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RecruitingNot ApplicableNCT07426003

Healthy Volunteers Enteral Nutrition Study (HEN)

Healthy Volunteers Enteral Nutrition Study

Sponsor

James Lewis

Enrollment

25 participants

Start Date

Jun 17, 2026

Study Type

INTERVENTIONAL

Conditions

Enteral Nutrition's Effect on the Gut

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.

Eligibility

Min Age: 18 YearsMax Age: 70 Years

Inclusion Criteria2

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

Exclusion Criteria21

  • 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
  • Intolerance or allergy to nutritional formula, chicken, eggs, apples, banana, potatoes
  • Using protein supplements, including powder added to food or drinks within 2 weeks of Visit 2.1
  • Baseline bowel frequency less than every 2 days or greater than 3 times daily
  • Student or employee of any one of the investigators.
  • Anyone who cannot receive study payment (e.g. visa constraints).
  • Any condition that the investigator feels may limit the volunteer's ability to complete the study protocol.

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Interventions

DIETARY_SUPPLEMENTKate Farms Peptide 1.5

Kate Farms Peptide 1.5

OTHERCrohn's disease exclusion diet

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

Locations(1)

Penn Center for Advance Medicine, University of Pennsylvania

Philadelphia, Pennsylvania, United States

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NCT07426003