60 Day

Daily Digestive Health Enhancement with Masszymes

STUDY TITLE Daily Digestive Health Enhancement with Masszymes
Submitted under umbrella

Umbrella Protocol for Efforia Personalized Agentic Hypothesis Discovery & Experiential Proof Trials

Date submitted

—

End date

There is no pre-specified end date and sub-studies remain open long-term.

Language

English

Efforia AI IRB approval recommendation

—

Recruitment page preview

Preview

Informed consent

Review

Study author

Matthew Amsden

Principal investigator

Matthew Amsden

Sub-Investigator for Adverse Events

Dr. Viral Patel

Description

This protocol involves taking Masszymes with meals to enhance digestion and nutrient absorption. The focus is on incorporating Masszymes into daily routines to improve digestive comfort and support energy levels. Participants will be encouraged to share their digestive health transformation journey on social media.

Participant engagement length

60 Days

Sponsor

This study is made possible by your payment to cover all supplies and expenses required to participate.

Cost to participant

$99

Included products & services
Masszymes: $35
Outcome measures

PROMIS Scale v1.1 – Gastrointestinal Gas and Bloating 13a

PROMIS® Scale v1.0 – Gastrointestinal Belly Pain 5a Survey

PROMIS® Scale v1.0 – Gastrointestinal Constipation 9a

PROMIS® Scale v1.0 – Gastrointestinal Bowel Incontinence 4a Survey

Methodology

Single Arm longitudinal where participants act as their own control

Basic or advanced dissemination plan

Basic

Deviation from recruitment approach

No

Deviation from statistical approach

No

Will study include “more about you questions”

No

ClinicalTrials.gov

Yes

Commitment to list findings on ClinicalTrials.gov

Yes

This document is prepared with the assistance of AI, but is reviewed by a human.

Rational & Study Design

Why I created this study:

Digestive distress is more than just an inconvenience; it can impact every aspect of your life. From scholarly articles to social media buzz, there's a shared belief that enzymes like Masszymes can revolutionize gut health. However, the science needs a definitive nod. This study aims to quantify the impact of Masszymes on digestive comfort, using validated scales, to finally bring clarity to the enzyme debate. It's time to take the guesswork out of gut health.

My Objective for You:

Imagine a world where your digestive system feels like a well-oiled machine. My goal is to guide you there by integrating Masszymes into your daily routine. You'll track changes in digestive comfort, using PROMIS scales, to see real, tangible improvements. This isn't just about feeling better; it's about understanding your body's response, so you can make informed decisions about your health journey and share your triumphs with others.

Aims & Objectives:

This study aims to evaluate the impact of Masszymes on digestive health and nutrient absorption, focusing on reducing gastrointestinal discomfort and enhancing overall well-being. Participants will receive personalized insights into how Masszymes affect their digestive processes, empowering them to make informed decisions about their dietary habits and future wellness investments.

Significance & Impact:

By objectively measuring the effects of Masszymes on digestive health, this study could redefine how adults approach their wellness routines. Expected outcomes include improved digestive comfort and energy levels, but results may vary. The study's findings will not only contribute to academic understanding but also provide participants with actionable data, making it a potential game-changer in the realm of personal health optimization.

The Intervention

Included Products & Services

Product Name: Masszymes

Quantity included: 83

Price: $35.00

Product Description: MassZymes by BIOptimizers is a vegan digestive enzyme supplement designed to help break down proteins, fats, carbohydrates, fibers, and sugars. Its protease-forward formula supports everyday digestion, nutrient absorption, and post-meal comfort. It is intended for digestive support only and is not a treatment for any disease.

Product Image: Masszymes

Ingredients: Serving size: 3 capsules
Servings per container: 40 for the 120-capsule label reviewed. Bottle size may vary, but serving amounts should be verified against the physical label before use in a study.

Active enzyme blends

Protease / Peptidase Blend — 213.9 mg
Daily Value not established.

Protease, neutral/alkaline — 172,000 HUT
Protease, Bacillus subtilis — 143,000 HUT
Peptidase — 7,000 HUT

Enzyme Blend — 357.6 mg
Daily Value not established.

Fungal Amylase — 10,000 DU
Bromelain — 1,800,000 FCCPU
Alpha Galactosidase, Aspergillus niger — 475 GalU
Glucoamylase — 32 AGU
Lactase — 3,162 ALU
Fungal Lipase — 4,236 FIP
Lipase, yeast — 306 FIP
Lipase, food grade — 61.2 FIP
Lipase — 153 FIP
Invertase — 1,392 SU
Phytase, native yeast — 32 U
Pectinase — 19 ENDO-PG
Hemicellulase — 948 HCU
Cellulase — 632 CU
Beta Glucanase — 12 BG

Other ingredients: rice flour, hypromellose capsule, organic rice fib

Product Safety: MassZymes is a dietary supplement composed primarily of digestive enzymes. For healthy adults, digestive enzyme products are generally expected to be low risk when used as directed. The most plausible adverse effects are gastrointestinal: stomach upset, abdominal discomfort, nausea, gas, bloating, loose stools, or diarrhea. NCCIH notes that oral bromelain is generally well tolerated, with stomach upset and diarrhea among the most commonly reported side effects.

This product should not be represented as diagnosing, treating, curing, or preventing any disease. FDA states that dietary supplements are not approved for safety and effectiveness before sale, and that products intended to treat, prevent, cure, or alleviate disease are regulated as drugs even if labeled as supplements.

People who should not use MassZymes, unless specifically cleared by a clinician
Pregnant or breastfeeding individuals. BIOptimizers states that MassZymes is not recommended for pregnant or breastfeeding women, and NCCIH notes that little is known about bromelain safety during pregnancy or lactation.
People with active gastritis, gastric ulcer, or peptic ulcer disease. The product page states that digestive enzymes may not be a good idea in people with gastritis or ulcers.
People taking anticoagulants or antiplatelet drugs, including warfarin, apixaban, rivaroxaban, dabigatran, clopidogrel, aspirin, or high-dose NSAID use, unless cleared by a clinician. MSKCC specifically flags proteolytic enzymes/bromelain as a concern with anticoagulants because of possible bleeding risk, though clinical relevance is not fully established.
People with bleeding disorders, planned surgery, dental surgery, or recent major injury, unless cleared by a clinician. This is a precaution based mainly on the bromelain/proteolytic enzyme component and the possible effect on clotting.
People with known allergy or hypersensitivity to pineapple, bromelain, fungal enzymes, yeast-derived ingredients, rice, or any listed ingredient. Allergic reactions are uncommon but possible; discontinue immediately for hives, swelling, wheezing, throat tightness, or other signs of hypersensitivity.
Children or adolescents, unless under parent/guardian supervision and clinician approval. The company gives child dosing language on its site, but for research purposes this should not be assumed safe without a pediatric-specific protocol and review.
People with galactosemia should avoid using lactase-containing products to intentionally digest lactose-containing dairy unless medically supervised, because lactase breaks lactose into glucose and galactose.
Use with medical conditions: caution / clinician review recommended

Use should be reviewed with a healthcare professional for anyone with serious GI disease, inflammatory bowel disease flares, pancreatitis, liver disease, kidney disease, immune compromise, active cancer treatment, major chronic illness, or unexplained abdominal pain. MSKCC notes proteolytic enzymes have not been shown to prevent or treat cancer and reports gastrointestinal disturbance as a known side effect.

Medication interaction considerations

The most important medication concern is blood thinning or bleeding risk because the formula contains bromelain and other proteolytic enzymes. The manufacturer also advises consulting a healthcare professional before use, especially for people using medications, and notes that some enzymes may interact with blood-thinning medications.

Additional caution is reasonable with antibiotics or sedatives because bromelain is sometimes discussed as having interaction potential, but the most defensible study exclusion is anticoagulant/antiplatelet therapy unless cleared by a clinician.

Expected adverse events to monitor

For a study or participant-facing safety plan, monitor for:

Nausea, abdominal pain, heartburn, reflux, gas, bloating, diarrhea, or unusual stool changes
Mouth/throat irritation if capsule contents are opened
Allergic symptoms: rash, itching, hives, wheezing, swelling, throat tightness
Unusual bruising, nosebleeds, bleeding gums, black/tarry stools, or prolonged bleeding
Worsening ulcer-like symptoms: burning stomach pain, vomiting blood, severe abdominal pain

Participants should stop use and seek medical advice for significant GI pain, allergic symptoms, unusual bleeding/bruising, or any serious or unexpected adverse event. FDA also advises stopping a supplement and seeking medical advice if an adverse event occurs.

Study exclusion language

Exclude unless medically cleared: pregnancy, breastfeeding, active gastritis or ulcer disease, known allergy to pineapple/bromelain/fungal enzymes/yeast/rice, anticoagulant or antiplatelet medication use, bleeding disorder, planned surgery within 2 weeks, active major GI disease flare, severe chronic illness judged by investigator to increase risk, and minors unless the study is specifically designed and approved for pediatric participation.

Risk level: likely minimal risk for generally healthy adults using the product as directed, with the main foreseeable risks being mild-to-moderate GI symptoms, allergic reaction, and theoretical or possible bleeding interaction in susceptible participants.

Study Design & Methodology

Inappropriate Participants & Inclusion/Exclusion

Study Design & Experience

Statistical Analysis Plan

Limitations & Justification

Human Subjects Ethics

Suitability Under Minimal Risk Umbrella Protocol

Suitability for Pay to Participate Model

Human Subjects Protection Questionnaire