What You Need to Know to Participate
This document provides information to help you decide whether to join this research study. It is important you understand the responsibilities, risks and benefits of participating.
| Details | |
|---|---|
| Study Purpose | Evaluate effects of Nattokinase (Toku Flow) on heart health and cholesterol |
| Duration | 12 weeks |
| Tasks | Cholesterol test (Week 1 & 12), daily supplement, daily tracking |
| Cost & Level of Effort | $363 & less than 2 minutes per day |
| Possible Risks | GI issues, bleeding risk, allergic reactions, headaches, tech frustration |
| Possible Benefits | Insight into Toku Flow's impact on personal cholesterol levels and contribution to broader research |
| Who Should Not Join | Individuals with soy allergy, on blood thinners, or with liver issues |
| Key Outcome Measures | LDL-C, HDL-C, Total Cholesterol, Non-HDL-C, Participant-reported adherence |
| Support Contact | help@efforia.com |
👍 The table above provides a summary. You may sign now and continue, or read more detail below.
1. Introduction and Summary
You are invited to participate in the Flow to a Healthier Heart Study, hosted on the Efforia platform. This 12-week observational wellness study investigates the effects of a natural supplement (Toku Flow, containing Nattokinase, derived from natto, a traditional Japanese food) on heart health.
Participation is voluntary. You may withdraw at any time without penalty or loss of benefits.
Your purchase funds all study materials and services. Efforia is a participant-supported research platform.
We encourage you to discuss participation with your healthcare provider before joining.
2. Purpose of the Study
This study aims to evaluate the impact of daily Nattokinase supplementation on cardiovascular markers, including cholesterol. Findings will contribute to a broader understanding of natural heart health interventions.
3. Study Procedures
If you choose to participate, you will be asked to:
- Complete a cholesterol test at home in Week 1 using the provided Tasso collection kit
- Take one dose of Toku Flow daily for 12 weeks, tracking your intake via the Efforia app
- Complete a second cholesterol test in Week 12
To ensure accuracy, complete tests early in the week (Monday–Wednesday). Daily adherence is key to generating meaningful results.
4. Risks and Discomforts
Participation may involve the following risks:
Physical: Gastrointestinal discomfort, dizziness, allergic reaction (especially to soy), increased bleeding risk
Psychological: Frustration with technology, discomfort from self-tracking, disappointment with results
Privacy: Minimal risk of data breach; see Privacy section below
Certain groups should avoid or carefully consider participation:
| Group | Risk |
|---|---|
| Taking anticoagulants | Increased bleeding risk |
| Soy allergies | Potential allergic reaction |
| Liver conditions | Possible liver enzyme elevation |
| GI disorders | Exacerbation of symptoms |
| Mood disorders | Potential mood/sleep impact |
| Professional athletes | Supplement compliance issues |
| Technologically sensitive individuals | Stress or irritation with platform |
Participants should consult a healthcare provider before joining.
5. Potential Benefits
- Personal: Insight into your cholesterol and potential supplement effects
- Societal: Contributions to citizen science and future heart health research
No guaranteed benefit is promised. Results may show no effect or adverse trends.
6. Study-Related Injuries and Compensation
Seek emergency care immediately for any urgent medical issues (call 911).
Efforia does not offer financial compensation or medical treatment for study-related injuries.
Report any adverse effects to help@efforia.com to aid in safety monitoring.
7. Alternatives
Participation is not required. If this study isn’t a good fit, Efforia offers a range of free and low-cost protocols. Click the Efforia logo at the top of the study page to browse options.
8. Confidentiality and Data Use
Efforia protects your data using encrypted storage and secure practices.
- Your name and identifying information will not be shared without consent
- Data may be shared with research partners (e.g., labs, device providers) under confidentiality agreements
- De-identified data may be used for aggregate analysis and research publication
Review our full Privacy Policy: https://efforia.com/privacy-policy
9. Your Rights as a Participant
You may withdraw at any time by clicking “Leave” on your protocol dashboard.
You have a right to:
- Access your personal results
- Ask questions at any time
- Confidentiality and data protection
- Be free from coercion or penalty for leaving
Refunds for unused products will be handled per our return policy.
10. Conflict of Interest
Efforia collects a transaction fee on bundled study services but does not sponsor or influence study outcomes.
You must not be employed by, invest in, or be affiliated with Efforia or its supplement providers.
Undisclosed conflicts of interest may result in termination from the platform without refund.
11. Data Protection and Your Role
You can enhance your privacy by:
- Securing your device and email with a password
- Controlling your communication preferences in the Efforia app
- Avoiding sharing account credentials
12. Questions or Concerns
For questions, adverse event reporting, or technical help:
- Efforia Support: help@efforia.com | (646) 679-2479
- Chat Support: Available within the platform
If you have concerns you’d rather not address with Efforia staff or would like to speak with someone about your rights as a participant, please contact an independent ethics reviewer. You may request a contact through Efforia at: ethics@efforia.com.
Consent Statement
By clicking “Join Study,” you confirm that you:
- Have read and understood this consent form
- Are at least 18 years of age
- Voluntarily agree to participate
- Understand that you may withdraw at any time