Beef Versus Whey Protein: The Gut Showdown Self-Experiment
Overview
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Efforia, Inc
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- PROMIS® Scale v1.0 - Gastrointestinal Constipation 9a
Overview
Brief Summary
Test whether a doctor-formulated protein made from real beef is more digestible than standard whey protein powder. For the first 30 days, participants receive either standard whey protein powder or Equip Protein and track how the gut responds weekly. At the 30 day mark, all participants receive the standard Equip protein to track differences in digestability.
Detailed Description
This remotely administered decentralized trial is designed to critically assess the digestive and overall well-being impact of Equip's Prime Protein, a beef-based protein powder, in comparison to standard whey protein. In an era where nutrition claims are often promoted without rigorous testing, Equip is committed to substantiating the benefits of its protein powder through real-world evidence. Over a span of 60 days, this study will employ a cross-over design whereby participants will document their digestive experiences, energy levels, and overall health, providing valuable insights into how each protein source influences gut comfort and tolerability.
Participants in this study will either start with the standard whey protein and transition to Equip's chocolate-flavored beef protein at the halfway mark or use Equip's product from the outset. This methodology allows for a comprehensive comparison between the two protein sources, aiming to offer individuals a clearer understanding of how different proteins affect their gut health. Through daily structured surveys and feedback, participants will not only learn how their bodies respond to each protein type but also contribute to critical data that could potentially elevate the standard of evidence within the supplement industry.
The significance of this study extends beyond individual health, aiming to challenge and reshape the broader nutrition and supplement landscape. Most companies in the supplement industry base their claims on marketing rather than empirical evidence. By conducting this rigorous, real-world study, Equip is holding itself to a standard of scientific accountability and transparency. The findings from this trial will not only inform participants' choices but also aim to advance the entire field towards cleaner, evidence-based nutrition practices. By identifying which protein source better supports digestion and overall comfort, this study stands to make a meaningful impact on public health and industry standards, moving the focus from marketing claims to measurable, scientifically valid outcomes.
More information can be found on the study recruitment page here: https://app.efforia.com/prime-protein-chocolate-gastrointestinal-health/
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Health Services Research
- Masking
- Single (Participant)
Masking Description
Protein powders have individually been packaged into indeterminate packages so that participants are unaware of which product they are testing. They are informed prior to study start that they may be given whey or beef protein.
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Can read and understand English.
- •US resident.
- •Willing and able to follow the requirements of the protocol.
- •Willing to purchase study materials.
Exclusion Criteria
- •Individuals with Beef Allergy
- •Individuals with Whey Allergy
- •Individuals with Dairy Allergy
- •Individuals with Serious Digestive Disorders
- •Individuals on a Vegan Diet
- •Individuals with Chronic Kidney Disease
- •Pregnant or Nursing Individuals
- •Individuals with Gout
Arms & Interventions
Crossover longitudinal where participants act as their own control - whey arm
30 % of participants receive a standard chocolate whey protein, followed by the Equip chocolate beef protein.
Intervention: Beef protein (Dietary Supplement)
Crossover longitudinal where participants act as their own control - whey arm
30 % of participants receive a standard chocolate whey protein, followed by the Equip chocolate beef protein.
Intervention: Chocolate whey protein (Dietary Supplement)
Crossover longitudinal where participants act as their own control - beef arm
70 % of participants receive Equip chocolate protein followed by another Equip chocolate protein.
Intervention: Beef protein (Dietary Supplement)
Outcomes
Primary Outcomes
PROMIS® Scale v1.0 - Gastrointestinal Constipation 9a
Time Frame: Change from baseline (Day 1-5) in gastrointestinal constipation at 4 weeks after the start of the intervention (Day 25-35)
Outcome Measure Description: Change from baseline in gastrointestinal constipation as assessed by the Patient-Reported Outcomes Measurement Information System® (PROMIS®) Gastrointestinal Constipation 9a Scale, Version 1.0, which evaluates constipation frequency, severity, and impact over the past 7 days. Scoring: Each item is scored 1-5; total raw scores are converted to a T-score metric (range \~25-85). Higher scores indicate more severe constipation (worse outcome).
PROMIS® Scale v1.0 - Gastrointestinal Belly Pain 5a Survey
Time Frame: Change from baseline (Day 1-5) in gastrointestinal belly pain at 4 weeks after the start of the intervention (Day 25-35)
Outcome Measure Description: Change from baseline in gastrointestinal belly pain as assessed by the Patient-Reported Outcomes Measurement Information System® (PROMIS® Gastrointestinal Belly Pain 5a Scale, Version 1.0), measuring frequency and intensity of abdominal pain over the past 7 days. Scoring: Each item scored 1-5; T-score conversion range \~25-80. Higher scores indicate more severe belly pain (worse outcome).
PROMIS® Scale v1.0 - Gastrointestinal Bowel Incontinence 4a Survey
Time Frame: Change from baseline (Day 1-5) in gastrointestinal bowel incontinence at 8 weeks after the start of the intervention (Day 55-65)
Outcome Measure Description: Change from baseline in gastrointestinal bowel incontinence as assessed by the Patient-Reported Outcomes Measurement Information System® (PROMIS® Gastrointestinal Bowel Incontinence 4a Scale, Version 1.0), evaluating frequency and impact of bowel incontinence over the past 7 days. Scoring: Each item scored 1-5; T-score conversion range \~25-80. Higher scores indicate more severe bowel incontinence (worse outcome).
PROMIS Scale v1.1 - Gastrointestinal Gas and Bloating 13a
Time Frame: Change from baseline (Day 1-5) in gastrointestinal gas and bloating at 4 weeks after the start of the intervention (Day 25-35)
Outcome Measure Description: Change from baseline in gastrointestinal gas and bloating as assessed by the Patient-Reported Outcomes Measurement Information System® (PROMIS® Gastrointestinal Gas and Bloating 13a Scale, Version 1.1), which evaluates frequency and intensity over the past 7 days. Scoring: Each item scored 1-5; T-score conversion range \~25-85. Higher scores indicate more severe gas and bloating (worse outcome).
Secondary Outcomes
No secondary outcomes reported