Digestion
Conditions
Keywords
digestion, gut, bloating
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/
Interventions
DIETARY_SUPPLEMENTBeef protein
Original beef protein powder chocolate flavor, manufactured by Equip, packed with 21g of complete protein, plus naturally occurring collagen and gelatin
DIETARY_SUPPLEMENTChocolate whey protein
Whey protein isolate is a dairy-derived protein powder containing ≥90% protein by weight, with minimal lactose and fat. The product is provided as a flavored powder and administered orally when mixed with water. The product does not contain added bioactive ingredients beyond standard whey protein isolate.
Sponsors
Efforia, Inc
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Subject)
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.
Intervention model description
Crossover observational where participants act as their own control
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PROMIS® Scale v1.0 - Gastrointestinal Constipation 9a | 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 | 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 | 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 | 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). |
Countries
United States
Outcome results
None listed