Ignite Creation Date:
2025-12-24 @ 10:35 PM
Ignite Modification Date:
2026-01-01 @ 6:17 PM
Study NCT ID:
NCT06949735
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-07-25
First Post:
2025-04-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Trial on Digestive Enzymes: Effects on Post-Meal Response to High-Fat, High-Protein Meals
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 24}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2025-07-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2025-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-21', 'studyFirstSubmitDate': '2025-04-22', 'studyFirstSubmitQcDate': '2025-04-22', 'lastUpdatePostDateStruct': {'date': '2025-07-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-04-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'To assess the safety of the TP', 'timeFrame': '7 weeks', 'description': 'Report of Adverse Events (AEs)'}], 'primaryOutcomes': [{'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', 'description': 'Comparison of total Triglycerides (TG) up to 360 min in response to the high-fat and high-protein (HFHP) meal.'}], 'secondaryOutcomes': [{'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', 'description': 'Comparison of total triglycerides up to 360 min in response to the high-fat and high-protein (HFHP) meal.'}, {'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', 'description': 'Comparison of total triglycerides up to 360 min in response to the High-fat and high-protein (HFHP) meal.'}, {'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.', 'description': 'Comparison of total leucine up to 360 min in response to the High-fat and high-protein (HFHP) meal.'}, {'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.', 'description': 'Comparison of total free amino acids up to 360 min in response to the High-fat and high-protein (HFHP) meal.'}, {'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.', 'description': 'Comparison of total free amino acids up to 360 min in response to the High-fat and high-protein (HFHP) meal.'}, {'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.', 'description': 'Comparison of glucose up to 360 min in response to the high-fat and high-protein (HFHP) meal.'}, {'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.', 'description': 'Comparison of glucose up to 360 min in response to the high-fat and high-protein (HFHP) meal.'}, {'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.', 'description': 'Comparison of glucose up to 360 min in response to the high-fat and high-protein (HFHP) meal.'}, {'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.', 'description': 'Comparison of insulin up to 360 min in response to the high-fat and high-protein (HFHP) meal.'}, {'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.', 'description': 'Comparison of insulin up to 360 min in response to the high-fat and high-protein (HFHP) meal.'}, {'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.', 'description': 'Comparison of insulin up to 360 min in response to the high-fat and high-protein (HFHP) meal.'}, {'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.', 'description': 'Change from pre-dose 30,90,120,180,240 and 360 min after the start of high-fat and high protein (HFHP) meal.'}, {'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.', 'description': 'Change from pre-dose 30,90,120,180, and 360 min after the start of high-fat and high protein (HFHP) meal.'}, {'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.', 'description': 'Change from pre-dose 30,90,120,180, and 360 min after the start of high-fat and high protein (HFHP) meal.'}, {'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', 'description': 'Change from baseline to 7 days in severity rating of GI symptoms.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['High-fat meal', 'High-protein meal', 'Digestive enzyme', 'Gastrointestinal', 'Digestion'], 'conditions': ['Gastrointestinal Digestion', 'Healthy', 'Gastrointestinal Wellbeing', 'Gastrointestinal Supplements']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nHigh-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.\n\nThis 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\nHealthy adults who are 18 to 60 years of age (inclusive).\n\nIn good general health (no underlying diseases or conditions) as deemed by the investigator.\n\nHave a body mass index (BMI) between 18.5 to 29.9 kg/m2 (inclusive).\n\nWeigh no less than 60 kilograms at screening and baseline.\n\nAre able to orally consume a porcine-based product in a form of capsule.\n\nAre able to consume a HFHP meal within 15 minutes in-clinic, consisting of:\n\n1x BOOST® Protein + Chocolate Meal Replacement Shake (325mL)\n\n1x 200mL Juice box of Apple Juice\n\n1x McDonald's Sausage N' Egg McMuffin®\n\n1x McDonald's Hash Brown\n\nAre able to consume a HFHP meal at home each day consisting of:\n\nApproximately 1 cup of homogenized 3.25% cow's milk (\\~ 250mL) and 2x CLIF Builders Chocolate Peanut Butter Flavor Protein Bars\n\nNon-smokers (including nicotine vaping) and have not used any nicotine products (patches, gums, etc.) for \\> 3 months prior to Visit 2.\n\nNon-smoker is defined as someone who does not habitually/regularly use products containing nicotine.\n\nHave a glycated hemoglobin (HbA1c) below 5.7% as assessed at screening.\n\nHave suitable veins for repeated venipuncture.\n\nHave 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)\n\nAgree to follow the restrictions on concomitant treatments\n\nAgree to follow the restrictions on lifestyle\n\nAgree to use acceptable contraceptive methods\n\nWilling 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.\n\nExclusion Criteria:\n\nIndividuals who are lactating, pregnant or planning to become pregnant during the study, or demonstrate a positive pregnancy test at Visit 2.\n\nHave 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).\n\nCurrently following, or plan to follow a restrictive diet during the study, including low-fat, ketogenic or any other diet that significantly alters macronutrient intake.\n\nHave Type I diabetes, Type II diabetes, high blood pressure (≥140 systolic or ≥90 diastolic mmHg), or thyroid disease.\n\nHave a diagnosis of hypercholesterolemia or hypertriglyceridemia. Have a history of liver or gallbladder disease or stomach ulcers.\n\nHave 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.\n\nHave blood or bleeding disorders (e.g. anemia).\n\nHave 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).\n\nHave a history of heart/cardiovascular disease, renal disease (dialysis or renal failure), hepatic impairment/disease, immune disorders and/or immunocompromised (i.e., HIV/AIDS).\n\nHave 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.\n\nAre receiving treatments for or have been hospitalized in the last 12 months for psychiatric disorders (e.g., depression, bipolar disorder, schizophrenia, etc.).\n\nReports a clinically significant illness during the 28 days before the first dose of study product.\n\nMajor surgery in 3 months prior to screening or planned major surgery during the study.\n\nHave 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.\n\nSignificant 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.\n\nDonation of plasma (e.g., plasmapheresis) within 15 days prior to first dose of study product.\n\nCurrent 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.\n\nLiving in the same household as another currently/previously enrolled participant in the present study.\n\nAny 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."}, 'identificationModule': {'nctId': 'NCT06949735', 'briefTitle': 'Clinical Trial on Digestive Enzymes: Effects on Post-Meal Response to High-Fat, High-Protein Meals', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pancap Pharma Inc.'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'P02-24-01-T0074'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Digestive Enzyme Blend', 'description': 'Active ingredients: Porcine Pancreatic Enzyme', 'interventionNames': ['Dietary Supplement: Digestive Enzyme Blend']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Active ingredients: None', 'interventionNames': ['Dietary Supplement: Placebo']}], 'interventions': [{'name': 'Digestive Enzyme Blend', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Oral', 'armGroupLabels': ['Digestive Enzyme Blend']}, {'name': 'Placebo', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Oral', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'N1G 0B4', 'city': 'Guelph', 'state': 'Ontario - on', 'country': 'Canada', 'facility': 'Apex Trials', 'geoPoint': {'lat': 43.54594, 'lon': -80.25599}}], 'overallOfficials': [{'name': 'Toni Matoski', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pancap Pharma Inc.'}, {'name': 'John Mikhail', 'role': 'STUDY_CHAIR', 'affiliation': 'Pancap Pharma Inc.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pancap Pharma Inc.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Nutrasource Pharmaceutical and Nutraceutical Services, Inc.', 'class': 'NETWORK'}], 'responsibleParty': {'type': 'SPONSOR'}}}}