30 Day
High Protein Diet Impact on Testosterone Levels
| STUDY TITLE | High Protein Diet Impact on Testosterone Levels |
|---|---|
| Submitted under umbrella | |
| Date submitted |
Aug 27, 2024 |
| 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 | |
| Author edit | |
| Informed consent | |
| Study author |
Reviewer1 User2 |
| Principal investigator |
Matthew Amsden |
| Sub-Investigator for Adverse Events |
Dr. Viral Patel |
| Description |
This intervention is centered around incorporating a high-protein diet to assess its impact on testosterone levels. This dietary shift will involve the increase of protein intake through a variety of protein-rich foods such as lean meats, poultry, fish, and plant-based proteins. The intervention does not involve any specific products or services for tracking or assisting the process, focusing solely on the dietary change. |
| Participant engagement length |
30 Days |
| Sponsor |
This study is made possible by your payment to cover all supplies and expenses required to participate. |
| Cost to participant |
$0 |
| Included products & services |
Tasso Blood Specimen Collection Kit – Old: $0
Withings Scale: $59
|
| Outcome measures |
Withings Weight Strava Data Blood Testosterone Test |
| 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 |
| Committment to list findings on clinicaltrials.Gov |
Yes |
Preview This document is prepared with the assistance of AI, but is reviewed by a human.
Rational & Study Design
Why I created this challenge:
As someone deeply immersed in fitness and nutrition, I've noticed the growing chatter about the role of protein in boosting testosterone levels. Academic research shows that adequate protein intake can support muscle growth and recovery, but its direct link to testosterone levels remains under-explored. On social media and in the popular press, many believe that a high-protein diet can naturally elevate testosterone. This challenge aims to bridge the gap between anecdotal claims and scientific evidence by rigorously measuring the impact of a high-protein diet on testosterone levels. It’s vital to run this study to provide clarity and actionable insights for anyone looking to optimize their hormone health through diet.
My Objective for You:
Our goal is to empower you with concrete evidence on how a high-protein diet can influence your testosterone levels. By participating, you'll gain personalized insights that can help you make informed dietary choices to optimize your fitness and overall well-being.
Aims & Objectives:
This study aims to assess the impact of a high-protein diet on testosterone levels in adult males. We seek to provide evidence-based recommendations for dietary adjustments to enhance hormonal health.
Significance & Impact:
This challenge could revolutionize how we understand the relationship between diet and hormone levels, particularly testosterone. Expected outcomes include a clearer understanding of how protein intake affects testosterone, better-informed dietary choices, and improved fitness results. However, individual variations and adherence to the diet may limit the generalizability of the findings.
The Intervention
Included Products & Services
Product Name: Tasso Blood Specimen Collection Kit – Old
Quantity included: 3
Price: $0.00
Product Description: The Tasso blood specimen collection kit allows users to collect their own blood samples at home without direct interaction with a lab or phlebotomist. The kit includes a Tasso button that sticks to the skin with an adhesive. When the button is pressed, a vacuum forms and a lancet pricks the skin to draw blood out of the capillaries and into a container attached to the bottom of the button. The user sets a five-minute timer to allow the device to collect the required amount of capillary blood. The user then removes and caps the blood-collection tube and sends it to the lab in prepaid packaging provided by Tasso. The tubes are designed to fit directly into standard blood-analysis machines, so results are fast.
Product Image:
Ingredients:
Product Safety:
Product Name: Withings Scale
Quantity included: 1
Price: $59.00
Product Description:
Product Image:
Ingredients:
Product Safety:
Study Design & Methodology
Inappropriate Participants & Inclusion/Exclusion
| Category of Individual | Contraindications | Reason |
|-------------------------|-------------------|--------|
| Individuals with Severe Allergies | Known severe allergic reactions to Tasso Kit materials | Risk of severe allergic reaction, including anaphylaxis |
| Individuals with Mobility Issues | Difficulty standing or balance issues | Increased risk of falls and injuries from using the Withings Scale |
| Individuals with Kidney Disease | Pre-existing kidney conditions | High-protein diets can exacerbate kidney strain |
| Pregnant or Nursing Women | Any potential unknown risks | Lack of specific research data on the safety of high-protein diets during pregnancy or lactation |
| Individuals with Nutrient Imbalances | Conditions like hypercalcemia or hypocalcemia | High-protein diets may exacerbate nutrient imbalances |
| Individuals with Blood Disorders | Conditions like hemophilia or anemia | Potential complications from blood sample collection with the Tasso Kit |
| Individuals with Eating Disorders | History of anorexia, bulimia, or other eating disorders | High-protein diet interventions may trigger or exacerbate eating disorder behaviors |
| Elderly Individuals | Age-related health issues | Increased risk of falls and injuries, as well as potential strain on kidneys from high-protein diets |
| Individuals on Anticoagulants | Use of blood thinners like warfarin | Increased risk of bleeding complications from blood sample collection |
This table identifies individuals who should avoid or seriously consider whether participation in this study is right for them based on potential risks and contraindications.
Study Design & Experience
Assesments and frequency:
Baseline: Complete the Baseline Weight Measurement and Baseline Dietary Intake Measure.
Day 30: Complete the Weight Measurement, Strava Data, Testosterone Levels, and Dietary Intake Measure.
Methodology: It looks like you started writing something but didn't finish. How can I assist you today? If you have a task list, questions, or need help with something specific, feel free to let me know!
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Work Tasks
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Statistical Analysis Plan
Limitations & Justification
Human Subjects Ethics
Suitability Under Minimal Risk Umbrella Protocol
Additionally, the protocol outlines a longitudinal study design, which involves monitoring participants over several days or weeks, adhering to the requirement for longer-term observation. The study does not involve more than two blood draws or the collection of other bodily fluids, thus meeting the minimal risk criteria. There is no indication that the study includes vulnerable populations, interventions requiring a physician’s diagnosis or prescription, or interventions that are regulated as medical devices or pharmaceuticals. Therefore, based on the preliminary review, this protocol is suitable for inclusion under the minimal risk umbrella protocol.
However, it is crucial to ensure that all other elements of the study, including recruitment, informed consent, and data collection procedures, strictly adhere to the guidelines and ethical standards established by Efforia and the relevant regulatory bodies.
Suitability for Pay to Participate Model
Moreover, the typical target market consumers of these products—those interested in health and fitness—can generally afford these costs without experiencing serious financial hardship. The study's design includes the purchase of products that these individuals might already be inclined to buy for personal use. This reduces the risk of severe and acute vulnerabilities or significant buyer’s remorse among participants. Given this context, allowing participants to pay for the Withings Scale and Tasso Blood Specimen Collection Kit aligns with the principles of respect for persons and autonomy, enhancing beneficence, and ensuring justice and equitable participation. The study offers participants tangible benefits that justify the associated costs, thereby maintaining ethical standards in human research protections.
Human Subjects Protection Questionnaire
### Study Design and Experience
To define your study design, consider the following elements:
1. **Objective and Hypothesis:**
- Clearly state the objective of your study. What are you trying to discover, prove, or understand?
- Formulate a hypothesis that is testable and measurable.
2. **Study Type:**
- Decide whether your study is experimental, observational, longitudinal, cross-sectional, etc.
- Choose between qualitative, quantitative, or mixed methods.
3. **Population and Sample:**
- Define your target population.
- Decide on your sampling method (random, stratified, convenience, etc.).
4. **Interventions and Variables:**
- Identify independent and dependent variables.
- Describe any interventions or treatments that will be administered.
5. **Data Collection Methods:**
- Determine how data will be collected (surveys, interviews, experiments, etc.).
- Ensure methods are valid and reliable.
6. **Data Analysis:**
- Plan your statistical or thematic analysis methods.
- Ensure you have the appropriate tools and expertise.
### Inappropriate Participants and Inclusion/Exclusion Criteria
Define clear criteria for who should and should not participate:
1. **Inclusion Criteria:**
- Age range, gender, health status, etc.
- Specific characteristics pertinent to the study (e.g., diagnosed with a particular condition).
2. **Exclusion Criteria:**
- Factors that would disqualify a participant (e.g., comorbid conditions, medications that could interfere with results).
- Ethical considerations (e.g., vulnerable populations).
### Suitability for Pay to Participate Model
Evaluate if participants should pay to be part of the study:
1. **Ethical Considerations:**
- Ensure the study adheres to ethical guidelines.
- Consider if paying to participate could introduce bias or exclude certain populations.
2. **Value Proposition:**
- Determine what participants gain from the study (e.g., access to new treatments, personal health insights).
3. **Regulatory Requirements:**
- Check with ethics review boards and regulatory bodies to ensure compliance.
### Suitability Under Minimal Risk Umbrella Protocol
Assess if the study fits under a minimal risk protocol:
1. **Risk Assessment:**
- Evaluate potential risks to participants (physical, psychological, social, etc.).
- Ensure risks are minimal, akin to daily life or routine medical exams.
2. **Risk Mitigation:**
- Outline steps to minimize and manage risks.
- Include monitoring and support systems for participants.
3. **Ethical Approval:**
- Obtain approval from an Institutional Review Board (IRB) or Ethics Committee.
- Provide clear information to participants about risks and benefits.
By addressing these points, you can create a well-rounded study design that is ethical, scientifically valid, and feasible.