Important Information
You are invited to participate in MassZymes by BIOptimizers: Can Enzymes Improve Digestion? on the Efforia platform. This consent form explains the study, what you will be asked to do, the study design, reasonably foreseeable risks and potential benefits, costs, product ingredients, privacy protections, injury and compensation information, and your rights.
This is a voluntary, minimal-risk citizen-science research study. You may choose not to join or may leave at any time without penalty. This study is not medical care, and MassZymes is not intended to diagnose, treat, cure, or prevent disease.
Study design: This is an open-label, prospective, single-arm, within-participant before-and-after study. There is no placebo group, randomization, blinding, or external control group. Your results during treatment will be compared with your own results during the baseline period. Because there is no placebo or external control group, the study can identify changes over time but cannot establish definitive causal efficacy.
| Key Information | |
|---|---|
| Study Title | MassZymes by BIOptimizers: Can Enzymes Improve Digestion? |
| Purpose | To learn whether 14 days of MassZymes use is associated with changes in gas and bloating, belly pain, constipation symptoms, fatigue, sleep disturbance, and post-exercise muscle soreness in generally healthy adults with occasional digestive discomfort. |
| Study Design | Open-label, prospective, single-arm, within-participant before-and-after study. There is no placebo or external control group. |
| Study Length | 28 days total: a 14-day baseline period followed by a 14-day MassZymes treatment period. |
| Assessment Schedule | Baseline assessments occur on participant Days 1, 7, and 14. Treatment follow-up assessments occur on Treatment Days 7 and 14. The final Treatment Day 14 assessment may be completed within a window of 3 days before or 3 days after the target day. |
| What You Will Do | Complete baseline questionnaires; then take 3 MassZymes capsules once daily with your largest meal for 14 days; record each dose; and complete follow-up questionnaires and safety check-ins. |
| Your Cost | The nominal study cost is $35, covering the MassZymes product and study-related materials and supplies. A default 100% subsidy coupon will be applied so participation is provided at no cost for up to 150 participants. You will not be paid for participating. |
| Main Risks | Digestive upset or changes in bowel habits, nausea, cramping, allergic or sensitivity reaction, difficulty swallowing a capsule, possible interactions with medications or other supplements, vitamin D exposure, survey burden, and loss of confidentiality. Some risks may be unknown. |
| Potential Benefits | You may or may not notice improved digestion or related well-being. Benefits are not guaranteed. |
What will I be asked to do?
If you join, you will complete a 14-day baseline period before starting MassZymes. Complete the baseline assessments on Days 1, 7, and 14. During the following 14-day treatment period, take 3 MassZymes capsules once daily with your largest meal, record each dose, complete assigned questionnaires, and complete safety check-ins. Treatment follow-up assessments are scheduled for Treatment Days 7 and 14. The final Treatment Day 14 assessment may be completed within 3 days before or 3 days after the target day. When possible, avoid beginning other new health regimens during the study because they may affect interpretation of your results.
What is the study design?
This is an open-label, single-arm, before-and-after study. You will know that you are taking MassZymes. There is no placebo, randomization, blinding, or external control group. Your treatment-period responses will be compared with your own baseline responses. The results are exploratory and cannot prove that MassZymes caused any change.
What is in MassZymes?
Each 3-capsule serving contains vitamin D3 (as cholecalciferol), 60 mcg (300% Daily Value); a Protease/Peptidase Blend, 213.9 mg, including neutral/alkaline protease 172,000 HUT, Bacillus subtilis protease 143,000 HUT, and peptidase 7,000 HUT; and an Enzyme Blend, 357.6 mg, including fungal amylase 10,000 DU, bromelain 1,800,000 FCCPU, alpha-galactosidase from Aspergillus niger 475 GalU, glucoamylase 32 AGU, lactase 3,162 ALU, fungal lipase 4,236 FIP, yeast lipase 306 FIP, food-grade lipase 61.2 FIP, lipase 153 FIP, invertase 1,392 SU, phytase from native yeast 32 U, pectinase 19 ENDO-PG, hemicellulase 948 HCU, cellulase 632 CU, and beta-glucanase 12 BG.
Other ingredients are rice flour, hypromellose (capsule), and organic rice fiber. The product is described as plant-based/vegan, dairy-free, soy-free, and gluten-free. It contains pineapple-derived bromelain and microbial or fungal enzyme sources. Do not participate if you have a known allergy or sensitivity to MassZymes, any listed ingredient, pineapple, rice ingredients, capsule materials, or related enzyme sources.
What are the risks and discomforts?
Possible risks include digestive symptoms such as nausea, stomach discomfort, cramping, gas, bloating, diarrhea, or constipation; allergic or sensitivity reactions; medication or supplement interactions; difficulty swallowing capsules; exposure to vitamin D; survey burden; privacy risk; and unknown risks. Stop taking the product and seek urgent medical care for trouble breathing, facial or throat swelling, fainting, severe or persistent abdominal pain, blood in vomit or stool, or another medical emergency.
Who should not join, or should speak with a clinician first?
This study does not use a separate traditional eligibility-screening questionnaire. Adults who can provide informed consent review the study information and decide for themselves whether participation and product use are appropriate. This is consent-based self-assessment and safety guidance, not a medical diagnosis, medical clearance, or formal eligibility determination.
Do not join if you are under 18; cannot provide informed consent; are pregnant, trying to become pregnant, or breastfeeding; have a known allergy or serious sensitivity to any product ingredient or enzyme source; have significant or unstable gastrointestinal disease or another unstable medical condition; or have been advised by a clinician not to participate. Speak with a qualified healthcare professional before joining if you take prescription medicines or supplements, particularly blood thinners or products that affect bleeding; have a bleeding disorder; have surgery planned; have a history of severe allergic reactions; have chronic liver or kidney disease; have difficulty swallowing capsules; have concerns about vitamin D intake; or are undergoing evaluation for unexplained or worsening digestive symptoms.
What are the possible benefits?
You may experience improvement in digestive or related wellness symptoms, but no personal benefit is promised. Your de-identified data may contribute to generalizable knowledge about digestive-enzyme use.
Will I be paid? What will participation cost?
The nominal study cost is $35. A default 100% subsidy coupon will be applied, so participation is provided at no cost for up to 150 participants. You will not receive compensation for your time.
What if I am injured or need medical care?
If you believe you have been injured or become ill because of the study product or study procedures, stop the product if appropriate, seek medical care, and contact the study team at help@efforia.com. The study does not provide payment for participation, lost time, or research-related injury, and Efforia does not routinely pay medical expenses you choose to obtain. Nothing in this statement limits any rights or remedies that cannot legally be waived.
Is participation voluntary, and can I leave?
Your participation is voluntary. You may stop the product or leave the study at any time and for any reason. Information already collected may still be retained and used as permitted by this consent and applicable law.
Questions, concerns, or complaints
For questions about study tasks, the product, side effects, withdrawal, or technical support, contact help@efforia.com. For questions about your rights as a research participant, contact ethics@efforia.com.
Consent statement
By accepting this consent, you confirm that you have read and understood the information above, including the study design, schedule, product ingredients and safety information, and injury/compensation information; that you are voluntarily choosing to participate; and that you may withdraw at any time.