90 Day

Impact of Daily Creatine Supplementation on Cognitive Functions

STUDY TITLE Impact of Daily Creatine Supplementation on Cognitive Functions
Submitted under umbrella

Minimal Risk Citizen Science Umbrella Protocol

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

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Informed consent

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Study author

Gregory Hung, Matthew Amsden

Principal investigator

Matthew Amsden

Sub-Investigator for Adverse Events

Dr. Viral Patel

Description

This protocol explores the effect of daily Test Product Creatine supplementation on cognitive functions over a period of 2-3 months. Participants will be guided on how to take the Test Product Creatine supplement every morning and will be encouraged to observe any changes in their mental sharpness, memory, and overall cognitive performance throughout the duration of the study.

Participant engagement length

90 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
Test Product Creatine: $0
Outcome measures

Quality of Life and Health Survey

36-Item Short Form Survey Instrument (SF-36)

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”

Yes

Recruitment jurisdictions

United States, United Kingdom

Clinicaltrials.Gov

Yes

Committment 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 challenge:

Scientific literature has suggested a potential role of creatine in enhancing cognitive functions. Nonetheless, there is widespread social media chatter claiming creatine solely as a bodybuilding supplement. This dichotomy between academic findings and popular belief made me curious. As a fitness enthusiast and cognitive performance advocate, I felt compelled to design this challenge. It's vital to run this study to validate or debunk the claim that daily creatine supplementation can boost cognitive functions.

My Objective for You:

My goal for each participant is to explore whether daily consumption of Test Product Creatine can effectively enhance cognitive functions. This is not just about proving a scientific hypothesis; it's about potentially uncovering a simple, affordable strategy to improve mental acuity, memory, and overall cognitive health.

Aims & Objectives:

This study aims to evaluate the impact of daily creatine supplementation on cognitive performance. The objective is to determine whether there's a significant change in the Quality of Life and Health Survey and 36-Item Short Form Survey Instrument (SF-36) scores from baseline to the 93rd day.

Significance & Impact:

If successful, this challenge could shift the perception of creatine from merely a bodybuilding supplement to a cognitive enhancer, impacting millions of individuals seeking cognitive improvements. However, it's essential to acknowledge that individual results may vary, and the challenge doesn't substitute professional medical advice.

The Intervention

Scientific evidence suggests that creatine supplementation may enhance cognitive functions, supported by some clinical trials showing improved memory and mental performance. While the medical community is cautiously optimistic, emphasizing the need for more extensive studies, social media buzz often limits creatine's benefits to muscle building. The general population is divided, with some recognizing its cognitive potential and others skeptical of its broader benefits. Risks are minimal, typically limited to mild digestive issues, while potential benefits could be significant for cognitive health.

Included Products & Services

Product Name: Test Product Creatine

Quantity included: 30

Price: $0.00

Product Description: Description

Product Image:

Ingredients:

Product Safety:

Study Design & Methodology

Inappropriate Participants & Inclusion/Exclusion

Without specific details on the risks, informed consent, and intervention, I'll provide a general template that can be adapted with the appropriate details once they are available.

Category of Individual Contraindications Reason
Pregnant or breastfeeding women Pregnancy and lactation Potential unknown risks to the fetus or infant; lack of safety data
Individuals with severe allergies Known severe allergies to components Risk of severe allergic reactions such as anaphylaxis
People with compromised immune systems Immunocompromised conditions Increased susceptibility to infections or adverse reactions
Patients with chronic illnesses Unstable or severe chronic illnesses Potential for worsening of the underlying condition or complications
Children and adolescents Age under the age of consent Ethical concerns and different risk profiles in this population
Individuals on multiple medications Polypharmacy Possible drug interactions leading to adverse effects
People with a history of mental health disorders Severe mental health issues Risk of exacerbation of mental health symptoms or poor compliance
Elderly individuals Advanced age with frailty Increased risk of adverse events and slower recovery times
Individuals with liver or kidney impairment Hepatic or renal impairment Altered metabolism and excretion of the intervention leading to toxicity

This table can be modified and filled out with specific details about the risks, informed consent, intervention, and outcome measures for the study in question.

Study Design & Experience

Treatment activities:

Daily Activity: Consume Test Product Creatine as part of your daily routine.

Assesments and frequency:
  • Initial Phase: Complete the Quality of Life and Health Survey and the 36-Item Short Form Survey Instrument (SF-36).
  • Ongoing: Repeat the Quality of Life and Health Survey and the 36-Item Short Form Survey Instrument (SF-36) periodically throughout the 90-day challenge.
Methodology:

Impact of Daily Creatine Supplementation on Cognitive Functions

The "Impact of Daily Creatine Supplementation on Cognitive Functions" study aims to investigate the potential cognitive benefits of daily creatine supplementation over a period of 2-3 months. This single-arm observational trial will utilize participants as their own controls to minimize variability and enhance the reliability of the results. Participants will be instructed to take the Test Product Creatine supplement every morning and will be encouraged to monitor and record any changes in their mental sharpness, memory, and overall cognitive functioning throughout the study duration. For more detailed information, please refer to the "Minimal Risk Umbrella protocol."

The study is designed as a "Signal Phase" investigation at Efforia, which means it seeks to provide a directional indication of potential positive effects of creatine on cognitive functions. By deploying a single-arm design, the research will preliminarily assess if there is a notable improvement in cognitive performance metrics among participants. This phase will also collect essential safety data that is currently lacking. The primary endpoints include changes in mental sharpness, memory retention, and overall cognitive acuity, assessed through validated instruments such as the Quality of Life and Health Survey, and the 36-Item Short Form Survey Instrument (SF-36).

Participants will engage in a structured study experience, which will include several activities and assessments. They will begin by understanding the protocol, guided by Gregory Hung over the 90-day period. Participants will complete initial and follow-up surveys to measure their quality of life and cognitive health. Daily supplementation with creatine will be rigorously monitored to ensure adherence and collect data on any cognitive changes. Should the study indicate a positive signal—suggesting that creatine supplementation enhances cognitive functions—more robust study designs will be considered for future research to further validate these findings.

Expected sample size:

Power Analysis and Sample Size Calculation

Assumptions:

  1. Effect Size (Cohen's d): 0.1
  2. Significance Level (α): Primary at 0.05, robustness check at 0.10
  3. Power (1 - β): 0.80
  4. Dropout Rate: 60%
  5. Statistical Methods: Paired t-tests for within-group comparisons; ANOVA for between-group comparisons.

Sample Size Calculations:

  1. Minimum Sample Size: No Stratification

    • Method: Paired t-test
    • Effect Size (Cohen's d): 0.1
    • Significance Level (α): 0.05
    • Power (1 - β): 0.80

    Using a power analysis calculator for a paired t-test:

    [ n = \frac{2(Z_{\alpha/2} + Z_{\beta})^2}{\text{Effect Size}^2} ]

    Where:

    • ( Z_{\alpha/2} ) is the critical value for significance level (α = 0.05) which is 1.96.
    • ( Z_{\beta} ) is the critical value for power (1 - β = 0.80) which is 0.84.

    [ n = \frac{2(1.96 + 0.84)^2}{0.1^2} = \frac{2(2.8)^2}{0.01} = \frac{2 \times 7.84}{0.01} = \frac{15.68}{0.01} = 1568 ]

    Adjusting for a 60% dropout rate:

    [ n_{\text{adjusted}} = \frac{1568}{1 - 0.60} = \frac{1568}{0.40} = 3920 ]

    Minimum Sample Size: 3920 participants

  2. Middle Sample Size: Stratified by Treatment Expectancy

    • Stratification by treatment expectancy (high vs. low)
    • Assume equal distribution between high and low expectancy groups

    For each group (high and low expectancy):

    [ n_{\text{group}} = \frac{1568}{2} = 784 ]

    Adjusting for dropout rate in each group:

    [ n_{\text{group, adjusted}} = \frac{784}{0.40} = 1960 ]

    Middle Sample Size: (1960 \times 2 = 3920)

    Since the dropout rate is already accounted for in the individual groups, the overall sample size remains the same.

  3. Maximum Sample Size: Stratified by Various Health and Fitness Measures

    • Stratification by multiple factors (e.g., sex, physical activity levels, self-reported disease states, self-reported overall health, stress levels, self-reported obesity rates)
    • Assume 6 stratification factors with 2 levels each (e.g., male/female, high/low physical activity, etc.)

    Total number of subgroups = (2^6 = 64)

    Sample size per subgroup:

    [ n_{\text{subgroup}} = \frac{1568}{64} = 24.5 \approx 25 ]

    Adjusting for dropout rate:

    [ n_{\text{subgroup, adjusted}} = \frac{25}{0.40} = 62.5 \approx 63 ]

    Maximum Sample Size: (63 \times 64 = 4032)

Justification:

  • Minimum Sample Size (3920): This calculation assumes no stratification and only accounts for the dropout rate, ensuring a sufficient number of participants to detect a small effect size with 80% power.

  • Middle Sample Size (3920): This stratification by treatment expectancy does not change the overall sample size due to the equal distribution between high and low expectancy groups, but ensures control for expectancy bias.

  • Maximum Sample Size (4032): Stratifying by multiple health and fitness measures increases the number of subgroups significantly. This comprehensive stratification ensures that the study can control for various potential confounders, providing more detailed insights into the effects of creatine supplementation on cognitive functions across different health and fitness profiles.

Robustness Check at α = 0.10:

If the significance level is relaxed to α = 0.10, the critical value ( Z_{\alpha/2} ) changes to 1.645. Recalculating for the minimum sample size:

[ n = \frac{2(1.645 + 0.84)^2}{0.1^2} = \frac{2(2.485)^2}{0.01} = \frac{2 \times 6.175}{0.01} = \frac{12.35}{0.01} = 1235 ]

Adjusting for dropout rate:

[ n_{\text{adjusted}} = \frac{1235}{0.40} = 3087.5 \approx 3088 ]

Thus, the new sample sizes would be:

  • Minimum Sample Size: 3088
  • Middle Sample Size: 3088 (assuming equal distribution)
  • Maximum Sample Size: (64 \times \frac{1235}{64}/0.40 \approx 3176)

Summary:

The sample sizes required for detecting a statistically significant effect under the given assumptions are:

  • Minimum: 3920 participants, no stratification.
  • Middle: 3920 participants, stratified by treatment expectancy.
  • Maximum: 4032 participants, stratified by multiple health and fitness measures.

Robustness check at α = 0.10 suggests slightly lower sample sizes:

  • Minimum: 3088 participants.
  • Middle: 3088 participants.
  • Maximum: 3176 participants.

Statistical Analysis Plan

Limitations & Justification

Limitations and Justifications

This single-arm observational trial, conducted under the Minimal Risk Citizen Science Umbrella Protocol, aims to evaluate the impact of daily creatine supplementation on cognitive performance. One key limitation of this study design is the absence of a control group, which inherently introduces bias and limits the ability to definitively attribute observed changes in cognitive performance to the intervention. To address this limitation, we are implementing an expectations questionnaire to quantify participant bias, providing a clearer understanding of how expectations may influence outcomes. This approach allows us to account for the placebo effect and other biases, although it does not entirely eliminate them.

Another potential limitation is the sample size and demographic diversity of the participants, which may affect the generalizability of the findings. To mitigate this, our statistical methodology includes stratification by participant demographics, ensuring that subgroup analyses can provide more nuanced insights into the impact of creatine supplementation across different segments of the population. This careful stratification enhances the interpretability of the data, making the findings more robust despite the single-arm design. Furthermore, the primary objective is to serve as a signal detection study. Should the results indicate a positive signal, subsequent studies with more rigorous controls and larger sample sizes will be conducted to replicate and validate the findings, ensuring that any potential benefits are thoroughly examined.

A core goal of Efforia and the Minimal Risk Umbrella Protocol is to democratize clinical research by supporting research questions and researchers that might otherwise be overlooked. This study is a prime example, addressing a gap between scientific literature and popular belief regarding creatine's role in cognitive enhancement. By allowing fitness enthusiasts and cognitive performance advocates to explore this potential benefit, the study promotes inclusivity and broadens the scope of clinical research. Participants are encouraged to refer to the Minimal Risk Umbrella Protocol for more comprehensive information, ensuring transparency and accessibility throughout the research process.

Human Subjects Ethics

Suitability Under Minimal Risk Umbrella Protocol

Based on the provided criteria for studies under the minimal risk umbrella protocol, the protocol titled "Impact of Daily Creatine Supplementation on Cognitive Functions" appears suitable for inclusion. This study fits within the parameters of minimal risk as defined by 45 CFR 46.102(i), as it involves an intervention (creatine supplementation) that is generally recognized as safe (GRAS). Creatine supplements are widely available and do not require a prescription or physician diagnosis in most jurisdictions. Additionally, the study focuses on enhancing general health and cognitive function, which falls under the broad "health and wellness" domain specified in the umbrella protocol.

Furthermore, the study does not involve vulnerable populations as defined by the Common Rule subparts B, C, and D (children, pregnant women, and incarcerated individuals). It does not require a physician's diagnosis or prescription, nor does it test interventions classified as medical devices or regulated pharmaceuticals. The protocol does not include any form of blinding, deception, or comparative study design and does not require more than two blood draws or other bodily fluid specimen collections. The intervention—creatine supplementation—does not fall under the category of interventions banned by sports regulatory bodies and is not subject to regulatory approval. Thus, the protocol aligns well with the minimal risk umbrella protocol's requirements and is deemed suitable for inclusion.

Suitability for Pay to Participate Model

In the study "Impact of Daily Creatine Supplementation on Cognitive Functions," it is appropriate to allow participants to pay for the Test Product Creatine for several key reasons. Firstly, creatine supplements are generally available for legal purchase on the open market in the United States and other countries where the protocol will operate. Individuals are typically willing to pay for creatine supplements as they are widely recognized for their potential benefits in both athletic performance and cognitive function. The price of $99 for a 2-3 month supply is comparable to or even less than what consumers might expect to pay for high-quality creatine supplements available in retail stores or online.

Furthermore, the study offers additional value beyond just the creatine supplement itself. Participants will receive guided instructions on how to take the supplement, which enhances the user experience by ensuring correct and effective usage. The study also provides a structured environment for monitoring cognitive improvements, which adds a layer of scientific evaluation that participants would not typically receive when purchasing creatine independently. Given that the typical target market for creatine supplements includes health-conscious individuals who can generally afford this price without serious financial hardship, and considering the lack of severe vulnerabilities in this population that would lead to significant buyer's remorse, the pay-to-participate model is both ethical and practical for this study.

Human Subjects Protection Questionnaire

Beneficence

  1. Is there a description, unambiguous research question, and purpose?

    • Yes. The study protocol includes a clear description of the research question and purpose, ensuring that the objectives are well-defined and comprehensible.
  2. Is the study built on what is known already?

    • Yes. The study builds on existing literature and knowledge, leveraging previous research to inform its design and methodology.
  3. Will the study provide meaningful answers to the research question?

    • Yes. The study is designed to generate meaningful data that will address the research question effectively, contributing valuable insights to the field.
  4. Will the study provide valid answers to the research question?

    • Yes. The study employs rigorous methodologies and controls to ensure the validity of its findings, thereby providing reliable answers to the research question.

Non-maleficence

  1. Are participants recruited with justifiable inclusion and exclusion criteria?

    • Yes. The inclusion and exclusion criteria are well-justified, ensuring that participants are appropriately selected to achieve the study's objectives while minimizing risk.
  2. Does the research team have the experience, skills, facilities, and time to complete the study?

    • Yes. The research team is highly qualified, with extensive infrastructure in place from the Efforia platform. The Principal Investigator, Matthew Amsden, has significant experience in decentralized trial innovation and management, and Dr. Viral Patel is available to support and confirm any adverse events. Detailed information is available in the Minimal Risk Umbrella Protocol.
  3. Is there a fair balance of benefits and harms (risks) for all with an interest in the study?

    • Yes. The study is designed to balance the benefits and risks fairly, considering the interests of all stakeholders and ensuring minimal risk to participants.
  4. Will participants receive appropriate care both during and after the study?

    • Yes. Participants are advised to seek their own medical care in case of an adverse event, as outlined in the informed consent. The minimal risk nature of the interventions, coupled with adverse event monitoring, ensures that participants receive more care than they would outside the study. Additional details are provided in the Minimal Risk Umbrella Protocol.
  5. Is personal data handled appropriately (confidentiality)?

    • Yes. Personal data is handled with strict confidentiality, as detailed in the Minimal Risk Umbrella Protocol.

Autonomy

  1. Have participants been offered a fair choice through the information they are given (presented in plain English) and consent process?

    • Yes. The informed consent document is clear and comprehensive, providing detailed information about the study, its risks, benefits, and the voluntary nature of participation, enabling participants to make an informed decision.
  2. Has the research incorporated patient and participant views?

    • Yes. Efforia’s design as a citizen science clinical trial platform inherently incorporates participant views. This study specifically includes participant feedback regarding their experiences with MoonBrew, and the consent document encourages ongoing input from participants.

Justice

  1. Are there fair payments for participation and financial recompense in case of harm?

    • Yes. While participants pay to participate, they receive a valuable product and health outcome tracking, providing intrinsic value. In case of adverse events, participants are instructed to seek medical care and report the incident to Efforia, with the understanding that medical care is their own financial responsibility.
  2. Do participants have access to an independent complaints procedure (or advocate)?

    • Yes. Participants can contact Efforia's support for any concerns or complaints. The informed consent document also includes contact information for an independent ethics review board, providing an additional avenue for addressing issues.
  3. Will the project be registered and results reported in the public domain?

    • Yes. Efforia is committed to transparency, making personal results available to participants immediately and ensuring that generalizable results are reported to build credibility.

Study Design and Experience

  1. Is the study design appropriate and does the team have relevant experience?
    • Yes. The study design is well-structured, leveraging the extensive infrastructure of the Efforia platform. The team, led by Matthew Amsden, possesses significant experience in decentralized trials, ensuring robust execution and management.

Inappropriate Participants and Exclusion/Inclusion

  1. Are the inclusion and exclusion criteria appropriate?
    • Yes. The criteria are carefully crafted to include appropriate participants while excluding those who may not benefit or could be at risk, ensuring the study's objectives are met without compromising participant safety.

Suitability for Pay to Participate Model

  1. Is the pay-to-participate model suitable for this study?
    • Yes. The model is suitable as it provides participants with a valuable product and health tracking services, justifying the cost. The study also ensures transparency and voluntary participation, aligning with ethical standards.

Suitability under Minimal Risk Umbrella Protocol

  1. Is the study suitable under the Minimal Risk Umbrella Protocol?
    • Yes. The study's minimal risk nature and robust oversight mechanisms align well with the Minimal Risk Umbrella Protocol, ensuring participant safety and data integrity.

Logging

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