- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07477223
Beef Versus Whey Protein: The Gut Showdown Self-Experiment
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
New York
-
New York, New York, United States, 10003
- Efforia
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Sham Comparator: 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.
|
Original beef protein powder chocolate flavor, manufactured by Equip, packed with 21g of complete protein, plus naturally occurring collagen and gelatin
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.
|
|
Experimental: Crossover longitudinal where participants act as their own control - beef arm
70 % of participants receive Equip chocolate protein followed by another Equip chocolate protein.
|
Original beef protein powder chocolate flavor, manufactured by Equip, packed with 21g of complete protein, plus naturally occurring collagen and gelatin
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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). |
Change from baseline (Day 1-5) in gastrointestinal constipation at 4 weeks after the start of the intervention (Day 25-35)
|
|
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). |
Change from baseline (Day 1-5) in gastrointestinal belly pain at 4 weeks after the start of the intervention (Day 25-35)
|
|
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). |
Change from baseline (Day 1-5) in gastrointestinal bowel incontinence at 8 weeks after the start of the intervention (Day 55-65)
|
|
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). |
Change from baseline (Day 1-5) in gastrointestinal gas and bloating at 4 weeks after the start of the intervention (Day 25-35)
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Digestion
-
Deerland EnzymesKennesaw State UniversityRecruitingSatiety | Indigestion | Digestive Health | Protein Digestion | Carbohydrate Digestion | Fat DigestionUnited States
-
Wageningen UniversityCompleted
-
Newcastle UniversityCompletedTriacylglycerol DigestionUnited Kingdom
-
DSM Food SpecialtiesCompleted
-
Maastricht University Medical CenterFrieslandCampinaCompletedProtein Digestion & AbsorptionNetherlands
-
NestléCompletedHappiness | Digestion | TemperamentChina
-
NIZO Food ResearchFrieslandCampinaCompleted
-
Wageningen UniversityFrieslandCampinaCompleted
Clinical Trials on Beef protein
-
University of Missouri-ColumbiaNational Cattlemen's Beef AssociationCompletedObesity | Poor Glycemic Control | Dietary Interventions
-
University of ArkansasCompleted
-
University of Illinois at Urbana-ChampaignNational Cattlemen's Beef AssociationCompleted
-
University of California, DavisNational Cattlemen's Beef Association, a contractor to the Beef CheckoffRecruitingVascular Diseases | Metabolic Diseases | Inflammation | Zinc DeficiencyUnited States
-
McGill UniversityCompletedAppetitive Behavior | AminoacidemiaCanada
-
Maastricht University Medical CenterCompleted
-
University of GreenwichCompleted
-
University of Colorado, DenverNational Cattlemen's Beef AssociationCompletedWeight LossUnited States
-
University of Texas at AustinNational Cattlemen's Beef AssociationCompletedEating Behavior | Breast Feeding, Exclusive | Glycemic ResponseUnited States
-
Kasper DideriksenUnknownMuscle Protein Synthesis | Meat Protein Supplements | Protein Absorption and Amino Acid AvailabilityDenmark