Healthy volunteers try a special enteral nutrition plan to see its gut effects
Official title: Healthy Volunteers Enteral Nutrition Study
Run by University of Pennsylvania · NCT07426003 · Data updated 2026-11-12
Healthy volunteers will test two eating plans using a complete nutrition formula to see how it changes their gut transit time and microbiome.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 70 Years |
| Sex | All |
| Enrollment | 25 (estimated) |
| Sponsor | University of Pennsylvania Academic / other |
| Locations | 1 site (Philadelphia, Pennsylvania) |
| Status | Recruiting |
| Started | June 17, 2026 |
| Main results expected | April 2027 |
| Study ends | May 2027 |
| Registry record updated | August 6, 2026 |
| Trial ID | NCT07426003 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are English-speaking healthy adults aged with BMI between 20 and 30 who can consent.
✕Probably not a fit
Participants with inflammatory bowel disease, celiac disease, or other listed exclusion criteria may not benefit and are not eligible.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This outpatient study compares two dietary approaches over three days in 20 healthy adults. Participants are randomized to either Partial Enteral Nutrition (60% calories from Kate Farms Peptide 1.5 and 40% from the Crohn's disease exclusion diet) or Exclusive Enteral Nutrition (100% calories from Kate Farms Peptide 1.5). The study collects blood and urine samples during the observation period and analyzes colon transit time, microbiome, and metabolome changes. The trial aims to understand how these nutrition strategies affect gut biology in the absence of intestinal inflammation.
Why it matters
Potential benefit: If successful, findings could inform dietary strategies to influence gut health and microbiome composition.
How similar studies have gone: Previous studies have explored diet-microbiome interactions, but this specific enteral nutrition approach in healthy volunteers is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Must be able to read and understand English 2. Must be able to sign a consent form for the study Exclusion Criteria: 1. BMI \<20 or \>30 2. Unintentional weight loss of \>10% in the last 3-6 months 3. Kidney disease 4. Diagnosis of cirrhosis 5. Taking diuretics 6. Anemia - Hemoglobin \<lower limit of normal in men or \<10 g/dL in women. 7. Taking iron supplements within 2 weeks for Visit 2.1 8. Taking prebiotic or probiotic supplements or any supplement including a multivitamin within 2 weeks of Visit 2.1 9. Taking antibiotics less than 4 weeks prior to Visit 2.1 10. Diarrhea in the 2 weeks prior to Visit 2.1 11. Diabetes mellitus 12. Diagnosis of congestive heart failure 13. Diagnosis of inflammatory bowel disease or celiac disease 14. Bowel resection other than an appendectomy 15. Pregnancy or breastfeeding 16. Intolerance or allergy to nutritional formula, chicken, eggs, apples, banana, potatoes 17. Using protein supplements, including powder added to food or drinks within 2 weeks of Visit 2.1 18. Baseline bowel frequency less than every 2 days or greater than 3 times daily 19. Student or employee of any one of the investigators. 20. Anyone who cannot receive study payment (e.g. visa constraints). 21. Any condition that the investigator feels may limit the volunteer's ability to complete the study protocol.
Where it's running
-
Penn Center for Advance Medicine, University of Pennsylvania
Philadelphia, Pennsylvania, United States Recruiting
Study contacts
- Principal investigator: James Lewis, MD, MSCE — University of Pennsylvania
- Study coordinator: Raksha Shastry, MPH
- Email: Raksha.Shastry@PennMedicine.upenn.edu
- Phone: 267-896-3160
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.