Enzyme pill takes on Post-Meal bloating in new trial

NCT ID NCT06949735

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a digestive enzyme supplement in 24 healthy adults to see if it helps break down fats, proteins, and carbs after a high-macronutrient meal. Participants took either the enzyme blend or a placebo and reported symptoms like bloating and gas. The goal is to find a simple supplement that eases digestive discomfort.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
digestive enzyme supplement (porcine-derived blend)
What this could lead to
If it works, this could point toward an over-the-counter supplement to ease bloating and discomfort after eating a heavy meal.
What could go wrong
This is a small, early-phase trial with only 24 healthy adults. The supplement may not work better than a placebo, and results may not apply to people with digestive disorders.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

24 people

The number who actually took part.

Started

Jul 2025

Finished

Feb 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 60 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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. 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: * 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. 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 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. 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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Apex Trials

    Guelph, Ontario - on, N1G 0B4, Canada

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Other studies related to the condition(s) this trial covers.