Clinical trial NCT06949735: Clinical Trial on Digestive Enzymes: Effects on Post-Meal Response to High-Fat, High-Protein Meals
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-fat and High-protein Meal
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Gastrointestinal Digestion
Healthy
Gastrointestinal Wellbeing
Gastrointestinal Supplements
Keywords: High-fat meal
High-protein meal
Digestive enzyme
Gastrointestinal
Digestion
Lead sponsor: Pancap Pharma Inc.
Sponsor class: INDUSTRY
Collaborators: name: Nutrasource Pharmaceutical and Nutraceutical Services, Inc.
First posted: 2025-04-29
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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-fat, high-protein 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-fat and high protein meal.

Detailed description: This study explores the potential benefits of digestive enzyme supplementation for individuals consuming high-fat, high-protein 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-fat and high-protein 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-fat, high-protein diets.

Eligibility criteria: Inclusion Criteria:

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.

Are able to orally consume a porcine-based product in a form of capsule.

Are able to consume a HFHP meal within 15 minutes in-clinic, consisting of:

1x BOOST® Protein + Chocolate Meal Replacement Shake (325mL)

1x 200mL Juice box of Apple Juice

1x McDonald's Sausage N' Egg McMuffin®

1x McDonald's Hash Brown

Are able to consume a HFHP meal at home each day consisting of:

Approximately 1 cup of homogenized 3.25% cow's milk (\~ 250mL) and 2x CLIF Builders Chocolate Peanut Butter Flavor Protein Bars

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.

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 HFHP 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.

Exclusion Criteria:

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 HFHP 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 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.

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.

Primary outcomes:
measure: To Assess the effect of the TP on lipid digestion after a single dose using area under the curve (AUC0-t) - Total Triglycerides
timeFrame: 30,60,90,120,180,210,240,270,300,330 and 360 minutes
Secondary outcomes:
measure: To assess the effect of the TP on lipid digestion after a single dose using maximum concentration (Cmax): Total Triglycerides
timeFrame: 30,60,90,120,180,210,240,270,300,330 and 360 minutes
measure: To assess the effect of the TP on lipid digestion after a single dose using time to reach maximum concentration (Tmax) - Total Triglycerides
timeFrame: 30,60,90,120,180,210,240,270,300,330 and 360 minutes
measure: 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)
timeFrame: 15,30,45,60,75,90,105,120,150,180,210,240,270,300,330,360 min.
measure: To assess the effect of the TP on protein digestion after a single dose using maximum concentration (Cmax):Total Free Amino Acids(TFAA)
timeFrame: 15,30,45,60,75,90,105,120,150,180,210,240,270,300,330,360 min.
measure: 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)
timeFrame: 15,30,45,60,75,90,105,120,150,180,210,240,270,300,330,360 min.
measure: To assess the effect of the TP on carbohydrate digestion after a single dose using area under the curve (AUC0-t): Glucose
timeFrame: 15,30,45,60,75,90,105,120,150,180,210,240,270,300,330,360 min.
measure: To assess the effect of the TP on carbohydrate digestion after a single dose using maximum concentration (Cmax): Glucose
timeFrame: 15,30,45,60,75,90,105,120,150,180,210,240,270,300,330,360 min.
measure: To assess the effect of the TP on carbohydrate digestion after a single dose using time to reach maximum concentration (Tmax): Glucose
timeFrame: 15,30,45,60,75,90,105,120,150,180,210,240,270,300,330,360 min.
measure: To assess the effect of the TP on carbohydrate digestion after a single dose using area under the curve (AUC0-t): Insulin
timeFrame: 15,30,45,60,75,90,105,120,150,180,210,240,270,300,330,360 min.
measure: To assess the effect of the TP on carbohydrate digestion after a single dose using maximum concentration (Cmax): Insulin
timeFrame: 15,30,45,60,75,90,105,120,150,180,210,240,270,300,330,360 min.
measure: To assess the effect of the TP on carbohydrate digestion after a single dose using time to reach maximum concentration (Tmax): Insulin
timeFrame: 15,30,45,60,75,90,105,120,150,180,210,240,270,300,330,360 min.
measure: To assess the effect of TP on appetite after a single dose using VAS score - Pre dose and Pre Meal
timeFrame: 30,90,120,180,240,300 and 360 min.
measure: To assess the effect of TP on gastrointestinal (GI) symptoms after a single dose using VAS score - Pre -Dose and Pre Meal
timeFrame: 30,90,120,180, and 360 min.
measure: To assess the effect of TP on abdominal distention after a single dose in waist Circumference - Pre -Dose and Pre Meal
timeFrame: 30,90,120,180, and 360 min.
measure: 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
timeFrame: 7 days
Other outcomes:
measure: To assess the safety of the TP
timeFrame: 7 weeks
Locations:
city: Guelph
country: Canada
facility: Apex Trials
state: Ontario - ON
Study officials:
affiliation: Pancap Pharma Inc.
name: Toni Matoski
role: STUDY_DIRECTOR
affiliation: Pancap Pharma Inc.
name: John Mikhail
role: STUDY_CHAIR
References: