestion and gastrointestinal discomfort.

High-macronutrient meals require significant enzymatic activity for proper breakdown, and inadequate digestion can result in symptoms like bloating, indigestion, and changes in gut microbiota. Undigested fats and proteins in the colon can contribute to digestive discomfort, while improperly broken-down carbohydrates may lead to increased gas production and microbial imbalances. These effects can impact overall digestive efficiency, nutrient availability, and gut health.

This clinical trial investigates the efficacy of a delayed-release, porcine-derived enzyme blend containing 20,000 lipase units in improving digestion and gastrointestinal well-being. The study follows a randomized, placebo-controlled, crossover design to assess how this enzyme supplement affects macronutrient breakdown and post-meal symptoms. Researchers will evaluate both immediate effects after a single dose and longer-term benefits after seven days of supplementation, including its impact on quality of life. The findings may provide insight into whether digestive enzyme supplementation can enhance nutrient absorption and alleviate digestive discomfort in individuals consuming high-macronutrient diets.

Being tested
Digestive Enzyme Blend, Placebo
Keywords
Digestive enzyme, Gastrointestinal, Digestion, High-macronutrient meal

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Digestive Enzyme BlendDietary supplement

    Oral

  • PlaceboDietary supplement

    Oral

Study groups in NCT06949735
Study groupRoleWhat they receive
Digestive Enzyme BlendActive comparatorActive ingredients: Porcine Pancreatic Enzyme
Receives: Dietary Supplement: Digestive Enzyme Blend
PlaceboPlacebo comparatorActive ingredients: None
Receives: Dietary Supplement: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

Secondary outcomes (15)

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

    Comparison of total triglycerides up to 360 min in response to the high-macronutrient meal.

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

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

    Comparison of total triglycerides up to 360 min in response to the High-macronutrient meal.

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

  3. 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)

    Comparison of total leucine up to 360 min in response to the High-macronutrient meal.

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

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

    Comparison of total free amino acids up to 360 min in response to the High-macronutrient meal.

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

  5. 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)

    Comparison of total free amino acids up to 360 min in response to the High-macronutrient meal.

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

  6. To assess the effect of the TP on carbohydrate digestion after a single dose using area under the curve (AUC0-t): Glucose

    Comparison of glucose up to 360 min in response to the high-macronutrient meal.

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

  7. To assess the effect of the TP on carbohydrate digestion after a single dose using maximum concentration (Cmax): Glucose

    Comparison of glucose up to 360 min in response to the high-macronutrient meal.

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

  8. To assess the effect of the TP on carbohydrate digestion after a single dose using time to reach maximum concentration (Tmax): Glucose

    Comparison of glucose up to 360 min in response to the high-macronutrient meal.

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

  9. To assess the effect of the TP on carbohydrate digestion after a single dose using area under the curve (AUC0-t): Insulin

    Comparison of insulin up to 360 min in response to the high-macronutrient meal.

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

  10. To assess the effect of the TP on carbohydrate digestion after a single dose using maximum concentration (Cmax): Insulin

    Comparison of insulin up to 360 min in response to the high-macronutrient meal.

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

  11. To assess the effect of the TP on carbohydrate digestion after a single dose using time to reach maximum concentration (Tmax): Insulin

    Comparison of insulin up to 360 min in response to the high-macronutrient meal.

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

  12. To assess the effect of TP on appetite after a single dose using VAS score - Pre dose and Pre Meal

    Change from pre-dose 30,90,120,180,240 and 360 min after the start of high-macronutrient meal.

    Measured: 30,90,120,180,240,300 and 360 minutes

  13. To assess the effect of TP on gastrointestinal (GI) symptoms after a single dose using VAS score - Pre -Dose and Pre Meal

    Change from pre-dose 30,90,120,180, and 360 min after the start of high-macronutrient meal.

    Measured: 30,90,120,180, and 360 minutes

  14. To assess the effect of TP on abdominal distention after a single dose in waist Circumference - Pre -Dose and Pre Meal

    Change from pre-dose 30,90,120,180, and 360 min after the start of high-macronutrient meal.

    Measured: 30,90,120,180, and 360 minutes

  15. To assess the effect of the TP on GI-related quality of life after 7 days of supplementation assessed by the PROMIS Scale V1.1 GI Gas and Bloating

    Change from baseline to 7 days in severity rating of GI symptoms.

    Measured: 7 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Apr 2025
  2. Study start11 Jul 2025
  3. Primary completion11 Feb 2026
  4. Study completion11 Feb 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
24 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06949735
Sponsor's protocol ID
P02-24-01-T0074
Status last verified
Apr 2026
First submitted
22 Apr 2025
Last updated
1 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Digestive Enzyme Blend in people with Gastrointestinal Digestion and Healthy, run by Pancap Pharma Inc. at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 26 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To Assess the effect of the TP on lipid digestion after a single dose using area under the curve (AUC0-t) - Total Triglycerides (time frame: 30,60,90,120,180,210,240,270,300,330 and 360 minutes). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06949735.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2026.

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