25 Participants NeededMy employer runs this trial

Enteral Nutrition for Healthy Volunteers

(HEN Trial)

AS
RS
HS
Overseen ByHEN Study General Email
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests how a special formula drink, Kate Farms Peptide 1.5, affects healthy individuals. Researchers aim to observe the effects of this formula when used as a partial or complete substitute for regular food, without gut inflammation. Participants will either replace most meals with the formula while following a specific diet or consume only the formula with water, coffee, and tea for a short period. Individuals who are generally healthy, not experiencing significant weight changes, and do not have conditions like diabetes, kidney disease, or food allergies might be suitable candidates. As an unphased trial, this study offers participants a unique opportunity to contribute to foundational research on nutritional alternatives.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that Kate Farms Peptide 1.5 is generally safe and easy to digest. This plant-based formula provides all the essential nutrients the body needs and is free from common allergens, making it suitable for individuals with allergies or sensitivities.

Often used for tube feeding, the formula minimizes contamination risk. It contains 25 vitamins and minerals that support overall health. Available data reports no specific negative side effects, indicating it is well-tolerated by those who have used it for nutrition support.

While typically used for tube feeding, this trial involves drinking the formula. Its design for safety and complete nutrition should reassure participants considering joining the study.12345

Why are researchers excited about this trial?

Researchers are excited about Kate Farms Peptide 1.5 because it offers a unique approach to managing diet in people following the Crohn's Disease Exclusion Diet. Unlike traditional dietary treatments that might rely heavily on solid food modifications, this formula provides a liquid nutrition option that can be used exclusively or partially. Specifically, it delivers essential nutrients in a peptide form, which can be easier for the body to absorb and may be gentler on the digestive system. This could offer a more straightforward and potentially more effective way to maintain nutritional needs while adhering to the dietary restrictions necessary for managing Crohn's disease.

What evidence suggests that enteral nutrition is effective for healthy volunteers?

Research has shown that Kate Farms Peptide 1.5 can improve digestive health and nutrition. In studies, participants reported a 35-45% decrease in digestive issues such as constipation, bloating, and diarrhea. Additionally, 90.6% of participants either gained or maintained their weight, demonstrating its nutritional benefits. Another study found that 67% of participants experienced better digestive symptoms, including easier bowel movements and less stomach discomfort. This trial will evaluate Kate Farms Peptide 1.5 in two contexts: one group will consume it exclusively, while another will use it as part of a partial enteral nutrition plan alongside the Crohn's Disease Exclusion Diet. This evidence suggests that Kate Farms Peptide 1.5 is a promising choice for those needing nutritional support with fewer digestive problems.678910

Who Is on the Research Team?

JL

James Lewis, MD, MSCE

Principal Investigator

University of Pennsylvania

Are You a Good Fit for This Trial?

This trial is for healthy adults who can read and understand English and are able to give consent. It is not for people with current health issues or those unable to participate fully.

Inclusion Criteria

1. Must be able to read and understand English
2. Must be able to sign a consent form for the study

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week
1 visit (in-person)

Treatment

Participants are assigned to either Partial Enteral Nutrition (PEN) or Exclusive Enteral Nutrition (EEN) for 3 days

3 days
4 visits (in-person)

Follow-up

Participants are monitored for changes in colon transit time, microbiome, and metabolome

1 week
1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

  • Kate Farms Peptide 1.5

Trial Overview

The study tests the effects of a special nutrition formula (Kate Farms Peptide 1.5) and a Crohn's disease exclusion diet in healthy volunteers, aiming to see how these affect the body when there’s no gut inflammation.

How Is the Trial Designed?

2

Treatment groups

Active Control

Group I: Partial Enteral Nutrition and the Crohn's Disease Exclusion DietActive Control2 Interventions
Group II: Exclusive enteral nutritionActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

James Lewis

Lead Sponsor

Trials
4
Recruited
250+

Citations

Kate Farms Releases New Clinical Study Demonstrating ...

35-45% reduction in episodes of constipation, bloating, vomiting and diarrhea 90.6% gained or maintained weight 41% better adherence

Retrospective Cohort Study Demonstrates Tolerance and ...

38.4% experienced improvement in GI tolerance, 56.2% experienced no change, and 5.5% reported worsening GI tolerance. There was a 95% adherence ...

Patient-reported outcomes on gastrointestinal tolerance and ...

Enteral Nutrition through a feeding tube or orally can improve patient outcomes when tolerated to achieve nutritional requirements.

Partial-enteral Nutrition for Crohn's Disease

These results suggest that Kate Farms Peptide 1.5 may effectively support better health during Crohn's disease flares.

Patient-Reported Outcomes Indicate Improved Nutrition and ...

Patients who switched to Kate Farms reported: 67% improved digestive symptoms, including easier bowel movements; less reflux, abdominal discomfort, bloating,

Peptide 1.5 | Organic Tube Feeding Formula

Organic plant-based peptide formula that's nutritionally complete without common allergens. Specifically designed for tube feeding and people with impaired ...

Tube Feeding Use | Kate Farms

All Kate Farms medical formulas are suitable for tube feeding use. Based on the ASPEN guidelines, Kate Farms products meet criteria to have an 8-hour hang ...

Pediatric Peptide 1.5 - Tube Feeding Formula

Delicious, organic plant-based formula. Nutritionally complete without common allergens. Designed for children with impaired digestion, ages 1-13.

Choosing the Best Enteral Nutrition Formula for Your Child

You're on a new tube-feeding journey, and we're here to help you navigate all the different formula options and nutrition information.

Storage Guidelines - Kate Farms

for tube feeds, Do not store at temperatures above 110oF for more than 2 weeks. appears damaged or leaking in any way,