60 Day
Loam Pre-biotic Fiber Personal Experimentation Challenge
| STUDY TITLE | Loam Pre-biotic Fiber Personal Experimentation Challenge |
|---|---|
| Submitted under umbrella |
|
| Date submitted |
Feb 6, 2026 |
| 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 | |
| Informed consent | |
| Study author |
Matthew Amsden, Kieran Mathew |
| Principal investigator |
Matthew Amsden |
| Sub-Investigator for Adverse Events |
Dr. Viral Patel |
| Description |
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| Participant engagement length |
60 Days |
| Sponsor |
This study is made possible by your payment to cover all supplies and expenses required to participate. |
| Cost to participant |
$126 |
| Included products & services |
— |
| Outcome measures |
PROMIS® Scale v1.0 – Gastrointestinal Constipation 9a PROMIS® Scale v1.0 – Gastrointestinal Belly Pain 5a Survey PROMIS® Scale v1.0 – Gastrointestinal Bowel Incontinence 4a Survey PROMIS Scale v1.1 – Gastrointestinal Gas and Bloating 13a |
| 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” |
Yes |
| ClinicalTrials.gov |
Yes |
| Commitment 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
The Intervention
Included Products & Services
Study Design & Methodology
Inappropriate Participants & Inclusion/Exclusion
Under the Efforia minimal risk protocol, within which this study is reviewed for safety and human subjects ethics, all individuals over the age of consent are eligible, however, it is the responsibility of participants to determine if their unique circumstances make participation inappropriate.
| Category of Individual | Contraindications | Reason |
|---|---|---|
| Individuals with Beef Allergy | Should avoid consuming beef protein | Risk of allergic reaction, which can range from mild to severe |
| Individuals with Dairy Allergy | Should avoid consuming whey protein | Risk of allergic reaction, which can range from mild to severe |
| Individuals with Serious Digestive Disorders | May need to evaluate participation with a healthcare provider | Potential for discomfort or adverse effects on gut health |
| Individuals on a Vegan Diet | Should avoid the study due to inclusion of animal products | Ethical and dietary preferences against animal-based proteins |
| Individuals with Chronic Kidney Disease | Should consult with a healthcare provider before participation | High protein intake can strain kidney function |
| Pregnant or Nursing Individuals | Should consult with a healthcare provider | Changes in diet may impact maternal and fetal health |
| Individuals with Gout | May need to evaluate participation due to purine content in beef | Higher purine content in beef can exacerbate gout symptoms |
| Individuals with Severe Economic Constraints | Should consider cost implications of protein sources | Concerns about the affordability of beef or whey protein supplements |