Trials Sponsors Conditions Drugs Pricing

Conditions

Gastrointestinal Digestion Gastrointestinal Supplements Gastrointestinal Wellbeing Healthy

Keywords

Digestive enzymeGastrointestinalDigestionHigh-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

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 BlendDietary supplement

Oral

Digestive Enzyme Blend

PlaceboDietary supplement

Oral

Placebo

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years - 60 Years

Sexall

Healthy VolunteersYes

Age GroupsAdult (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.

Sponsors & Collaborators

Pancap Pharma Inc.
Industrylead
Nutrasource Pharmaceutical and Nutraceutical Services, Inc.
Research networkcollaborator

Study Sites (1)

Apex Trials

Guelph, Ontario - on, N1G 0B4, Canada

Study Officials

Toni Matoski
Pancap Pharma Inc.
STUDY DIRECTOR
John Mikhail
Pancap Pharma Inc.
STUDY CHAIR

Enrollment

24 participants (actual enrollment reported by the registry).

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

Actual (reported)

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.
+5 more criteria

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (15)

Study Arms (2)

Digestive Enzyme Blend

Placebo

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Study Officials

Enrollment

Study Design

Study Record Dates

Other Outcomes (1)

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (15)

Study Arms (2)

Digestive Enzyme Blend

Placebo

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Study Officials

Enrollment

Study Design

Study Record Dates

Other Outcomes (1)

You may not qualify if:

Data Sharing

Source record

Locations