Important Information

Whey protein is widely used to support muscle maintenance and growth. Prime Protein is a beef-isolate protein product marketed as a complete-protein alternative. This study is designed to compare the two products during everyday use and determine whether changes in lean mass and body composition are similar or different.

The primary outcome is change in DEXA-measured lean muscle mass from baseline to follow-up. Other outcomes include total fat mass, body-fat percentage, appendicular lean mass, gastrointestinal gas and bloating, body image and self-perception, adherence, and side effects.

This is a randomized, controlled, two-arm study. Approximately 70% of participants will be assigned to Prime Protein and 30% to a whey-protein control. The study is conducted under real-world conditions and is not blinded. Differences in diet, exercise, hydration, weight, sleep, medication or supplement use, DEXA equipment or positioning, adherence, and other factors may affect the results. DEXA measures body composition but does not directly measure muscle-protein synthesis. This study may identify meaningful patterns but may not definitively establish equivalence or superiority.

This study is hosted on Efforia under the Minimal Risk Citizen Science Umbrella Protocol. Matthew Amsden is the Principal Investigator, and Dr. Viral Patel serves as Sub-Investigator with safety and adverse-event oversight.

Prime Protein is a chocolate-flavored dietary supplement providing approximately 21 grams of complete protein from grass-fed beef isolate per serving, with naturally occurring collagen and gelatin.

The whey-protein control is a whey-based protein powder formulated for use as the comparison product. Approximately 30% of participants will receive the control. You cannot choose your assignment, and paying to participate does not guarantee that you will receive Prime Protein.

Review the label on the product you receive before use. Ingredients and allergen statements on the package are authoritative. Do not use the product if you are allergic or sensitive to an ingredient, if the packaging appears damaged or tampered with, or if a qualified clinician has advised you to restrict protein or avoid the product.

Both products are consumer dietary supplements, not approved treatments for muscle loss or another medical condition. Their safety and effectiveness may vary between individuals.

If you join, you will be asked to:

• Provide participant information and describe your goals, expectations, health background, and usual routine.
• Complete a baseline DEXA scan during the assigned baseline window to measure lean mass and body composition.
• Complete baseline questionnaires about gastrointestinal gas and bloating and body image and self-perception.
• After completing the required baseline activities, take one serving of your randomly assigned study protein each day for approximately 90 days, mixed and used according to the product and study instructions.
• Record your assigned protein use through the daily Efforia task.
• Complete a side-effect check-in around treatment Day 14.
• Complete gastrointestinal gas-and-bloating assessments beginning around Day 14 and then approximately weekly as assigned.
• Complete body-image and self-assessment questionnaires approximately every 30 days as assigned.
• Complete a follow-up DEXA scan around treatment Day 90, within the assigned completion window.
• Continue your usual diet and activity routine. When possible, do not begin a new workout program, diet, weight-loss regimen, muscle-building supplement, anabolic agent, performance-enhancing drug, medication, or other major lifestyle change during the study. Report meaningful changes honestly because they may affect interpretation.
• Complete tasks within their assigned windows and report missed servings, side effects, illness, injuries, major routine changes, or other protocol deviations.
• Seek needed medical care first and then report a concerning symptom or possible study-related problem to Efforia.

Two DEXA appointments are expected to take about 30 minutes each. Daily logging, questionnaires, and other study activities require additional time spread across the study. Appointment availability and travel time will vary by location.

Stop using the study product and seek urgent medical care for trouble breathing; swelling of the face, lips, tongue, or throat; fainting; severe or persistent abdominal pain; blood in vomit or stool; or another possible emergency. In the United States, call 911. Contact Efforia only after obtaining necessary care.

Do not join if you are under 18 or cannot provide informed consent; are pregnant or may be pregnant; have a known allergy or serious sensitivity to milk, whey, beef-derived protein, or another listed product ingredient; have been advised to restrict protein or avoid either study product; cannot safely complete DEXA scans; or cannot follow the assigned daily regimen and study procedures.

Speak with a qualified healthcare professional who knows your history before joining if you are trying to conceive or breastfeeding; have kidney or liver disease, gout, recurrent kidney stones, a protein or amino-acid metabolism disorder, significant gastrointestinal disease or malabsorption, diabetes or unstable blood sugar, a history of severe allergic reaction, an eating disorder or body dysmorphia, a recent major illness or surgery, active cancer treatment, an unstable medical condition, or a medically supervised nutrition plan; take medicines or treatments that require stable nutrition, weight, or protein intake; have implanted hardware or another condition that may affect DEXA accuracy; have had recent or frequent radiation-based imaging; or are participating in another intervention study.

Confirm with the DEXA provider that you are within the scanner’s size and weight limits and follow all site screening and safety instructions. Efforia cannot determine whether a protein supplement or DEXA scan is medically appropriate for you. Do not change prescribed treatment or delay needed medical care for this study.

You may learn how your assigned protein is associated with your own lean mass, body composition, digestive comfort, and body-image or self-perception measures. You may experience improved convenience, protein intake, muscle maintenance or growth, or digestive tolerance, but you may receive no benefit, experience no improvement, or feel worse. No personal benefit is promised.

Personalized results are informational and are not a diagnosis or medical advice. Your de-identified data may contribute to generalizable knowledge about Prime Protein and whey and may help inform future research.

Your main alternative is not to participate. You may continue your usual diet and exercise routine; purchase and use or not use a commercially available protein product outside the study; obtain a commercial body-composition assessment separately; or consult a physician, registered dietitian, or other qualified professional about your nutrition, training, or health goals. You do not need to join this study to receive medical care.

You will pay $121 to participate. The study record identifies this amount as covering study-related products, materials, and supplies. You will not receive wages or payment for your time. Depending on study arrangements and your location, you may also be responsible for travel, parking, internet or mobile-data charges, and any medical care you seek.

Paying does not guarantee assignment to Prime Protein, muscle growth, improved body composition, symptom improvement, a clinically useful result, or any other benefit. Refunds, if any, follow the applicable Efforia return policy.

Efforia receives transaction revenue related to products or services included in protocols hosted on its platform, and Equip Foods or related parties have an interest in the product being studied. These interests create potential financial conflicts of interest. The randomized design and objective DEXA outcomes are intended to strengthen the evidence, but findings should still be interpreted in light of these interests and the study’s real-world limitations.

Seek local, in-person medical care immediately if needed. Efforia cannot provide emergency care, diagnosis, or treatment. After receiving necessary care, report the problem, side effect, or possible study-related injury to help@efforia.com so the study team can evaluate whether action is needed to protect participants.

Efforia does not offer financial compensation for study-related injury and does not commit to provide free medical care or pay medical expenses resulting from participation. You are not giving up any legal rights by agreeing to participate.

Efforia may collect information needed to operate and analyze the study, including account and contact information, shipping and appointment information, demographic and health questionnaire responses, goals and expectations, product assignment, product-use and adherence records, side-effect and safety reports, task-completion data, body-image and gastrointestinal questionnaire responses, and DEXA measurements such as lean mass, fat mass, body-fat percentage, and appendicular lean mass.

DEXA providers, fulfillment partners, and other service providers may collect or process information needed to schedule scans, deliver study products, provide support, or transmit study data. Those organizations may separately retain information under their own terms and privacy practices.

Efforia uses administrative, technical, and organizational safeguards designed to protect your information. Directly identifying information is not made available to ordinary site staff for this study. Authorized Efforia personnel and service providers may access information when needed to operate the platform, fulfill products, coordinate DEXA services, provide support, address safety concerns, or comply with law. The Efforia Institutional Review Board, regulators, auditors, and other authorized oversight bodies may review study records. Absolute confidentiality cannot be guaranteed.

Your name and other direct identifiers will not be included in publications or public presentations without your permission. De-identified or aggregated information may be used to generate personal results, analyze and report this study, evaluate the products and protocol, and support future research. Review the Efforia Privacy Policy.

You may receive study notifications by email, SMS, or push notification according to your communication settings. Protect your device and account credentials and avoid using an unsecured shared device for study activities.

Your participation is voluntary. Refusing to participate will not affect your usual healthcare or involve a penalty or loss of benefits to which you are entitled. If you join, you may stop the assigned product or leave the study at any time and for any reason.

To leave, go to your Efforia Profile, select Your Protocols, and choose Leave, or contact help@efforia.com. Refunds, if any, follow the applicable Efforia return policy; shipped or used products and completed services may not be refundable.

If you withdraw, no new study information will be collected from you except information needed for safety, legal, or administrative reasons. Information already collected may still be retained and used to protect research integrity and as permitted by this consent and applicable law.

The study team may end your participation for safety concerns, failure to follow study procedures, study closure, product or DEXA availability, or other administrative or scientific reasons.

If new information becomes available that may affect the study’s risks or benefits or your willingness to continue, you will be notified so you can decide whether to remain. You may receive personalized DEXA and questionnaire results and overall study findings when available. Results may contain measurement error, are informational rather than diagnostic, and should not replace advice from a qualified healthcare professional.

For questions about study tasks, products, DEXA scheduling, side effects, withdrawal, or technical support, contact help@efforia.com.

This study is reviewed under the Efforia Institutional Review Board. For questions about your rights as a research participant, concerns or complaints about the study, or to speak with someone outside the study team, contact ethics@efforia.com.

If California law applies to you, you have the right to:

• Be informed of the nature and purpose of the experiment.
• Receive an explanation of the procedures, expected duration, reasonably foreseeable risks or discomforts, and expected benefits.
• Receive an explanation of appropriate alternatives that might be advantageous.
• Be informed of available medical treatment, if any, should complications arise.
• Ask questions about the study and receive answers.
• Withdraw consent and discontinue participation at any time without prejudice.
• Receive a copy of this consent form.
• Decide whether to participate without coercion or undue influence.

By accepting this consent, you confirm that you have read and understood the information above; have had the opportunity to ask questions; are voluntarily choosing to participate; understand that you will be randomly assigned and may receive the whey-protein control; authorize Efforia to collect, use, and share study information as described; understand that you may withdraw at any time; and are not giving up any legal rights.

If you do not agree, do not accept this form or participate in the study.