Healthy Volunteers Enteral Nutrition Study (HEN)

NCT07426003 | Not Yet Recruiting

• 1 other identifier: 860217
• Study Type: interventional
• Target: 25
• Locations: 0 countries
• Sites: N/A

Brief Summary

This research study is being conducted to determine the effects of enteral nutrition on healthy people. Enteral nutrition for the purpose of this study refers to the use of a specially developed formula taken by mouth that provides all essential nutrition either in the absence of food or to supplement the intake of foods. Enteral nutrition can be used for many reasons, such as to gain or lose weight, to treat food allergies, or to reduce inflammation in certain intestinal diseases. We would like to understand the effects of enteral nutrition in the absence of intestinal inflammation.

Conditions

Enteral Nutrition's Effect on the Gut

Keywords

enteral nutrition; healthy volunteers

Outcome Measures

Primary Outcomes (1)

• number of sitz markers at 72 hours

  Number of sitz markers that are present in an abdominal x-ray 72 hours after the participant takes the sitz mark capsule

  72 hours after taking the sitzmark capsule

Study Arms (2)

Partial Enteral Nutrition and the Crohn's Disease Exclusion Diet

ACTIVE COMPARATOR

Participants will drink Kate Farms Peptide 1.5 for 60% of their calories and follow the Crohn's Disease Exclusion Diet for the remainder of their calories

Dietary Supplement: Kate Farms Peptide 1.5; Other: Crohn's disease exclusion diet

Exclusive enteral nutrition

ACTIVE COMPARATOR

Participants will consume Kate Farms Peptide 1.5 exclusively except water, and coffee and tea with no sweetner or cream/milk for 3 days

Dietary Supplement: Kate Farms Peptide 1.5

Interventions

Kate Farms Peptide 1.5 DIETARY_SUPPLEMENT

Kate Farms Peptide 1.5

Exclusive enteral nutrition; Partial Enteral Nutrition and the Crohn's Disease Exclusion Diet

Crohn's disease exclusion diet OTHER

This study will use the components of the Crohn's disease exclusion diet Phase 1 which includes chicken breast, eggs, potatoes, bananas and apples

Partial Enteral Nutrition and the Crohn's Disease Exclusion Diet

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Must be able to read and understand English
• Must be able to sign a consent form for the study

You may not qualify if:

• BMI \<20 or \>30
• Unintentional weight loss of \>10% in the last 3-6 months
• Kidney disease
• Diagnosis of cirrhosis
• Taking diuretics
• Anemia - Hemoglobin \<lower limit of normal in men or \<10 g/dL in women.
• Taking iron supplements within 2 weeks for Visit 2.1
• Taking prebiotic or probiotic supplements or any supplement including a multivitamin within 2 weeks of Visit 2.1
• Taking antibiotics less than 4 weeks prior to Visit 2.1
• Diarrhea in the 2 weeks prior to Visit 2.1
• Diabetes mellitus
• Diagnosis of congestive heart failure
• Diagnosis of inflammatory bowel disease or celiac disease
• Bowel resection other than an appendectomy
• Pregnancy or breastfeeding

Sponsors & Collaborators

• James Lewis: lead

Study Officials

• James Lewis, MD, MSCE

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alesia Smith, MS

CONTACT

445-242-3237; alesia.smith@pennmedicine.upenn.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Medicine and Epidemiology

Study Record Dates

• First Submitted: February 16, 2026
• First Posted: February 23, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: February 24, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share