Summary Information to Help you Decide Whether to Join this Study

Study Title	Impact Study: Perfect Keto Collagen+MCT on Self-Reported Recovery
Study Author	Justin Eaton
Sponsor	This study is made possible by your payment to join.
Cost of Products, Services & Information to Participant	$43
Included Products & Services	Grass-Fed Collagen Peptides & MCT Brain Boost (formerly Keto Collagen) – Vanilla
Outcome Measures	PROMIS Short Form v1.0 – Fatigue 8a, Athlete Psychological Strain Questionnaire, Athlete Sleep Screening Questionnaire (ASSQ), Hooper & MacKinnon Questionnaire (Hopper Index)
Contact	help@efforia.com

Introduction & Summary

Welcome to our research study on Efforia! This study is made possible by your participation and financial contribution. We aim to understand how Perfect Keto Collagen and MCT Powder can impact self-reported recovery. Your participation is voluntary, and you can leave at any time without penalty. If you have questions, please seek answers before proceeding.

Efforia is a citizen science platform where studies are effectively sponsored by, you, the participants. Unlike traditional research studies, you pay for all the supplies, services, information, and tools needed for participation in one transaction. This makes studies possible that might not be otherwise.

Although you could buy these products and services separately for a similar cost, Efforia bundles them into one purchase for convenience. Efforia organizes these items and provides instructions to create a comprehensive, data-driven research experience. This setup allows you to track and understand the impact on your own life via detailed outcome reports, making informed personal health decisions easier. It also advances broader research findings, benefiting others who might not afford such purchases without guaranteed results.

Efforia is committed to equitable inclusion. If the cost is too high for you, click the large Efforia logo at the top of the screen to explore other protocols. Efforia offers protocols on various topics at different price points, including free options, so you can find one that suits your goals and budget.

Purpose of the Study

This study aims to evaluate the effects of Perfect Keto Collagen and MCT Powder on recovery speed and fatigue reduction over 30 days. By participating, you contribute to scientific knowledge on these supplements and help others who may benefit from this research. We use measures like the PROMIS Short Form v1.0 – Fatigue 8a and the Athlete Psychological Strain Questionnaire to assess outcomes.

What You Will Do as Part of this Study

While participating in this research study, you will need to:

• Be willing and able to follow the study directions and procedures
• Tell Efforia about any side effects or problems by communicating with help@efforia.com or online chat.
• Ask questions as you think of them, via help@efforia.com or online chat.
• Inform Efforia if you change your mind about staying in the study. You may leave the study at any time by communicating with help@efforia.com or chat.

Participants in this study are tasked with evaluating the effects of Perfect Keto Collagen and MCT Powder on recovery speed and fatigue reduction over a period of 30 days. The study involves completing the PROMIS Short Form v1.0 – Fatigue 8a and Athlete Psychological Strain Questionnaire across an 8-week timeline to monitor progress. Baseline measurements will be taken using the Athlete Sleep Screening Questionnaire (ASSQ) and Hooper & MacKinnon Questionnaire (Hopper Index) before starting the daily supplement regimen.

Participants must adhere to a personalized protocol schedule, which includes a reminder and instructions for post-workout consumption of the supplements. Regular check-ins via the Safety Check-In form are mandatory to ensure participants' well-being throughout the study. The PROMIS Short Form, Athlete Sleep Screening, and Athlete Psychological Strain Questionnaire measurements will be conducted periodically, requiring participants to provide data at designated intervals.

Adherence to the timeline is crucial for the validity of the study, as consistent participation ensures accurate data collection and a reliable evaluation of the supplements' impact on athletic performance. Participants are encouraged to integrate their schedule with Google Calendar and Todoist to stay organized and maintain communication with the study organizers.

The Risks, Discomforts & Benefits of Being in this Study

There are some unique risks, discomforts, and potential benefits of being in this study that you should understand.

Consider your Own Risk-Benefit Comfort Level

It is possible that not all risks and benefits are currently known. Participants have the responsibility to consult with their healthcare providers and conduct further research before enrolling in the study.

Personal and Overall Findings

Efforia will provide you with both personal outcomes as well as overall findings. These findings will be made available at various data collection points in your experience in the study or as they are discovered by Efforia. The results and findings may impact your interest and willingness to be involved in the study. Remember, participation is voluntary and you may exit at any time with an e-mail to help@efforia.com.

Possible Benefits of Participation

Participating in this study may offer insights into the effectiveness of Perfect Keto Collagen and MCT Powder on your recovery and fatigue levels. You will have access to detailed reports and data-driven conclusions that may help you make informed decisions about your health and wellness. However, there is a possibility that there will be no measurable benefit to you, other than seeing reports that the intervention or treatment had no measurable impact.

Possible Serious Adverse Events & Side Effects

Risk Assessment for Grass-Fed Collagen Peptides & MCT Brain Boost (Vanilla)

Introduction and Summary of Known Risks

The product under evaluation, Grass-Fed Collagen Peptides & MCT Brain Boost, is designed to support muscle recovery and reduce fatigue in athletes through daily supplementation. Despite potential benefits, it is essential to consider potential risks and side effects associated with its ingredients, collagen and medium-chain triglycerides (MCT). The maximum dosages tested in available studies often vary, but adverse effects have been noted with excessive intake, particularly exceeding 10 grams of collagen or significant amounts of MCT oil which can lead to gastrointestinal distress.

The following is a summary of known risks. However, research is limited, and there may be risks not covered by this document, risks that are currently unknown or unforeseen. Please consider these risks carefully, do your own research, and talk to a professional who knows you well and has expertise in this area, like your personal physician.

In the Case of an Adverse Event

If you experience any severe or life-threatening symptoms, immediately call 911 or visit the nearest emergency room. After the acute situation has been managed, please inform the study coordinators at Efforia about the event so appropriate measures can be taken to ensure your safety and adjust the study protocol if necessary.

Serious Adverse Events (SAEs)

While the occurrence of Serious Adverse Events due to supplementation with collagen and MCT is relatively low, potential risks cannot be ignored. These include severe allergic reactions, gastrointestinal blockages, and metabolic disturbances.

Theoretical Side Effects	Relative Incidence	Recovery
Gastrointestinal Symptoms (nausea, diarrhea)	Moderate Likelihood	Subsides with discontinuation
Skin & Hair Reactions (rashes, acne)	Low Likelihood	Subsides after discontinuation
Mood Changes	Low Likelihood	Subsides after discontinuation
Cognitive impairment, intoxication	Very Low Likelihood	Subsides with use
Frustration and irritation	Moderate Likelihood	May persist during study

Certain Individuals May be At Increased Risk

Here is a table identifying individuals who should avoid participating in this trial based on the provided risks, intervention, and outcome measures: Individuals who fall into these categories are advised to consult healthcare professionals familiar with their health history to determine if participation is appropriate based on personal health conditions and potential risks involved.

Category of Individual	Contraindications	Reason
Individuals with Gastrointestinal Disorders	High sensitivity to collagen or MCT intake	May experience exacerbated gastrointestinal distress, such as nausea or diarrhea
Individuals with Tree Nut Allergies	Known allergies to MCT derived from tree nuts	Risk of severe allergic reactions due to possible exposure in supplements
Pregnant Individuals	Pregnancy, or planning to become pregnant	Potential risks to fetal development and lack of sufficient safety data during pregnancy
Individuals with Metabolic Disorders	Susceptibility to metabolic disturbances	Potential risk of exacerbated metabolic imbalances with MCT supplementation
Individuals with Skin Conditions	History of skin reactions or sensitivities	Risk of skin reactions such as rashes or acne
Individuals Concerned About Mood Changes	Susceptibility to mood swings or psychological issues	Low likelihood but potential mood changes or psychological dependence on supplements
Individuals with Cognitive Impairments	Cognitive vulnerabilities or history of intoxication	Though very low likelihood, potential for cognitive impairment or intoxication

 

 

Efforia's Limitations in Providing Direct Medical Support

Efforia is not equipped to provide immediate medical intervention. Participants are advised to rely on local healthcare facilities for emergencies and inform Efforia post-event.

Long-term Dependence

Long-term dependence on this supplement is unlikely due to its nature and the short duration of typical usage. However, psychological dependence on supplements for performance enhancement is possible.

Legality and Compliance

The ingredients in Grass-Fed Collagen Peptides & MCT Brain Boost are generally recognized as safe and compliant with the World Anti-Doping Association (WADA) and National Collegiate Athletic Association (NCAA) standards. However, athletes are advised to consult their governing bodies as regulations may change.

This document provides a comprehensive overview of potential risks associated with Grass-Fed Collagen Peptides & MCT Brain Boost. Remaining informed and vigilant about symptom development is crucial for safety during supplementation in athletic or any performance-based activities.

Privacy & Security Risks

We are doing everything we can think of to keep your data private and confidential. However, there is no such thing as no risk. Potential participants should review the Efforia general privacy policy, which is available here: https://efforia.com/privacy-policy/

There may be very certain limits to the rights of your privacy:

• We may reach out to local help if we have reason to believe you may be a harm to yourself and/or others.
• Regulators, like the FDA or similar agency, or Institutional Review boards may review records that have your identifying information.

What to do if you have a study related injury

In the event of an injury, seek local medical care first if necessary. Efforia cannot provide emergency medical care or diagnosis. However, it is important to contact Efforia if you experience any problems, side effects, or study-related injury after receiving necessary treatment. We want to make sure others are aware of potential risks.

Study related injury care and compensation

Efforia is not able to offer financial compensation nor to absorb the costs of medical treatment should you be injured as a result of participating in this research. Efforia makes no commitment to provide free medical care or payment for any unfavorable outcomes resulting from participation in this research.

In the case of medical emergency

In the case of a medical emergency please dial 911 immediately. Do not attempt to contact Efforia until after the emergency has passed. Access local in person medical assistance immediately.
If at any time you feel like you may be a danger to yourself or others, please dial 988 for the National Suicide Prevention hotline. Help is available.

Alternatives to Participating in the Study

Since this study is for research only, the only other choice would be not to be in the study. If this study does not seem quite right or is too expensive for your specific purposes, Efforia is dedicated to making other studies available. You may click on the Efforia logo in the upper portion of the page and find a different study that may be more appropriate.

Your Rights as a Participant:

Efforia upholds the same high ethical standards in research as seen in pharmaceutical and academic studies, despite only hosting and not sponsoring or conducting these studies. Your participation in this study is completely voluntary, and you are free to withdraw at any time without any adverse consequences. You are not giving up any rights by signing this document.

Privacy and Confidentiality:

You have a right to privacy and confidentiality in this research effort. Your personal information is protected through robust measures ensuring anonymity or confidentiality. All data processing is designed to safeguard personal data against unauthorized access and misuse.

Right to Your Own Results:

Participants have the right to a complete explanation of the research once their involvement concludes, particularly if the study involves any form of deception like placebos or controls.

The Right to Leave a Study without Penalty at Any time

If you decide to withdraw from the study, you can do so at any time by visiting your Profile page, selecting "Your Protocols," and clicking "Leave." Upon leaving, you will be refunded for any consumable products that have not yet been shipped. For non-consumable products, a full refund will be issued upon their return in accordance with our return policy. This ensures that you can participate in the study with the assurance that your financial contributions are handled fairly and with respect for your consumer rights.

Conflict of Interest Statement

As part of our commitment to ethical conduct and transparency in our citizen science clinical trial, it is essential to disclose the unique structure of our study. This clinical trial is hosted by Efforia, but it is uniquely sponsored by you, the participants. Efforia serves solely as the platform provider and does not sponsor or influence the study outcomes.

Efforia takes a transaction fee on all the products and services included in this protocol. Otherwise, we have no financial interest or conflicts of interest. To further reduce conflicts of interest, we will remind you once if you do not complete enrollment in this study. We will not remarket to you, nor otherwise push you to join the study.

How we Reduce Conflicts of Interest:

It is crucial that participants do not have any financial relationship with the intervention methods or measurement providers used in the trial, nor should they be employees, investors, stakeholders, or protocol authors associated with these entities. Participation under such conflicts of interest could significantly compromise the study's integrity and the validity of its results.

Consequences of Conflict of Interest Non-Compliance:

Should a participant fail to disclose such a conflict of interest or if a breach of this policy is discovered, the participant will be subject to immediate suspension from this platform and payments may not be refunded. By joining this trial, you affirm that you understand the above conflict of interest restrictions and agree to comply fully with them. Your participation is valued, and your adherence to these guidelines ensures the validity and reliability of our collective scientific efforts.

Data Protections:

Efforia will collect, use, and protect your data in compliance with data protection laws. We ensure that your information is secure and handled responsibly.

What you can do to improve your privacy and security:

As part of participating in this study, you will receive notifications via e-mail, SMS, or push notification when new study tasks like questionnaires and reminders are ready for you. You can adjust your communication preferences in the Efforia application at any time. If you do not want to receive notifications from this study, do not press the Accept button. You can decide not to join this study, and will not receive notifications. To ensure others don’t see these alerts, you should make sure your phone or desktop computer and your e-mail accounts are protected by a password, pin, or other form of “access control.” You should also avoid sharing your accounts with others or sharing your account passwords. As this study is hosted in Efforia, it is governed by a set of privacy and confidentiality standards that put you, as a participant, in control. You can learn more about Your Privacy and Security rights on Efforia here: https://efforia.com/privacy-policy/.

Who will have access to your data?

Efforia will have access to your data. There may also be partners who have access to your data, such as labs and connected health devices.

What will we do with your data

We will use the data to show you your own personal results and pool your results with other participants to provide general outcomes. We will not use your information connected with your name or anything that connects the data with you without your permission.

California Experiential Research Subject’s Bill of Rights:

Participants are entitled to the California Experiential Research Subject Bill of Rights. For further details, refer to the Efforia privacy policy: https://efforia.com/privacy-policy/.

Who to Contact for Questions or Concerns

If you have questions, concerns, or complaints about this study or to report a study-related injury, contact:

• HELP@EFFORIA.COM
• (646) 679-2479
• OR CLICK THE CHAT BUTTON ON YOUR SCREEN

If you are unable to reach anyone at the number(s) listed above and you require immediate (life-threatening) medical attention, please go to the nearest emergency room.

If you do not want to talk to the investigator or study staff, if you have concerns or complaints about the research, or to ask questions about your rights as a study subject you may contact Univo IRB. Univo IRB is an independent committee that helps to protect the rights and welfare of research participants. If you have any questions about your rights and welfare as a research participant, or have concerns or complaints regarding this research study, please contact Univo IRB at (919) 910-7743 or via email at info@univo-group.com.

Univo IRB
4509 Creedmoor Road
Suite 403
Raleigh, NC 27612
info@univo-group.com
(919) 910-7743

Additional questions and closing

Efforia and Univo have approved the information in this consent form and have given approval to publish this study. This does not mean Efforia or Univo have approved your being in the study. You must consider the information in this consent form for yourself and decide if you want to be in this study. If you have questions, please contact help@efforia.com. It is up to you to do additional research and talk to your physician before joining a study.